Search

Background: Ankle replacement and ankle arthrodesis are standard treatments for treating end-stage ankle arthritis when conservative treatment fails. Comparing patient-reported outcome scores to the instrument’s minimal important difference (MID) helps physicians and researchers infer whether a meaningful change in health from the patient’s perspective has occurred following treatment. The objective of this study was to estimate the MID of the Ankle Osteoarthritis Scale among a cohort of operatively treated end-stage ankle arthritis patients undergoing ankle replacement or arthrodesis. Methods: A survey package including the Ankle Osteoarthritis Scale was completed by participants preoperatively and 2 years postoperatively. Distribution and anchor-based approaches to calculating the MID were used to estimate the MID of the Ankle Osteoarthritis Scale and its 2 domains. The distribution-based approaches used were the small and medium effect size methods, while the mean absolute change method and linear regression method were the anchor-based approaches. Bootstrap sampling was used to obtain the variance of MID estimates. The MID was estimated for sex, age, operative, and baseline health subgroups. The cohort comprised 283 participants, totaling 298 ankles. Results: The MID did not vary with sex or operative procedure. Age-based differences in MID values may exist for the Ankle Osteoarthritis Scale total score, and MID values were generally smallest among the oldest patients. Patients with the best and worst ankle-related health preoperatively had higher MID values than patients reporting mid-range Ankle Osteoarthritis Scale values preoperatively. Conclusion: The best estimate of the MID of the Ankle Osteoarthritis Scale total score is 5.81. Our findings indicate that the MID of the Ankle Osteoarthritis Scale may not vary by sex or operative subgroups but likely varies by age and preoperative Ankle Osteoarthritis Scale score. Level of Evidence: Level II, prospective comparative study.

Background: Peripheral nerve blocks (PNBs) have revolutionized distal extremity surgery reducing pain and improving hospital efficiency. Perineural dexamethasone has been administered with PNBs to prolong their effects, although the safety of dexamethasone has not been established in the literature. This study aimed to determine if the addition of dexamethasone affected the postoperative neurological sensory status for foot and ankle surgeries and the recovery of nerve injuries. We hypothesized that the rate of persistent nerve injury would be higher in the dexamethasone group. Methods: This is a retrospective observational cohort study of prospectively collected data of all patients from a single foot and ankle surgeon’s practice. Perineural dexamethasone was routinely used as an adjunct by the regional anesthesia group until a clinical trend of increased paresthesia was found on short-term follow-up, which led to the discontinuation of its use. In this study, the cohort that received dexamethasone with ropivacaine was compared with the cohort that received ropivacaine alone. The primary outcome was a separate sensory nerve status sheet that was completed for every distal nerve territory for every patient at their follow-up visits at 2 weeks, 6 weeks, 3 months, and 6 months. Univariate analysis and a logistic regression model were used to determine the association between dexamethasone and delayed nerve recovery. A total of 250 patients were included in the study, with 117 patients in the dexamethasone group and 133 in the ropivacaine-only group. Results: The rates of nerve injuries were not different between the groups (72 [62%] in the dexamethasone group vs 79 [59%] in the ropivacaine-only group). However, nerve injury symptoms were more likely to persist and not fully recover in the dexamethasone group ( n = 47, 65%) compared with the ropivacaine-only group ( n = 32, 41%) (OR, 2.12; P = .006). Conclusion: Perineural dexamethasone added to PNBs may be associated with delayed nerve recovery after foot and ankle surgery. It may be prudent to avoid its use until its full safety profile is established in larger prospective trials. Level of Evidence: Level III, retrospective comparative study.

Background: The operative procedure for a total ankle replacement (TAR) is intimately associated with the prosthetic design. The anterior and lateral approaches both have pros and cons regarding their respective soft tissue complications, osteotomy requirements, orientation of the bone cut, and gutter visualization. Although both have been studied independently, few reports have compared both in the same setting. The purpose of this retrospective study was to investigate the difference in reoperation rate after lateral or anterior approach ankle arthroplasty. We hypothesized that the anterior approach had a higher rate of wound complications. Methods: We evaluated data from a single center collected between 2014 and 2017, comprising a total of 115 total ankle replacements performed by 1 of 4 fellowship-trained foot and ankle surgeons. Reoperations were recorded as an operative report with classification by Canadian Orthopaedic Foot and Ankle Society (COFAS) Reoperations Coding System (CROCS). The index approach used was determined by the surgeon’s practice preference. Patients were included when they had a primary TAR in the time frame noted and had a complete data set up to at least 2 years after surgery. The cohort comprised 67 anterior and 48 lateral operations with balanced demographics for age (95% CