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9. In patients eligible for meniscal surgery who first receive physical therapy, multivariable prognostic models cannot predict who will eventually undergo surgery

Author

Noorduyn, J.C.A., Teuwen, M.M.H., Graaf, V.A. van de, Willigenburg, N.W., Schavemaker, M., Dijk, R. van, Scholten-Peeters, G.G.M., Heymans, M.W., Coppieters, M.W., Poolman, R.W., Scholtes, V.A.B., Mutsaerts, E.L.A.R., Wolkenfelt, J., Krijnen, M.R., Deurzen, D.F.P. van, Moojen, D.J.F., Bloembergen, C.H., Gast, A.G. de, Snijders, T., Halma, J.J., Saris, D.B.F., Wolterbeek, N., Neeter, C., Kerkhoffs, D.M.M.J., Peters, R.W., Brand, I.C.J.B. van den, Vos-Jakobs, S. de, Spoor, A.B., Gosens, T., Rezaie, W., Hofstee, D.J., Burger, B.J., Haverkamp, D., Vervest, A.M.J.S., Rheenen, T.A. van, Wijsbek, A.E., Arkel, E.R.A. van, Thomassen, B.J.W., Sprague, S., Mol, B.W.J., Tulder, M.W. van, Kraan, J. van der, Escape Res Grp, Surgery, Amsterdam Movement Sciences, Epidemiology and Data Science, APH - Methodology, APH - Personalized Medicine, Neuromechanics, AMS - Musculoskeletal Health, AMS - Rehabilitation & Development, Faculty of Behavioural and Movement Sciences, and APH - Societal Participation & Health

Subjects
medicine.medical_specialty, Knee Joint, Meniscal tears, Knee Injuries, Meniscus (anatomy), Logistic regression, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, medicine, Humans, Knee, Meniscus, Orthopedics and Sports Medicine, In patient, 030212 general & internal medicine, Physical Therapy Modalities, Prognostic models, Aged, business.industry, 030229 sport sciences, Middle Aged, Prognosis, Explained variation, Tibial Meniscus Injuries, Surgery, medicine.anatomical_structure, Orthopedic surgery, Physical therapy, Prognostic model, business
Abstract

Purpose Although physical therapy is the recommended treatment in patients over 45 years old with a degenerative meniscal tear, 24% still opt for meniscal surgery. The aim was to identify those patients with a degenerative meniscal tear who will undergo surgery following physical therapy. Methods The data for this study were generated in the physical therapy arm of the ESCAPE trial, a randomized clinical trial investigating the effectiveness of surgery versus physical therapy in patients of 45–70 years old, with a degenerative meniscal tear. At 6 and 24 months patients were divided into two groups: those who did not undergo surgery, and those who did undergo surgery. Two multivariable prognostic models were developed using candidate predictors that were selected from the list of the patients’ baseline variables. A multivariable logistic regression analysis was performed with backward Wald selection and a cut-off of p Results At 6 months, 32/153 patients (20.9%) underwent meniscal surgery following physical therapy. Based on the multivariable regression analysis, patients were more likely to opt for meniscal surgery within 6 months when they had worse knee function, lower education level and a better general physical health status at baseline. At 24 months, 43/153 patients (28.1%) underwent meniscal surgery following physical therapy. Patients were more likely to opt for meniscal surgery within 24 months when they had worse knee function and a lower level of education at baseline at baseline. Both models had a low explained variance (16 and 11%, respectively) and an insufficient predictive accuracy. Conclusion Not all patients with degenerative meniscal tears experience beneficial results following physical therapy. The non-responders to physical therapy could not accurately be predicted by our prognostic models. Level of evidence III.

Published
2021

10. Sustained improvement in renal function with palopegteriparatide in adults with chronic hypoparathyroidism: 2-year results from the phase 3 PaTHway trial

Author

Kamenicky, P., Schwarz, P., Rejnmark, L., Gosmanova, E., Khan, A., Makita, N., Takeuchi, Y., Imanishi, Y., Sprague, S., Shoback, D., Kohlmeier, L., Rubin, M., Palermo, A., Gagnon, C., Tsourdi, E., Zhao, C., Makara, M., Ominsky, M., Lai, B., Ukena, J., Sibley, C., and Shu, A.

Abstract

This post hoc analysis examines the impact of palopegteriparatide on renal function in adults with chronic hypoparathyroidism through week 104 of PaTHway, a phase 3 trial with a randomized, double-blind, placebo-controlled 26-week period and ongoing 156-week open-label extension. Changes in renal function were assessed using eGFR. At week 104, 76 of 82 participants remained in the trial. Of those, 82% had normal albumin-adjusted serum calcium levels (2.07–2.64mmol/L), 97% were independent from conventional therapy, and none required active vitamin D. Mean (SD) serum phosphate (1.1 (0.2) mmol/L) and albumin-adjusted calcium x phosphate product (2.5 (0.4) mmol2/L2) were normal. At week 104, mean (SD) eGFR was 77.8 (14.8) mL/min/1.73m2. With palopegteriparatide treatment mean eGFR increased 8.9 (11.0) mL/min/1.73m2(P<.0001) from baseline to week 52, which was sustained through week 104 (mean (SD) change from baseline 9.0 (10.3) mL/min/1.73 m2(P<0.0001)). By week 104, 61% and 44% of participants had an increase in eGFR of ≥ 5mL/min/1.73 m2and ≥ 10mL/min/1.73 m2, respectively. Palopegteriparatide normalized mean 24-hour urine calcium within 26 weeks, maintaining levels below 6.2mmol/day through week 104 (4.0 (2.3) mmol/day). No cases of nephrolithiasis were reported with palopegteriparatide. Most TEAEs were mild or moderate; no new safety signals reported. These findings show sustained renal safety of palopegteriparatide and suggest that PTH replacement with palopegteriparatide and independence from conventional therapy may not only preserve but improve renal function in adults with chronic hypoparathyroidism.

Published
2024
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11. A Machine Learning Algorithm to Identify Patients at Risk of Unplanned Subsequent Surgery After Intramedullary Nailing for Tibial Shaft Fractures

Author

Bhandari, M., Bulstra, A.E.J., Bzovsky, S., Doornberg, J.N., Goslings, J.C., Hendrickx, L.A.M., Jaarsma, R.L., Jeray, K.J., Kerkhoffs, G.M.M.J., Petrisor, B., Ring, D., Schemitsch, E.H., Swiontkowski, M., Sanders, D., Sprague, S., Tornetta, P., Walter, S.D., Heels-Ansdell, D., Buckingham, L., Leece, P., Viveiros, H., Mignott, T., Ansell, N., Sidorkewicz, N., Agel, J., Bombardier, C., Berlin, J.A., Bosse, M., Browner, B., Gillespie, B., Jones, A., O'Brien, P., Poolman, R., Macleod, M.D., Carey, T., Leitch, K., Bailey, S., Gurr, K., Konito, K., Bartha, C., Low, I., MacBean, L.V., Ramu, M., Reiber, S., Strapp, R., Tieszer, C., Kreder, H.J., Stephen, D.J.G., Axelrod, T.S., Yee, A.J.M., Richards, R.R., Finkelstein, J., Gofton, W., Murnaghan, J., Schatztker, J., Ford, M., Bulmer, B., Conlan, L., Laflamme, G.Y., Berry, G., Beaumont, P., Ranger, P., Laflamme, G.H., Gagnon, S., Malo, M., Fernandes, J., Poirier, M.F., McKee, M.D., Waddell, J.P., Bogoch, E.R., Daniels, T.R., McBroom, R.R., Vicente, M.R., Storey, W., Wild, L.M., McCormack, R., Perey, B., Goetz, T.J., Pate, G., Penner, M.J., Panagiotopoulos, K., Pirani, S., Dommisse, I.G., Loomer, R.L., Stone, T., Moon, K., Zomar, M., Webb, L.X., Teasdall, R.D., Birkedal, J.P., Martin, D.F., Ruch, D.S., Kilgus, D.J., Pollock, D.C., Harris, M.B., Wiesler, E.R., Ward, W.G., Shilt, J.S., Koman, A.L., Poehling, G.G., Kulp, B., Creevy, W.R., Stein, A.B., Bono, C.T., Einhorn, T.A., Brown, T.D., Pacicca, D., Sledge, J.B., Foster, T.E., Voloshin, I., Bolton, J., Carlisle, H., Shaughnessy, L., Obremskey, W.T., LeCroy, C.M., Meinberg, E.G., Messer, T.M., Craig, W.L., Dirschl, D.R., Caudle, R., Harris, T., Elhert, K., Hage, W., Jones, R., Piedrahita, L., Schricker, P.O., Driver, R., Godwin, J., Kregor, P.J., Tennent, G., Truchan, L.M., Sciadini, M., Shuler, F.D., Driver, R.E., Nading, M.A., Neiderstadt, J., Vap, A.R., Vallier, H., Patterson, B.M., Wilber, J.H., Wilber, R.G., Sontich, J.K., Moore, T.A., Brady, D., Cooperman, D.R., Davis, J.A., Cureton, B.A., Mandel, S., Orr, R.D., Sadler, J.T.S., Hussain, T., Rajaratnam, K., Drew, B., Bednar, D.A., Kwok, D.C.H., Pettit, S., Hancock, J., Cole, P.A., Smith, J.J., Brown, G.A., Lange, T.A., Stark, J.G., Levy, B.A., Garaghty, M.J., Salzman, J.G., Schutte, C.A., Tastad, L., Vang, S., Seligson, D., Roberts, C.S., Malkani, A.L., Sanders, L., Dyer, C., Heinsen, J., Smith, L., Madanagopal, S., Frantz-Bush, L., Coupe, K.J., Tucker, J.J., Criswell, A.R., Buckle, R., Rechter, A.J., Sheth, D.S., Urquart, B., Trotscher, T., Anders, M.J., Kowalski, J.M., Fineberg, M.S., Bone, L.B., Phillips, M.J., Rohrbacher, B., Stegemann, P., Mihalko, W.M., Buyea, C., Augustine, S.J., Jackson, W.T., Solis, G., Ero, S.U., Segina, D.N., Berrey, H.B., Agnew, S.G., Fitzpatrick, M., Campbell, L.C., Derting, L., McAdams, J., Ponsen, K.J., Luitse, J., Kloen, P., Joosse, P., Winkelhagen, J., Duivenvoorden, R., Teague, D.C., Davey, J., Sullivan, J.A., Ertl, W.J.J., Puckett, T.A., Pasque, C.B., Tompkins, J.F., Gruel, C.R., Kammerlocher, P., Lehman, T.P., Puffinbarger, W.R., Carl, K.L., Weber, D.W., Jomha, N.M., Goplen, G.R., Masson, E., Beaupre, L.A., Greaves, K.E., Schaump, L.N., Goetz, D.R., Westberry, D.E., Broderick, J.S., Moon, B.S., Tanner, S.L., Powell, J.N., Buckley, R.E., Elves, L., Connolly, S., Abraham, E.P., Steele, T., Ellis, T., Herzberg, A., Crawford, D.E., Hart, R., Hayden, J., Orfaly, R.M., Vigland, T., Vivekaraj, M., Bundy, G.L., Miclau, T., Matityahu, A., Coughlin, R.R., Kandemir, U., McClellan, R.T., Lin, C.H.H., Karges, D., Cramer, K., Watson, J.T., Moed, B., Scott, B., Beck, D.J., Orth, C., Puskas, D., Clark, R., Jones, J., Egol, K.A., Paksima, N., France, M., Wai, E.K., Johnson, G., Wilkinson, R., Gruszczynski, A.T., Vexler, L., Mallee, W.H., Schipper, I.B., and SPRINT Investigators

Subjects
prediction model, intramedullary nailing, machine learning, subsequent surgery, tibia shaft fracture, Orthopedics and Sports Medicine, Surgery, General Medicine
Abstract

Objectives: In the SPRINT trial, 18% of patients with a tibial shaft fracture (TSF) treated with intramedullary nailing (IMN) had one or more unplanned subsequent surgical procedures. It is clinically relevant for surgeon and patient to anticipate unplanned secondary procedures, other than operations that can be readily expected such as reconstructive procedures for soft tissue defects. Therefore, the objective of this study was to develop a machine learning (ML) prediction model using the SPRINT data that can give individual patients and their care team an estimate of their particular probability of an unplanned second surgery. Methods: Patients from the SPRINT trial with unilateral TSFs were randomly divided into a training set (80%) and test set (20%). Five ML algorithms were trained in recognizing patterns associated with subsequent surgery in the training set based on a subset of variables identified by random forest algorithms. Performance of each ML algorithm was evaluated and compared based on (1) area under the ROC curve, (2) calibration slope and intercept, and (3) the Brier score. Results: Total data set comprised 1198 patients, of whom 214 patients (18%) underwent subsequent surgery. Seven variables were used to train ML algorithms: (1) Gustilo-Anderson classification, (2) Tscherne classification, (3) fracture location, (4) fracture gap, (5) polytrauma, (6) injury mechanism, and (7) OTA/AO classification. The best-performing ML algorithm had an area under the ROC curve, calibration slope, calibration intercept, and the Brier score of 0.766, 0.954, -0.002, and 0.120 in the training set and 0.773, 0.922, 0, and 0.119 in the test set, respectively. Conclusions: An ML algorithm was developed to predict the probability of subsequent surgery after IMN for TSFs. This ML algorithm may assist surgeons to inform patients about the probability of subsequent surgery and might help to identify patients who need a different perioperative plan or a more intensive approach.

Published
2021

14. Heterotopic Ossification Following Arthroplasty for Femoral Neck Fracture

Author

Comeau-Gauthier, M., Zura, R.D., Bzovsky, S., Schemitsch, E.H., Axelrod, D., Avram, V., Manjoo, A., Poolman, R.W., Frihagen, F., Heels-Ansdell, D., Bhandari, M., Sprague, S., and HLTH Investigators

Subjects
Male, Reoperation, musculoskeletal diseases, medicine.medical_specialty, WOMAC, medicine.medical_treatment, Arthroplasty, Replacement, Hip, Osteoarthritis, Severity of Illness Index, Article, 03 medical and health sciences, 0302 clinical medicine, Postoperative Complications, Risk Factors, Prevalence, Medicine, Humans, Orthopedics and Sports Medicine, 030212 general & internal medicine, Prospective Studies, Femoral neck, Randomized Controlled Trials as Topic, Hip surgery, 030222 orthopedics, Hip fracture, business.industry, Proportional hazards model, Ossification, Heterotopic, General Medicine, Middle Aged, medicine.disease, Arthroplasty, Surgery, Femoral Neck Fractures, medicine.anatomical_structure, Treatment Outcome, Quality of Life, Heterotopic ossification, Female, business, Follow-Up Studies
Abstract

Background: Heterotopic ossification (HO) is a frequent complication following hip surgery. Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial, we aimed to (1) determine the prevalence of HO following total hip arthroplasty (THA) for femoral neck fracture in patients ≥50 years of age, (2) identify whether HO is associated with an increased risk of revision surgery within 24 months after the fracture, and (3) determine the impact of HO on functional outcomes. Methods: We performed a multivariable Cox regression analysis using revision surgery as the dependent variable and HO as the independent variable. We compared Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores between participants with and those without HO at 24 months. Results: Of 1,441 participants in the study, 287 (19.9%) developed HO within 24 months. HO was not associated with subsequent revision surgery. Grade-III HO was associated with statistically significant and clinically relevant deterioration in the total WOMAC score, which was mainly related to the function component of the score, compared with grade I or II. Conclusions: The impact of grade-III HO on the functional outcomes and quality of life after THA for hip fracture is clinically important, and HO prophylaxis for selected high-risk patients may be appropriate. Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Published
2021

16. Comparison of non-subjective relative fungal biomass measurements to quantify the Leptosphaeria maculans-Brassica napus interaction

Author

Schnippenkoetter, W, Hoque, M, Maher, R, Van de Wouw, A, Hands, P, Rolland, V, Barrett, L, Sprague, S, Schnippenkoetter, W, Hoque, M, Maher, R, Van de Wouw, A, Hands, P, Rolland, V, Barrett, L, and Sprague, S

Abstract

BACKGROUND: Blackleg disease, caused by the fungal pathogen Leptosphaeria maculans, is a serious threat to canola (Brassica napus) production worldwide. Quantitative resistance to this disease is a highly desirable trait but is difficult to precisely phenotype. Visual scores can be subjective and are prone to assessor bias. Methods to assess variation in quantitative resistance more accurately were developed based on quantifying in planta fungal biomass, including the Wheat Germ Agglutinin Chitin Assay (WAC), qPCR and ddPCR assays. RESULTS: Disease assays were conducted by inoculating a range of canola cultivars with L. maculans isolates in glasshouse experiments and assessing fungal biomass in cotyledons, petioles and stem tissue harvested at different timepoints post-inoculation. PCR and WAC assay results were well correlated, repeatable across experiments and host tissues, and able to differentiate fungal biomass in different host-isolate treatments. In addition, the ddPCR assay was shown to differentiate between L. maculans isolates. CONCLUSIONS: The ddPCR assay is more sensitive in detecting pathogens and more adaptable to high-throughput methods by using robotic systems than the WAC assay. Overall, these methods proved accurate and non-subjective, providing alternatives to visual assessments to quantify the L. maculans-B. napus interaction in all plant tissues throughout the progression of the disease in seedlings and mature plants and have potential for fine-scale blackleg resistance phenotyping in canola.

Published
2021

18. What factors increase revision surgery risk when treating displaced femoral neck fractures with arthroplasty

Author

Blankstein, M., Schemitsch, E.H., Bzovsky, S., Poolman, R.W., Frihagen, F., Axelrod, D., Heels-Ansdell, D., Bhandari, M., Sprague, S., Schottel, P.C., and HEALTH Investigators

Subjects
Reoperation, medicine.medical_specialty, Arthroplasty, Replacement, Hip, medicine.medical_treatment, Population, Femoral Neck Fractures, law.invention, 03 medical and health sciences, Femoral head, 0302 clinical medicine, Randomized controlled trial, law, medicine, Humans, Orthopedics and Sports Medicine, education, Aged, Femoral neck, 030222 orthopedics, education.field_of_study, Hip fracture, femoral neck fracture, business.industry, Bone Cements, revision surgery, 030208 emergency & critical care medicine, General Medicine, medicine.disease, Arthroplasty, Surgery, Treatment Outcome, medicine.anatomical_structure, Female, Hemiarthroplasty, business, Body mass index
Abstract

Objectives HEALTH was a randomized controlled trial comparing total hip arthroplasty with hemiarthroplasty in low-energy displaced femoral neck fracture patients aged ≥50 years with unplanned revision surgery within 24 months of the initial procedure being the primary outcome. No significant short-term differences between treatment arms were observed. The primary objective of this secondary HEALTH trial analysis was to determine if any patient and surgical factors were associated with increased risk of revision surgery within 24 months after hip fracture. Methods We analyzed 9 potential factors chosen a priori that could be associated with revision surgery. The factors included age, body mass index, major comorbidities, independent ambulation, type of surgical approach, length of operation, use of femoral cement, femoral head size, and degree of femoral stem offset. Our statistical analysis was a multivariable Cox regression using reoperation within 24 months of index surgery as the dependent variable. Results Of the 1441 patients included in this analysis, 8.1% (117/1441) experienced reoperation within 24 months. None of the studied factors were found to be predictors of revision surgery (P > 0.05). Conclusion Both total and partial hip replacements are successful procedures in low-energy displaced femoral neck fracture patients. We were unable to identify any patient or surgeon-controlled factors that significantly increased the need for revision surgery in our elderly and predominately female patient population. One should not generalize our findings to an active physiologically younger femoral neck fracture population. Level of evidence Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Published
2020

19. Clockwise torque of sliding hip screws: is there a right side?

Author

Wurdemann, F.S., Poolman, R.W., Krijnen, P., Bzovsky, S., Sprague, S., Kaptein, B.L., Hegeman, J.H., Schemitsch, E.H., Bhandari, M., Swiontkowski, M., Schipper, I.B., Dutch Hip Fracture Audit Grp, FAITH Investigators, and Public Health

Subjects
Bone Screws, sliding hip screw, Dentistry, Logistic regression, biomechanics, Fracture Fixation, Internal, 03 medical and health sciences, 0302 clinical medicine, left, right, medicine, Humans, Orthopedics and Sports Medicine, Clinical significance, Femoral neck, 030222 orthopedics, Hip fracture, femoral neck fracture, Hip Fractures, business.industry, Biomechanics, side, Implant failure, 030208 emergency & critical care medicine, General Medicine, Odds ratio, medicine.disease, Confidence interval, Femoral Neck Fractures, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], medicine.anatomical_structure, Torque, implant failure, clockwise torque, Female, Surgery, business, rotational stability
Abstract

Contains fulltext : 228691.pdf (Publisher’s version ) (Closed access) OBJECTIVES: This study evaluated whether patients with a left-sided femoral neck fracture (FNF) treated with a sliding hip screw (SHS) had a higher implant failure rate than patients treated for a right-sided FNF. This was performed to determine the clinical relevance of the clockwise rotational torque of the femoral neck lag screw in a SHS, in relation to the rotational stability of left and right-sided FNFs after fixation. METHODS: Data were derived from the FAITH trial and Dutch Hip Fracture Audit (DHFA). Patients with a FNF, aged ≥50, treated with a SHS, with at least 3-month follow-up data available, were included. Implant failure was analyzed in a multivariable logistic regression model adjusted for age, sex, fracture displacement, prefracture living setting and functional mobility, and American Society for Anesthesiologists Class. RESULTS: One thousand seven hundred fifty patients were included, of which 944 (53.9%) had a left-sided and 806 (46.1%) a right-sided FNF. Implant failure occurred in 60 cases (3.4%), of which 31 were left-sided and 29 right-sided. No association between fracture side and implant failure was found [odds ratio (OR) for left vs. right 0.89, 95% confidence interval (CI) 0.52-1.52]. Female sex (OR 3.02, CI: 1.62-6.10), using a mobility aid (OR 2.02, CI 1.01-3.96) and a displaced fracture (OR 2.51, CI: 1.44-4.42), were associated with implant failure. CONCLUSIONS: This study could not substantiate the hypothesis that the biomechanics of the clockwise screw rotation of the SHS contributes to an increased risk of implant failure in left-sided FNFs compared with right-sided fractures. LEVEL OF EVIDENCE: Therapeutic Level II.See Instructions for Authors for a complete description of levels of evidence.

Published
2020

20. Predictors of long-term pain after hip arthroplasty in patients with femoral neck fractures

Author

Noori, A., Sprague, S., Bzovsky, S., Schemitsch, E.H., Poolman, R.W., Frihagen, F., Axelrod, D., Heels-Ansdell, D., Bhandari, M., Busse, J.W., and HEALTH Investigators

Subjects
medicine.medical_specialty, Arthroplasty, Replacement, Hip, medicine.medical_treatment, Osteoarthritis, Femoral Neck Fractures, law.invention, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, medicine, Humans, Orthopedics and Sports Medicine, pain, hip arthroplasty, hemiarthroplasty, Aged, Ontario, 030222 orthopedics, Hip fracture, femoral neck fracture, business.industry, Absolute risk reduction, 030208 emergency & critical care medicine, General Medicine, medicine.disease, Arthroplasty, Confidence interval, Treatment Outcome, predictors, Female, Surgery, business, Cohort study
Abstract

Objectives To identify factors associated with the development of prolonged pain after hip fracture surgery. Design Secondary analysis of a randomized controlled trial. Setting Eighty hospitals in 10 countries. Patients/participants One thousand four hundred forty-one hip fracture patients in the HEALTH trial. Interventions Total hip arthroplasty or hemiarthroplasty. Main outcome measures Moderate-to-severe pain (at least 2 activities on the Western Ontario and McMaster Universities Osteoarthritis questionnaire pain subscale with scores ≥2) at 12 and 24 months after hip arthroplasty. Results Of 840 and 726 patients with complete baseline data and outcomes at 1-year and 2-year follow-up, 96 (11.4%) and 80 (11.0%) reported moderate-to-severe pain, respectively. An increased risk of pain at both 1 and 2 years after surgery was associated with reporting moderate-to-severe hip pain before fracture [absolute risk increase (ARI) 15.3%, 95% confidence interval (CI) 6.44%-24.35%; ARI 12.5%, 95% CI 2.85%-22.12%, respectively] and prefracture opioid use (ARI 15.6%, 95% CI 5.41%-25.89%; ARI 21.1%; 95% CI 8.23%-34.02%, respectively). Female sex was associated with an increased risk of persistent pain at 1 year (ARI 6.2%, 95% CI 3.53%-8.84%). A greater risk of persistent pain at 2 years was associated with younger age (≤79-year-old; ARI 6.3%; 95% CI 2.67%-9.91%) and higher prefacture functional status (ARI 10.7%; 95% CI 3.80%-17.64%). Conclusions Among hip fracture patients undergoing arthroplasty, approximately one in 10 will experience moderate-to-severe pain up to 2 years after surgery. Younger age, female sex, higher functioning prefracture, living with hip pain prefracture, and use of prescription opioids were predictive of persistent pain. Level of evidence Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Published
2020

21. What predicts health-related quality of life for patients with displaced femoral neck fractures managed with arthroplasty?

Author

Axelrod, D., Comeau-Gauthier, M., Bzovsky, S., Schemitsch, E.H., Poolman, R.W., Frihagen, F., Guerra-Farfan, E., Heels-Ansdell, D., Bhandari, M., Sprague, S., and HEALTH Investigators

Subjects
medicine.medical_specialty, WOMAC, Arthroplasty, Replacement, Hip, medicine.medical_treatment, Population, Osteoarthritis, Femoral Neck Fractures, femoral neck fractures, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Internal medicine, medicine, Humans, Orthopedics and Sports Medicine, education, Femoral neck, 030222 orthopedics, education.field_of_study, function, business.industry, Repeated measures design, 030208 emergency & critical care medicine, General Medicine, medicine.disease, Arthroplasty, health-related quality of life, Treatment Outcome, medicine.anatomical_structure, Quality of Life, Surgery, Hemiarthroplasty, business
Abstract

BACKGROUND: Total hip arthroplasty (THA) has been argued to improve health-related quality of life (HRQoL) and function in femoral neck fracture patients compared with hemiarthroplasty (HA). The HEALTH trial showed no clinically important functional advantages of THA over HA. The current analysis explores factors associated with HRQoL and function in this population. METHODS: Using repeated measures regression, we estimated the association between HRQoL and function [Short Form-12 (SF-12) physical component score (PCS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score] and 23 variables. RESULTS: THA as compared to monopolar HA, but not bipolar HA, was more likely to improve PCS scores (adjusted mean difference [AMD] 1.88 points, P = 0.02), whereas higher American Society of Anesthesiologists score (AMD -2.64, P < 0.01), preoperative use of an aid (AMD -2.66, P < 0.01), and partial weight-bearing status postoperatively (AMD -1.38, P = 0.04) demonstrated less improvement of PCS scores over time. THA improved WOMAC function scores over time compared with monopolar HA (but not bipolar HA) (AMD -2.40, P < 0.01), whereas higher American Society of Anesthesiologists classification (AMD 1.99, P = 0.01) and preoperative use of an aid (AMD 5.39, P < 0.01) were associated with lower WOMAC function scores. Preoperative treatment for depression was associated with lower functional scores (AMD 7.73, P < 0.01). CONCLUSION: Patients receiving THA are likely to receive small and clinically unimportant improvements in health utility and function compared with those receiving monopolar HA and little improvement compared with those receiving bipolar HA. Patient-specific characteristics seem to play a larger role in predicting functional improvement among femoral neck fracture patients. LEVEL OF EVIDENCE: Prognostic Level II.

Published
2020

22. Arthroplasty versus internal fixation for the treatment of undisplaced femoral neck fractures

Author

Afaq, S., OʼHara, N.N., Schemitsch, E.H., Bzovsky, S., Sprague, S., Poolman, R.W., Frihagen, F., Heels-Ansdell, D., Bhandari, M., Tan, E.C.T.H., Kampen, A. van, Biert, J., Edwards, M.J.R., Frolke, J.P.M., Poelhekke, L.M.S.J., Waal Malefijt, M.C. de, Schreurs, B.W., Swiontkowski, M., and Slobogean, G.P.

Subjects
Male, Reoperation, medicine.medical_specialty, medicine.medical_treatment, Arthroplasty, Replacement, Hip, Femoral Neck Fractures, law.invention, 03 medical and health sciences, Fracture Fixation, Internal, 0302 clinical medicine, Randomized controlled trial, law, medicine, Risk of mortality, internal fixation, Internal fixation, Humans, Orthopedics and Sports Medicine, undisplaced femoral neck fracture, Aged, Retrospective Studies, Aged, 80 and over, 030222 orthopedics, business.industry, Mortality rate, 030208 emergency & critical care medicine, Retrospective cohort study, General Medicine, Odds ratio, Middle Aged, Arthroplasty, Surgery, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10], Treatment Outcome, Quality of Life, arthroplasty, Female, Hemiarthroplasty, business
Abstract

Contains fulltext : 228684.pdf (Publisher’s version ) (Closed access) OBJECTIVE: To compare the 24-month risk of mortality between arthroplasty and internal fixation for undisplaced femoral neck fractures (FNFs). DESIGN: Retrospective cohort study. SETTING: Secondary data analysis of 2 multinational randomized controlled trials. PARTICIPANTS: Patients aged 50 years or older with a FNF. INTERVENTION: Arthroplasty (n = 1441), including total hip arthroplasty and hemiarthroplasty, performed for a displaced FNF versus internal fixation (n = 734), including sliding hip screw or multiple cancellous screws, performed for an undisplaced FNF. MAIN OUTCOME MEASUREMENT: The primary outcome was mortality within 24 months of injury. Secondary outcomes included reoperation and health-related quality of life. RESULTS: The 24-month mortality rate was 15.0% (n = 327). Arthroplasty was associated with a significant reduction in the odds of mortality [adjusted odds ratio (aOR): 0.56, 95% confidence interval (CI): 0.44-0.72, P < 0.01] compared with treatment with internal fixation. 11.4% (n = 248) of the study patients required reoperation within 24 months of injury. The odds of reoperation were 59% lower with arthroplasty treatment than with internal fixation (aOR: 0.41, 95% CI: 0.32-0.55, P < 0.01). The 24-month SF-12 physical component scores were 2.7 points higher in arthroplasty patients compared with internal fixation patients (95% CI: 1.6-3.8, P < 0.01). CONCLUSIONS: Our findings suggest arthroplasty for a FNF may reduce the risk of mortality and reoperation compared with internal fixation of undisplaced fractures. This finding is counter to many current surgical practices but consistent with a mounting body of evidence. Before widespread adoption of arthroplasty for undisplaced fractures, these results should be confirmed in a definitive comparative trial. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Published
2020

23. Factors Associated With Mortality After Surgical Management of Femoral Neck Fractures

Author

Bzovsky, S., Comeau-Gauthier, M., Schemitsch, E.H., Swiontkowski, M., Heels-Ansdell, D., Frihagen, F., Tan, E.C.T.H., Kampen, A. van, Biert, J., Edwards, M.J.R., Frölke, J.P., Poelhekke, L.M.S.J., Waal Malefijt, M.C. de, Bhandari, M., and Sprague, S.

Subjects
medicine.medical_specialty, medicine.medical_treatment, Arthroplasty, Replacement, Hip, Femoral Neck Fractures, 03 medical and health sciences, Fracture Fixation, Internal, 0302 clinical medicine, Risk Factors, Risk of mortality, Medicine, Internal fixation, Humans, Orthopedics and Sports Medicine, Femoral neck, Aged, Retrospective Studies, 030222 orthopedics, Hip fracture, business.industry, Hip Fractures, Mortality rate, 030208 emergency & critical care medicine, General Medicine, medicine.disease, Arthroplasty, Surgery, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], medicine.anatomical_structure, Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10], business, Kidney disease
Abstract

Contains fulltext : 228698.pdf (Publisher’s version ) (Closed access) BACKGROUND: Hip fractures are recognized as one of the most devastating injuries impacting older adults because of the complications that follow. Mortality rates postsurgery can range from 14% to 58% within one year of fracture. We aimed to identify factors associated with increased risk of mortality within 24 months of a femoral neck fracture in patients aged ≥50 years enrolled in the FAITH and HEALTH trials. METHODS: Two multivariable Cox proportional hazards regressions were used to investigate potential prognostic factors that may be associated with mortality within 90 days and 24 months of hip fracture. RESULTS: Ninety-one (4.1%) and 304 (13.5%) of 2247 participants died within 90 days and 24 months of suffering a femoral neck fracture, respectively. Older age (P < 0.001), lower body mass index (P = 0.002), American Society of Anesthesiologists (ASA) class III/IV/V (P = 0.004), use of an ambulatory aid before femoral neck fracture (P < 0.001), and kidney disease (P < 0.001) were associated with a higher risk of mortality within 24 months of femoral neck fracture. Older age (P = 0.03), lower body mass index (P = 0.02), use of an ambulatory aid before femoral neck fracture (P < 0.001), and having a comorbidity (P = 0.04) were associated with a higher risk of mortality within 90 days of femoral neck fracture. CONCLUSIONS: Our analysis found that factors that are indicative of a poorer health status were associated with a higher risk of mortality within 24 months of femoral neck fracture. We did not find a difference in treatment methods (internal fixation vs. joint arthroplasty) on the risk of mortality. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Published
2020

24. Delays in hospital admissions in patients with fractures across 18 low-income and middle-income countries (INORMUS): a prospective observational study

Author

Pouramin P, Li C, Busse J, Sprague S, Devereaux P, Jagnoor J, Ivers R, Bhandari M, and INORMUS Investigators

Abstract

Background The Lancet Commission on Global Surgery established the Three Delays framework, categorising delays in accessing timely surgical care into delays in seeking care (First Delay), reaching care (Second Delay), and receiving care (Third Delay). Globally, knowledge gaps regarding delays for fracture care, and the lack of large prospective studies informed the rationale for our international observational study. We investigated delays in hospital admission as a surrogate for accessing timely fracture care and explored factors associated with delayed hospital admission. Methods In this prospective observational substudy of the ongoing International Orthopaedic Multicenter Study in Fracture Care (INORMUS), we enrolled patients with fracture across 49 hospitals in 18 low-income and middle-income countries, categorised into the regions of China, Africa, India, south and east Asia, and Latin America. Eligible patients were aged 18 years or older and had been admitted to a hospital within 3 months of sustaining an orthopaedic trauma. We collected demographic injury data and time to hospital admission. Our primary outcome was the number of patients with open and closed fractures who were delayed in their admission to a treating hospital. Delays for patients with open fractures were defined as being more than 2 h from the time of injury (in accordance with the Lancet Commission on Global Surgery) and for those with closed fractures as being a delay of more than 24 h. Secondary outcomes were reasons for delay for all patients with either open or closed fractures who were delayed for more than 24 h. We did logistic regression analyses to identify risk factors of delays of more than 2 h in patients with open fractures and delays of more than 24 h in patients with closed fractures. Logistic regressions were adjusted for region, age, employment, urban living, health insurance, interfacility referral, method of transportation, number of fractures, mechanism of injury, and fracture location. We further calculated adjusted relative risk (RR) from adjusted odds ratios, adjusted for the same variables. This study was registered with ClinicalTrials.gov, NCT02150980, and is ongoing. Findings Between April 3, 2014, and May 10, 2019, we enrolled 31 255 patients with fractures, with a median age of 45 years (IQR 31-62), of whom 19 937 (63.8%) were men, and 14 524 (46.5%) had lower limb fractures, making them the most common fractures. Of 5256 patients with open fractures, 3778 (71.9%) were not admitted to hospital within 2 h. Of 25 999 patients with closed fractures, 7141 (27 .5%) were delayed by more than 24 h. Of all regions, Latin America had the greatest proportions of patients with delays (173 [ 88.7%] of 195 patients with open fractures; 426 [44.7%] of 952 with closed fractures). Among patients delayed by more than 24 h, the most common reason for delays were interfacility referrals (3755 [47.7%] of 7875) and Third Delays (cumulatively interfacility referral and delay in emergency department: 3974 [50.5%]), while Second Delays (delays in reaching care) were the least common (423 [5.4%]). Compared with other methods of transportation (eg, walking, rickshaw), ambulances led to delay in transporting patients with open fractures to a treating hospital (adjusted RR 0.66, 99% CI 0.46-0.93). Compared with patients with closed lower limb fractures, patients with closed spine (adjusted RR 2.47, 99% CI 2.17-2.81) and pelvic (1.35, 1.10-1.66) fractures were most likely to have delays of more than 24 h before admission to hospital. Interpretation In low-income and middle-income countries, timely hospital admission remains largely inaccessible, especially among patients with open fractures. Reducing hospital-based delays in receiving care, and, in particular, improving interfacility referral systems are the most substantial tools for reducing delays in admissions to hospital. Copyright (C) 2020 The Author(s). Published by Elsevier Ltd.

Published
2020

25. The FAITH and HEALTH Trials: Are We Studying Different Hip Fracture Patient Populations?

Author

Blankstein, M., Schemitsch, E.H., Bzovsky, S., Axelrod, D., Poolman, R.W., Frihagen, F., Bhandari, M., Swiontkowski, M., Tan, E.C.T.H., Kampen, A. van, Sprague, S., Schottel, P.C., Blankstein, M., Schemitsch, E.H., Bzovsky, S., Axelrod, D., Poolman, R.W., Frihagen, F., Bhandari, M., Swiontkowski, M., Tan, E.C.T.H., Kampen, A. van, Sprague, S., and Schottel, P.C.

Abstract

Contains fulltext : 228739.pdf (Publisher’s version ) (Closed access), BACKGROUND: Over the past decade, 2 randomized controlled trials were performed to evaluate 2 surgical strategies (internal fixation and arthroplasty) for the treatment of low-energy femoral neck fractures in patients aged ≥50 years. We evaluated whether patient populations in both the FAITH and HEALTH trials had different baseline characteristics and compared the displaced femoral neck fracture cohort from the FAITH trial to HEALTH trial patients. METHODS: Patient demographics, medical comorbidities, and fracture characteristics from both trials were compared. FAITH trial patients with displaced fractures were then compared with HEALTH patients. T-tests and χ tests were performed to compare differences for sex, age, osteoporosis status, and ASA class. RESULTS: The mean age of the 1079 FAITH trial patients was 72 versus 79 years for the 1441 HEALTH trial patients. HEALTH patients were older, mostly White, used more medication, and had more comorbidities than FAITH patients. Of the 1079 FAITH trial patients, 32% (346/1079) had displaced fractures. Their mean age was significantly lower than that of HEALTH patients (66 vs. 79 years; P < 0.001). HEALTH trial patients were significantly more likely to be female, have ASA classification Class III/IV/V, and carry a diagnosis of osteoporosis, as compared with the subgroup of FAITH patients with displaced femoral neck fractures (P < 0.001). CONCLUSION: This study demonstrates significant differences between patients enrolled in the 2 trials. Although both studies focused on femoral neck fractures with similar enrollment criteria, patient populations differed. This sheds light on a noteworthy limitation of discordant patient enrollment into randomized trials, despite similar eligibility criteria. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Published
2020

26. Venous Thromboembolism in Hip Fracture Patients: A Subanalysis of the FAITH and HEALTH Trials

Author

MacDonald, D.R.W., Neilly, D., Schneider, P.S., Bzovsky, S., Sprague, S., Axelrod, D., Poolman, R.W., Frihagen, F., Bhandari, M., Swiontkowski, M., Tan, E.C.T.H., Kampen, A. van, Schemitsch, E.H., Stevenson, I.M., MacDonald, D.R.W., Neilly, D., Schneider, P.S., Bzovsky, S., Sprague, S., Axelrod, D., Poolman, R.W., Frihagen, F., Bhandari, M., Swiontkowski, M., Tan, E.C.T.H., Kampen, A. van, Schemitsch, E.H., and Stevenson, I.M.

Abstract

Contains fulltext : 228746.pdf (Publisher’s version ) (Closed access), BACKGROUND: The primary objective of this study was to determine the incidence of symptomatic venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), in the hip fracture population. Secondary objectives included determining timing of VTE diagnosis, VTE thromboprophylaxis given, and identifying any factors associated with VTE. METHODS: Using data from the FAITH and HEALTH trials, the incidence of VTE, including DVT and PE, and the timing of VTE were determined. A multivariable Cox regression analysis was used to determine which factors were associated with increased risk of VTE, including age, treatment for comorbidity, thromboprophylaxis, time to surgery, and method of fracture management. RESULTS: 2520 hip fracture patients were included in the analysis. Sixty-four patients (2.5%) had a VTE [DVT: 36 (1.4%), PE: 28 (1.1%)]. Thirty-five (54.7%) were diagnosed less than 6 weeks postfracture and 29 (45.3%) more than 6 weeks postfracture. One thousand nine hundred ninety-three (79%) patients received thromboprophylaxis preoperatively and 2502 (99%) received thromboprophylaxis postoperatively. The most common method of preoperative (46%) and postoperative (73%) thromboprophylaxis was low molecular weight heparin. Treatment with arthroplasty compared to internal fixation was the only variable associated with increased risk of VTE (hazard ratio 2.67, P = 0.02). CONCLUSIONS: The incidence of symptomatic VTE in hip fracture patients recruited to the 2 trials was 2.5%. Although over half of the cases were diagnosed within 6 weeks of fracture, VTE is still prevalent after this period. The majority of patients received thromboprophylaxis. Treatment with arthroplasty rather than fixation was associated with increased incidence of VTE. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Published
2020

27. Arthroplasty Versus Internal Fixation for the Treatment of Undisplaced Femoral Neck Fractures: A Retrospective Cohort Study

Author

Afaq, S., OʼHara, N.N., Schemitsch, E.H., Bzovsky, S., Sprague, S., Poolman, R.W., Frihagen, F., Heels-Ansdell, D., Bhandari, M., Tan, E.C.T.H., Kampen, A. van, Biert, J., Edwards, M.J.R., Frolke, J.P.M., Poelhekke, L.M.S.J., Waal Malefijt, M.C. de, Schreurs, B.W., Swiontkowski, M., Slobogean, G.P., Afaq, S., OʼHara, N.N., Schemitsch, E.H., Bzovsky, S., Sprague, S., Poolman, R.W., Frihagen, F., Heels-Ansdell, D., Bhandari, M., Tan, E.C.T.H., Kampen, A. van, Biert, J., Edwards, M.J.R., Frolke, J.P.M., Poelhekke, L.M.S.J., Waal Malefijt, M.C. de, Schreurs, B.W., Swiontkowski, M., and Slobogean, G.P.

Abstract

Contains fulltext : 228684.pdf (Publisher’s version ) (Closed access), OBJECTIVE: To compare the 24-month risk of mortality between arthroplasty and internal fixation for undisplaced femoral neck fractures (FNFs). DESIGN: Retrospective cohort study. SETTING: Secondary data analysis of 2 multinational randomized controlled trials. PARTICIPANTS: Patients aged 50 years or older with a FNF. INTERVENTION: Arthroplasty (n = 1441), including total hip arthroplasty and hemiarthroplasty, performed for a displaced FNF versus internal fixation (n = 734), including sliding hip screw or multiple cancellous screws, performed for an undisplaced FNF. MAIN OUTCOME MEASUREMENT: The primary outcome was mortality within 24 months of injury. Secondary outcomes included reoperation and health-related quality of life. RESULTS: The 24-month mortality rate was 15.0% (n = 327). Arthroplasty was associated with a significant reduction in the odds of mortality [adjusted odds ratio (aOR): 0.56, 95% confidence interval (CI): 0.44-0.72, P < 0.01] compared with treatment with internal fixation. 11.4% (n = 248) of the study patients required reoperation within 24 months of injury. The odds of reoperation were 59% lower with arthroplasty treatment than with internal fixation (aOR: 0.41, 95% CI: 0.32-0.55, P < 0.01). The 24-month SF-12 physical component scores were 2.7 points higher in arthroplasty patients compared with internal fixation patients (95% CI: 1.6-3.8, P < 0.01). CONCLUSIONS: Our findings suggest arthroplasty for a FNF may reduce the risk of mortality and reoperation compared with internal fixation of undisplaced fractures. This finding is counter to many current surgical practices but consistent with a mounting body of evidence. Before widespread adoption of arthroplasty for undisplaced fractures, these results should be confirmed in a definitive comparative trial. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Published
2020

28. Delays in hospital admissions in patients with fractures across 18 low-income and middle-income countries (INORMUS): a prospective observational study

Author

Pouramin, P, Li, CS, Busse, JW, Sprague, S, Devereaux, PJ, Jagnoor, J, Ivers, RQ, Bhandari, M, Guyatt, G, Petrisor, B, Thabane, L, Boniface, RL, Browner, B, de la Huerta, F, Miclau, T, Moroz, P, Pollak, A, Slobogean, G, Sancheti, P, Schemitsch, E, Zhou, J, McKay, P, Mundi, R, O'Hara, N, Heels-Ansdell, D, Buckingham, L, Simunovic, N, Norton, R, Zhang, J, Tian, M, Bhaumik, S, Parveen, S, Morshed, S, MacKechnie, MC, Liu, Y, Zhao, Y, Li, J, Zhang, H, Zhang, Z, Zhang, W, Guo, T, Chen, G, Jia, Z, Yang, J, Kang, L, Zhang, P, Ma, H, Liu, D, Ma, Y, Qin, Y, Wang, J, Liu, H, Ma, X, Ma, J, Jia, H, Cui, S, Zhao, Z, Fu, L, Jiang, H, Lv, J, Hu, S, Wang, Y, Sun, M, Tao, S, Qi, B, Gao, M, Wu, B, Zhi, C, Xing, B, Dai, W, Lu, D, He, S, Cai, X, Liu, G, Rui, G, Hu, B, Shi, P, Chen, H, Wang, T, Wang, Q, Xie, L, Xie, H, Mutanda, T, Ntuulo, J, Lubega, F, Tracy, GT, Zaitun, K, Ndayisaba, S, Amone, T, Odong, SR, Lutomia, M, Okatch, C, Bitok, T, Kiambuthi, A, Otsyeno, FMT, Jani, PG, Mutiso, VM, Ating'a, JE, Kilonzo, PK, Pouramin, P, Li, CS, Busse, JW, Sprague, S, Devereaux, PJ, Jagnoor, J, Ivers, RQ, Bhandari, M, Guyatt, G, Petrisor, B, Thabane, L, Boniface, RL, Browner, B, de la Huerta, F, Miclau, T, Moroz, P, Pollak, A, Slobogean, G, Sancheti, P, Schemitsch, E, Zhou, J, McKay, P, Mundi, R, O'Hara, N, Heels-Ansdell, D, Buckingham, L, Simunovic, N, Norton, R, Zhang, J, Tian, M, Bhaumik, S, Parveen, S, Morshed, S, MacKechnie, MC, Liu, Y, Zhao, Y, Li, J, Zhang, H, Zhang, Z, Zhang, W, Guo, T, Chen, G, Jia, Z, Yang, J, Kang, L, Zhang, P, Ma, H, Liu, D, Ma, Y, Qin, Y, Wang, J, Liu, H, Ma, X, Ma, J, Jia, H, Cui, S, Zhao, Z, Fu, L, Jiang, H, Lv, J, Hu, S, Wang, Y, Sun, M, Tao, S, Qi, B, Gao, M, Wu, B, Zhi, C, Xing, B, Dai, W, Lu, D, He, S, Cai, X, Liu, G, Rui, G, Hu, B, Shi, P, Chen, H, Wang, T, Wang, Q, Xie, L, Xie, H, Mutanda, T, Ntuulo, J, Lubega, F, Tracy, GT, Zaitun, K, Ndayisaba, S, Amone, T, Odong, SR, Lutomia, M, Okatch, C, Bitok, T, Kiambuthi, A, Otsyeno, FMT, Jani, PG, Mutiso, VM, Ating'a, JE, and Kilonzo, PK

Abstract

Background: The Lancet Commission on Global Surgery established the Three Delays framework, categorising delays in accessing timely surgical care into delays in seeking care (First Delay), reaching care (Second Delay), and receiving care (Third Delay). Globally, knowledge gaps regarding delays for fracture care, and the lack of large prospective studies informed the rationale for our international observational study. We investigated delays in hospital admission as a surrogate for accessing timely fracture care and explored factors associated with delayed hospital admission. Methods: In this prospective observational substudy of the ongoing International Orthopaedic Multicenter Study in Fracture Care (INORMUS), we enrolled patients with fracture across 49 hospitals in 18 low-income and middle-income countries, categorised into the regions of China, Africa, India, south and east Asia, and Latin America. Eligible patients were aged 18 years or older and had been admitted to a hospital within 3 months of sustaining an orthopaedic trauma. We collected demographic injury data and time to hospital admission. Our primary outcome was the number of patients with open and closed fractures who were delayed in their admission to a treating hospital. Delays for patients with open fractures were defined as being more than 2 h from the time of injury (in accordance with the Lancet Commission on Global Surgery) and for those with closed fractures as being a delay of more than 24 h. Secondary outcomes were reasons for delay for all patients with either open or closed fractures who were delayed for more than 24 h. We did logistic regression analyses to identify risk factors of delays of more than 2 h in patients with open fractures and delays of more than 24 h in patients with closed fractures. Logistic regressions were adjusted for region, age, employment, urban living, health insurance, interfacility referral, method of transportation, number of fractures, mechanism of injury, and

Published
2020

29. Predictors of Medical Serious Adverse Events in Hip Fracture Patients Treated With Arthroplasty

Author

Neilly, D. (David), Macdonald, D.R.W. (David), Sprague, S. (Sheila), Bzovsky, S. (Sofia), Axelrod, D. (Daniel), Poolman, R.W. (Rudolf), Frihagen, F. (Frede), Heels-Ansdell, D. (Diane), Bhandari, M. (Mohit), Schemitsch, E.H. (Emil), Stevenson, I.M. (Iain), Neilly, D. (David), Macdonald, D.R.W. (David), Sprague, S. (Sheila), Bzovsky, S. (Sofia), Axelrod, D. (Daniel), Poolman, R.W. (Rudolf), Frihagen, F. (Frede), Heels-Ansdell, D. (Diane), Bhandari, M. (Mohit), Schemitsch, E.H. (Emil), and Stevenson, I.M. (Iain)

Abstract

AIM: Patients with hip fractures are often frail with multiple comorbidities and at risk of medical serious adverse events (SAEs). We investigated the HEALTH trial patient population to ascertain predictors of SAEs. METHODS: We performed a multivariable Cox regression analysis. Occurrence of SAEs was included as the dependent variable with 31 potential prognostic factors being included as independent variables. RESULTS: One thousand four hundred forty-one patients were included in this analysis. Three hundred seventy (25.6%) patients suffered from an SAE. The most common events were cardiac (38.4%, n = 105), respiratory (20.8%, n = 77), and neurological (14.1%, n = 77). The majority of SAEs (50.8%, n = 188) occurred in the first 90 days after hip fracture with 35.4% occurring in the first 30 days (n = 131). Body mass index (BMI) between 18.5 and 24.9 compared with BMI between 25 and 29.9 [hazard ratio (HR) 1.32, P = 0.03] and receiving a total hip arthroplasty compared with a bipolar hemiarthroplasty (HR 1.36, P = 0.03) were associated with a higher risk of a medical SAE within 24 months of femoral neck fracture. Age (P = 0.09), use of femoral cement (P = 0.59), and use of canal pressurization (P = 0.37) were not associated with a medical SAE. CONCLUSION: Total hip arthroplasty is associated with more SAEs in the immediate postoperative period, and care should be taken in selecting patients for this treatment compared with a hemiarthroplasty. A higher BMI may be protective in hip fracture patients while age alone does not predict SAEs and neither does the use of femoral cement and/or pressurization. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Published
2020
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30. Clockwise Torque of Sliding Hip Screws: Is There a Right Side?

Author

Würdemann, F.S. (Franka), Poolman, R.W. (Rudolf), Krijnen, P. (Pieta), Bzovsky, S. (Sofia), Sprague, S. (Sheila), Kaptein, B.L. (Bart), Hegeman, J.H. (Johannes), Schemitsch, E.H. (Emil), Bhandari, M. (Mohit), Swiontkowski, M.F. (Marc ), Schipper, I.B. (Inger), Würdemann, F.S. (Franka), Poolman, R.W. (Rudolf), Krijnen, P. (Pieta), Bzovsky, S. (Sofia), Sprague, S. (Sheila), Kaptein, B.L. (Bart), Hegeman, J.H. (Johannes), Schemitsch, E.H. (Emil), Bhandari, M. (Mohit), Swiontkowski, M.F. (Marc ), and Schipper, I.B. (Inger)

Abstract

OBJECTIVES: This study evaluated whether patients with a left-sided femoral neck fracture (FNF) treated with a sliding hip screw (SHS) had a higher implant failure rate than patients treated for a right-sided FNF. This was performed to determine the clinical relevance of the clockwise rotational torque of the femoral neck lag screw in a SHS, in relation to the rotational stability of left and right-sided FNFs after fixation. METHODS: Data were derived from the FAITH trial and Dutch Hip Fracture Audit (DHFA). Patients with a FNF, aged ≥50, treated with a SHS, with at least 3-month follow-up data available, were included. Implant failure was analyzed in a multivariable logistic regression model adjusted for age, sex, fracture displacement, prefracture living setting and functional mobility, and American Society for Anesthesiologists Class. RESULTS: One thousand seven hundred fifty patients were included, of which 944 (53.9%) had a left-sided and 806 (46.1%) a right-sided FNF. Implant failure occurred in 60 cases (3.4%), of which 31 were left-sided and 29 right-sided. No association between fracture side and implant failure was found [odds ratio (OR) for left vs. right 0.89, 95% confidence interval (CI) 0.52-1.52]. Female sex (OR 3.02, CI: 1.62-6.10), using a mobility aid (OR 2.02, CI 1.01-3.96) and a displaced fracture (OR 2.51, CI: 1.44-4.42), were associated with implant failure. CONCLUSIONS: This study could not substantiate the hypothesis that the biomechanics of the clockwise screw rotation of the SHS contributes to an increased risk of implant failure in left-sided FNFs compared with right-sided fractures. LEVEL OF EVIDENCE: Therapeutic Level II.See Instructions for Authors for a complete description of levels of evidence.

Published
2020
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31. Factors Associated With Mortality After Surgical Management of Femoral Neck Fractures

Author

Bzovsky, S. (Sofia), Comeau-Gauthier, M. (Marianne), Schemitsch, E.H. (Emil), Swiontkowski, M.F. (Marc ), Heels-Ansdell, D. (Diane), Frihagen, F. (Frede), Bhandari, M. (Mohit), Sprague, S. (Sheila), Bzovsky, S. (Sofia), Comeau-Gauthier, M. (Marianne), Schemitsch, E.H. (Emil), Swiontkowski, M.F. (Marc ), Heels-Ansdell, D. (Diane), Frihagen, F. (Frede), Bhandari, M. (Mohit), and Sprague, S. (Sheila)

Abstract

BACKGROUND: Hip fractures are recognized as one of the most devastating injuries impacting older adults because of the complications that follow. Mortality rates postsurgery can range from 14% to 58% within one year of fracture. We aimed to identify factors associated with increased risk of mortality within 24 months of a femoral neck fracture in patients aged ≥50 years enrolled in the FAITH and HEALTH trials. METHODS: Two multivariable Cox proportional hazards regressions were used to investigate potential prognostic factors that may be associated with mortality within 90 days and 24 months of hip fracture. RESULTS: Ninety-one (4.1%) and 304 (13.5%) of 2247 participants died within 90 days and 24 months of suffering a femoral neck fracture, respectively. Older age (P < 0.001), lower body mass index (P = 0.002), American Society of Anesthesiologists (ASA) class III/IV/V (P = 0.004), use of an ambulatory aid before femoral neck fracture (P < 0.001), and kidney disease (P < 0.001) were associated with a higher risk of mortality within 24 months of femoral neck fracture. Older age (P = 0.03), lower body mass index (P = 0.02), use of an ambulatory aid before femoral neck fracture (P < 0.001), and having a comorbidity (P = 0.04) were associated with a higher risk of mortality within 90 days of femoral neck fracture. CONCLUSIONS: Our analysis found that factors that are indicative of a poorer health status were associated with a higher risk of mortality within 24 months of femoral neck fracture. We did not find a difference in treatment methods (internal fixation vs. joint arthroplasty) on the risk of mortality. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Published
2020
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32. Who Did the Arthroplasty? Hip Fracture Surgery Reoperation Rates are Not Affected by Type of Training-An Analysis of the HEALTH Database

Author

DeAngelis, R.D. (Ryan), Minutillo, G.T. (Gregory), Stein, M.K. (Matthew), Schemitsch, E.H. (Emil), Bzovsky, S. (Sofia), Sprague, S. (Sheila), Bhandari, M. (Mohit), Donegan, D.J. (Derek), Mehta, S. (Samir), DeAngelis, R.D. (Ryan), Minutillo, G.T. (Gregory), Stein, M.K. (Matthew), Schemitsch, E.H. (Emil), Bzovsky, S. (Sofia), Sprague, S. (Sheila), Bhandari, M. (Mohit), Donegan, D.J. (Derek), and Mehta, S. (Samir)

Abstract

OBJECTIVES: This study compares outcomes for patients with displaced femoral neck fractures undergoing hemiarthroplasty (HA) or total hip arthroplasty (THA) by surgeons of different fellowship training. DESIGN: Retrospective review of HEALTH trial data. SETTING: Eighty clinical sites across 10 countries. PATIENTS/PARTICIPANTS: One thousand four hundred forty-one patients ≥50 years with low-energy hip fractures requiring surgical intervention. INTERVENTION: Patients were randomized to either HA or THA groups in the initial data set. Surgeons' fellowship training was ascertained retrospectively, and outcomes were compared. MAIN OUTCOME MEASUREMENTS: The main outcome was an unplanned secondary procedure at 24 months. Secondary outcomes included death, serious adverse events, prosthetic joint infection (PJI), dislocation, discharge disposition, and

Published
2020
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33. Venous Thromboembolism in Hip Fracture Patients: A Subanalysis of the FAITH and HEALTH Trials

Author

Macdonald, D.R.W. (David), Neilly, D. (David), Schneider, P.S. (Prism), Bzovsky, S. (Sofia), Sprague, S. (Sheila), Axelrod, D. (Daniel), Poolman, R.W. (Rudolf), Frihagen, F. (Frede), Bhandari, M. (Mohit), Swiontkowski, M.F. (Marc ), Schemitsch, E.H. (Emil), Stevenson, I.M. (Iain), Macdonald, D.R.W. (David), Neilly, D. (David), Schneider, P.S. (Prism), Bzovsky, S. (Sofia), Sprague, S. (Sheila), Axelrod, D. (Daniel), Poolman, R.W. (Rudolf), Frihagen, F. (Frede), Bhandari, M. (Mohit), Swiontkowski, M.F. (Marc ), Schemitsch, E.H. (Emil), and Stevenson, I.M. (Iain)

Abstract

BACKGROUND: The primary objective of this study was to determine the incidence of symptomatic venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), in the hip fracture population. Secondary objectives included determining timing of VTE diagnosis, VTE thromboprophylaxis given, and identifying any factors associated with VTE. METHODS: Using data from the FAITH and HEALTH trials, the incidence of VTE, including DVT and PE, and the timing of VTE were determined. A multivariable Cox regression analysis was used to determine which factors were associated with increased risk of VTE, including age, treatment for comorbidity, thromboprophylaxis, time to surgery, and method of fracture management. RESULTS: 2520 hip fracture patients were included in the analysis. Sixty-four patients (2.5%) had a VTE [DVT: 36 (1.4%), PE: 28 (1.1%)]. Thirty-five (54.7%) were diagnosed less than 6 weeks postfracture and 29 (45.3%) more than 6 weeks postfracture. One thousand nine hundred ninety-three (79%) patients received thromboprophylaxis preoperatively and 2502 (99%) received thromboprophylaxis postoperatively. The most common method of preoperative (46%) and postoperative (73%) thromboprophylaxis was low molecular weight heparin. Treatment with arthroplasty compared to internal fixation was the only variable associated with increased risk of VTE (hazard ratio 2.67, P = 0.02). CONCLUSIONS: The incidence of symptomatic VTE in hip fracture patients recruited to the 2 trials was 2.5%. Although over half of the cases were diagnosed within 6 weeks of fracture, VTE is still prevalent after this period. The majority of patients received thromboprophylaxis. Treatment with arthroplasty rather than fixation was associated with increased incidence of VTE. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Published
2020
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34. What Predicts Health-Related Quality of Life for Patients With Displaced Femoral Neck Fractures Managed With Arthroplasty? A Secondary Analysis of the HEALTH Trial

Author

Axelrod, D. (Daniel), Comeau-Gauthier, M. (Marianne), Bzovsky, S. (Sofia), Schemitsch, E.H. (Emil), Poolman, R.W. (Rudolf), Frihagen, F. (Frede), Guerra-Farfán, E. (Ernesto), Heels-Ansdell, D. (Diane), Bhandari, M. (Mohit), Sprague, S. (Sheila), Axelrod, D. (Daniel), Comeau-Gauthier, M. (Marianne), Bzovsky, S. (Sofia), Schemitsch, E.H. (Emil), Poolman, R.W. (Rudolf), Frihagen, F. (Frede), Guerra-Farfán, E. (Ernesto), Heels-Ansdell, D. (Diane), Bhandari, M. (Mohit), and Sprague, S. (Sheila)

Abstract

BACKGROUND: Total hip arthroplasty (THA) has been argued to improve health-related quality of life (HRQoL) and function in femoral neck fracture patients compared with hemiarthroplasty (HA). The HEALTH trial showed no clinically important functional advantages of THA over HA. The current analysis explores factors associated with HRQoL and function in this population. METHODS: Using repeated measures regression, we estimated the association between HRQoL and function [Short Form-12 (SF-12) physical component score (PCS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score] and 23 variables. RESULTS: THA as compared to monopolar HA, but not bipolar HA, was more likely to improve PCS scores (adjusted mean difference [AMD] 1.88 points, P = 0.02), whereas higher American Society of Anesthesiologists score (AMD -2.64, P < 0.01), preoperative use of an aid (AMD -2.66, P < 0.01), and partial weight-bearing status postoperatively (AMD -1.38, P = 0.04) demonstrated less improvement of PCS scores over time. THA improved WOMAC function scores over time compared with monopolar HA (but not bipolar HA) (AMD -2.40, P < 0.01), whereas higher American Society of Anesthesiologists classification (AMD 1.99, P = 0.01) and preoperative use of an aid (AMD 5.39, P < 0.01) were associated with lower WOMAC function scores. Preoperative treatment for depression was associated with lower functional sc

Published
2020
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35. Predictors of Long-Term Pain After Hip Arthroplasty in Patients With Femoral Neck Fractures: A Cohort Study

Author

Noori, A. (Atefeh), Sprague, S. (Sheila), Bzovsky, S. (Sofia), Schemitsch, E.H. (Emil), Poolman, R.W. (Rudolf), Frihagen, F. (Frede), Axelrod, D. (Daniel), Heels-Ansdell, D. (Diane), Bhandari, M. (Mohit), Busse, J.W. (Jason), Noori, A. (Atefeh), Sprague, S. (Sheila), Bzovsky, S. (Sofia), Schemitsch, E.H. (Emil), Poolman, R.W. (Rudolf), Frihagen, F. (Frede), Axelrod, D. (Daniel), Heels-Ansdell, D. (Diane), Bhandari, M. (Mohit), and Busse, J.W. (Jason)

Abstract

OBJECTIVES: To identify factors associated with the development of prolonged pain after hip fracture surgery. DESIGN: Secondary analysis of a randomized controlled trial. SETTING: Eighty hospitals in 10 countries. PATIENTS/PARTICIPANTS: One thousand four hundred forty-one hip fracture patients in the HEALTH trial. INTERVENTIONS: Total hip arthroplasty or hemiarthroplasty. MAIN OUTCOME MEASURES: Moderate-to-severe pain (at least 2 activities on the Western Ontario and McMaster Universities Osteoarthritis questionnaire pain subscale with scores ≥2) at 12 and 24 months after hip arthroplasty. RESULTS: Of 840 and 726 patients with complete baseline data and outcomes at 1-year and 2-year follow-up, 96 (11.4%) and 80 (11.0%) reported moderate-to-severe pain, respectively. An increased risk of pain at both 1 and 2 years after surgery was associated with reporting moderate-to-severe hip pain before fracture [absolute risk increase (ARI) 15.3%, 95% confidence interval (CI) 6.44%-24.35%; ARI 12.5%, 95% CI 2.85%-22.12%, respectively] and prefracture opioid use (ARI 15.6%, 95% CI 5.41%-25.89%; ARI 21.1%; 95% CI 8.23%-34.02%, respectively). Female sex was associated with an increased risk of persistent pain at 1 year (ARI 6.2%, 95% CI 3.53%-8.84%). A greater risk of persistent pain at 2 years was associated with younger age (≤79-year-old; ARI 6.3%; 95% CI 2.67%-9.91%) and higher prefacture functional status (ARI 10.7%; 95% CI 3.80%-17.64%). CONCLUSIONS: Among hip fracture patients undergoing arthroplasty, approximately one in 10 will experience moderate-to-severe pain up to 2 years after surgery. Younger age, female sex, higher functioning prefracture, living with hip pain prefracture, and use of prescription opioids were predictive of persistent pain. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Published
2020
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36. Predictors of Loss to Follow-up in Hip Fracture Trials: A Secondary Analysis of the FAITH and HEALTH Trials

Author

Sivaratnam, S. (Surabhi), Comeau-Gauthier, M. (Marianne), Sprague, S. (Sheila), Schemitsch, E.H. (Emil), Poolman, R.W. (Rudolf), Frihagen, F. (Frede), Bhandari, M. (Mohit), Swiontkowski, M.F. (Marc ), Bzovsky, S. (Sofia), Sivaratnam, S. (Surabhi), Comeau-Gauthier, M. (Marianne), Sprague, S. (Sheila), Schemitsch, E.H. (Emil), Poolman, R.W. (Rudolf), Frihagen, F. (Frede), Bhandari, M. (Mohit), Swiontkowski, M.F. (Marc ), and Bzovsky, S. (Sofia)

Abstract

BACKGROUND: Hip fracture trials often suffer substantial loss to follow-up due to difficulties locating and communicating with participants or when participants, or their family members, withdraw their consent. We aimed to determine which factors were associated with being unable to contact FAITH and HEALTH participants for their 24-month follow-up and to also determine which factors were associated with their withdrawal of consent. METHODS: We conducted 2 multivariable logistic regression analyses to determine which factors were predictive of being unable to contact participants at 24 months postfracture and withdrawal of consent within 24 months of their fracture. Results were reported as odds ratios, 95% confidence intervals, and associated P-values. All tests were 2-tailed with alpha = 0.05. RESULTS: We were unable to contact 123 of 2520 participants (4.9%) for their 24-month follow-up visits and 124 (4.9%) withdrew their consent from the trial. Being non-White (P = 0.003), enrolled from a non-European hospital (P < 0.001), and treated with arthroplasty (P < 0.001) were associated with an increased odds of not completing the 24-month follow-up visit. Being enrolled from a hospital in the United States (P = 0.02), from a hospital in Oceania, India, or South Africa (P < 0.001) as compared to a European hospital, and treated with arthroplasty (P < 0.001) were associated with an increased odds of consent withdrawal. DISCUSSION: Certain factors may be predictive of loss to follow-up in hip fracture trials. We suggest that the identification of such factors may be used to inform and improve retention strategies in future orthopaedic hip fracture trials. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Published
2020
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37. What Factors Increase Revision Surgery Risk When Treating Displaced Femoral Neck Fractures With Arthroplasty: A Secondary Analysis of the HEALTH Trial

Author

Blankstein, M. (Michael), Schemitsch, E.H. (Emil), Bzovsky, S. (Sofia), Poolman, R.W. (Rudolf), Frihagen, F. (Frede), Axelrod, D. (Daniel), Heels-Ansdell, D. (Diane), Bhandari, M. (Mohit), Sprague, S. (Sheila), Schottel, P.C. (Patrick), Blankstein, M. (Michael), Schemitsch, E.H. (Emil), Bzovsky, S. (Sofia), Poolman, R.W. (Rudolf), Frihagen, F. (Frede), Axelrod, D. (Daniel), Heels-Ansdell, D. (Diane), Bhandari, M. (Mohit), Sprague, S. (Sheila), and Schottel, P.C. (Patrick)

Abstract

OBJECTIVES: HEALTH was a randomized controlled trial comparing total hip arthroplasty with hemiarthroplasty in low-energy displaced femoral neck fracture patients aged ≥50 years with unplanned revision surgery within 24 months of the initial procedure being the primary outcome. No significant short-term differences between treatment arms were observed. The primary objective of this secondary HEALTH trial analysis was to determine if any patient and surgical factors were associated with increased risk of revision surgery within 24 months after hip fracture. METHODS: We analyzed 9 potential factors chosen a priori that could be associated with revision surgery. The factors included age, body mass index, major comorbidities, independent ambulation, type of surgical approach, length of operation, use of femoral cement, femoral head size, and degree of femoral stem offset. Our statistical analysis was a multivariable Cox regression using reoperation within 24 months of index surgery as the dependent variable. RESULTS: Of the 1441 patients included in this analysis, 8.1% (117/1441) experienced reoperation within 24 months. None of the studied factors were found to be predictors of revision surgery (P > 0.05). CONCLUSION: Both total and partial hip replacements are successful procedures in low-energy displaced femoral neck fracture patients. We were unable to identify any patient or surgeon-controlled factors that significantly increased the need for revision surgery in our elderly and predominately female patient population. One should not generalize our findings to an active physiologically younger femoral neck fracture population. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Published
2020
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38. Arthroplasty Versus Internal Fixation for the Treatment of Undisplaced Femoral Neck Fractures: A Retrospective Cohort Study

Author

Afaq, S. (Shaikh), O'Hara, N.N. (Nathan), Schemitsch, E.H. (Emil), Bzovsky, S. (Sofia), Sprague, S. (Sheila), Poolman, R.W. (Rudolf), Frihagen, F. (Frede), Heels-Ansdell, D. (Diane), Bhandari, M. (Mohit), Swiontkowski, M.F. (Marc ), Slobogean, G.P. (Gerard), Afaq, S. (Shaikh), O'Hara, N.N. (Nathan), Schemitsch, E.H. (Emil), Bzovsky, S. (Sofia), Sprague, S. (Sheila), Poolman, R.W. (Rudolf), Frihagen, F. (Frede), Heels-Ansdell, D. (Diane), Bhandari, M. (Mohit), Swiontkowski, M.F. (Marc ), and Slobogean, G.P. (Gerard)

Abstract

OBJECTIVE: To compare the 24-month risk of mortality between arthroplasty and internal fixation for undisplaced femoral neck fractures (FNFs). DESIGN: Retrospective cohort study. SETTING: Secondary data analysis of 2 multinational randomized controlled trials. PARTICIPANTS: Patients aged 50 years or older with a FNF. INTERVENTION: Arthroplasty (n = 1441), including total hip arthroplasty and hemiarthroplasty, performed for a displaced FNF versus internal fixation (n = 734), including sliding hip screw or multiple cancellous screws, performed for an undisplaced FNF. MAIN OUTCOME MEASUREMENT: The primary outcome was mortality within 24 months of injury. Secondary outcomes included reoperation and health-related quality of life. RESULTS: The 24-month mortality rate was 15.0% (n = 327). Arthroplasty was associated with a significant reduction in the odds of mortality [adjusted odds ratio (aOR): 0.56, 95% confidence interval (CI): 0.44-0.72, P < 0.01] compared with treatment with internal fixation. 11.4% (n = 248) of the study patients required reoperation within 24 months of injury. The odds of reoperation were 59% lower with arthroplasty treatment than with internal fixation (aOR: 0.41, 95% CI: 0.32-0.55, P < 0.01). The 24-month SF-12 physical component scores were 2.7 points higher in arthroplasty patients compared with internal fixation patients (95% CI: 1.6-3.8, P < 0.01). CONCLUSIONS: Our findings suggest arthroplasty for a FNF may reduce the risk of mortality and reoperation compared with internal fixation of undisplaced fractures. This finding is counter to many current surgical practices but consistent with a mounting body of evidence. Before widespread adoption of arthroplasty for undisplaced fractures, these results should be confirmed in a definitive comparative trial. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Published
2020
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39. Predictors of Loss to Follow-up in Hip Fracture Trials: A Secondary Analysis of the FAITH and HEALTH Trials

Author

Sivaratnam, S., Comeau-Gauthier, M., Sprague, S., Schemitsch, E.H., Poolman, R.W., Frihagen, F., Bhandari, M., Tan, E.C.T.H., Kampen, A. van, Edwards, M.J.R., Swiontkowski, M., Bzovsky, S., Sivaratnam, S., Comeau-Gauthier, M., Sprague, S., Schemitsch, E.H., Poolman, R.W., Frihagen, F., Bhandari, M., Tan, E.C.T.H., Kampen, A. van, Edwards, M.J.R., Swiontkowski, M., and Bzovsky, S.

Abstract

Contains fulltext : 228720.pdf (Publisher’s version ) (Closed access), BACKGROUND: Hip fracture trials often suffer substantial loss to follow-up due to difficulties locating and communicating with participants or when participants, or their family members, withdraw their consent. We aimed to determine which factors were associated with being unable to contact FAITH and HEALTH participants for their 24-month follow-up and to also determine which factors were associated with their withdrawal of consent. METHODS: We conducted 2 multivariable logistic regression analyses to determine which factors were predictive of being unable to contact participants at 24 months postfracture and withdrawal of consent within 24 months of their fracture. Results were reported as odds ratios, 95% confidence intervals, and associated P-values. All tests were 2-tailed with alpha = 0.05. RESULTS: We were unable to contact 123 of 2520 participants (4.9%) for their 24-month follow-up visits and 124 (4.9%) withdrew their consent from the trial. Being non-White (P = 0.003), enrolled from a non-European hospital (P < 0.001), and treated with arthroplasty (P < 0.001) were associated with an increased odds of not completing the 24-month follow-up visit. Being enrolled from a hospital in the United States (P = 0.02), from a hospital in Oceania, India, or South Africa (P < 0.001) as compared to a European hospital, and treated with arthroplasty (P < 0.001) were associated with an increased odds of consent withdrawal. DISCUSSION: Certain factors may be predictive of loss to follow-up in hip fracture trials. We suggest that the identification of such factors may be used to inform and improve retention strategies in future orthopaedic hip fracture trials. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Published
2020

40. What predicts health-related quality of life for patients with displaced femoral neck fractures managed with arthroplasty? A secondary analysis of the HEALTH trial

Author

Axelrod, D, Comeau-Gauthier, M, Bzovsky, S, Schemitsch, EH, Poolman, RW, Frihagen, F, Guerra-Farfán, E, Heels-Ansdell, D, Bhandari, M, Sprague, S, Page, Richard, Thomson, Andrew, Williams, Simon, Goyal, Chatar, Bainbridge, David, Angliss, Richard, Miller, Ben, Brown, Graeme, Eng, Kevin, Bowyer, David, Skelley, John, Boyce, Glenn, Watson, Adam, Donovan, Nathan, Beattie, Sally, Cowland, Amanda, Axelrod, D, Comeau-Gauthier, M, Bzovsky, S, Schemitsch, EH, Poolman, RW, Frihagen, F, Guerra-Farfán, E, Heels-Ansdell, D, Bhandari, M, Sprague, S, Page, Richard, Thomson, Andrew, Williams, Simon, Goyal, Chatar, Bainbridge, David, Angliss, Richard, Miller, Ben, Brown, Graeme, Eng, Kevin, Bowyer, David, Skelley, John, Boyce, Glenn, Watson, Adam, Donovan, Nathan, Beattie, Sally, and Cowland, Amanda

Published
2020

45. The Surveillance After Extremity Tumor Surgery (SAFETY) trial: protocol for a pilot study to determine the feasibility of a multi-centre randomised controlled trial

Author

Ghert, M., Bhandari, M., Bozzo, A., Dijkstra, P.D.S., Griffin, A., Grimer, R., Hayden, J., Manherz, A., Masrouha, K., McKay, P., Miller, B., Parasu, N., Puri, A., Randall, R.L., Schneider, P., Sprague, S., Szpakowski, N., Thabane, L., Turcotte, R., Velez, R., Wilson, D., Zbuk, K., Guyatt, G., and SAFETY Investigators

Subjects
medicine.medical_specialty, Lung Neoplasms, Aftercare, Pilot Projects, Disease-Free Survival, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Quality of life, law, Health care, medicine, Protocol, Humans, 030212 general & internal medicine, Research ethics, medicine.diagnostic_test, business.industry, Soft tissue sarcoma, General surgery, pilot study, Extremities, Sarcoma, General Medicine, Health Care Costs, medicine.disease, Patient recruitment, Oncology, 030220 oncology & carcinogenesis, soft tissue sarcoma, surveillance, Feasibility Studies, Radiography, Thoracic, Neoplasm Recurrence, Local, business, Chest radiograph, Tomography, X-Ray Computed, randomised controlled trial, Biomedical sciences, study protocol
Abstract

IntroductionFollowing the treatment of patients with soft tissue sarcomas (STS) that are not metastatic at presentation, the high risk for local and systemic disease recurrence necessitates post-treatment surveillance. Systemic recurrence is most often detected in the lungs. The most appropriate surveillance frequency and modality remain unknown and, as such, clinical practice is highly varied. We plan to assess the feasibility of conducting a multi-centre randomised controlled trial (RCT) that will evaluate the effect on overall 5-year survival of two different surveillance frequencies and imaging modalities in patients with STS who undergo surgical excision with curative intent.Methods and analysisThe Surveillance After Extremity Tumor Surgery trial will be a multi-centre 2×2 factorial RCT. Patients with non-metastatic primary Grade II or III STS treated with excision will be allocated to one of four treatment arms1: chest radiograph (CXR) every 3 months for 2 years2; CXR every 6 months for 2 years3; chest CT every 3 months for 2 years or4 chest CT every 6 months for 2 years. The primary outcome of the pilot study is the feasibility of a definitive RCT based on a combination of feasibility endpoints. Secondary outcomes for the pilot study include the primary outcome of the definitive trial (overall survival), patient-reported outcomes on anxiety, satisfaction and quality of life, local recurrence-free survival, metastasis-free survival, treatment-related complications and net healthcare costs related to surveillance.Ethics and disseminationThis trial received provisional ethics approval from the McMaster/Hamilton Health Sciences Research Ethics Board on 7 August 2019 (Project number 7562). Final ethics approval will be obtained prior to commencing patient recruitment. Once feasibility has been established and the definitive protocol is finalised, the study will transition to the definitive study.Trial registrationNCT03944798; Pre-results.

Published
2019

47. Development of feeds for juvenile Atlantic bluefin tuna (Thunnus thynnus, L): effect of lipid level and source

Author

Betancor, M.B., Ortega-García, A. (Aurelio), de-la-Gándara, F. (Fernando), Sprague, S., Tocher, D.R., and Mourente, G.

Subjects
fish, krill oil, weaning, growth, omega, survival, juvenile nutrition, lipid sources, biochemical composition, bluefin tuna, larval rearing, Thunnus thynnus, artificial diets, Gene expression, biosynthesis, transcription, fish farming, atún rojo
Abstract

In conclusion, the present study suggests that ABT juveniles can be grown on inert extruded dry feeds that result in good fish growth and accumulation of the health-promoting fatty acid DHA. Furthermore, a blend of VO and KO could be used as the dietary lipid source up to a dietary lipid level of 15 % without affecting fish performance. The expression of lipid metabolism genes in ABT liver showed a different response to dietary lipid level/fatty acid profile, consistent with previous data indicating limited n-3 LC-PUFA biosynthetic capability in ABT. However, gene expression showed some differences between the two trials, which highlight how the genetic background of different batches of ABT juveniles could affect the regulation of metabolic gene expression and thus be a factor in weaning success. The expression of antioxidant enzymes was also altered by diet, related to dietary contents of antioxidant nutrients. Thus, further studies are required in order to fully elucidate the lipid and fatty acid requirements of this iconic species in relation to dietary sources and production costs

Published
2019

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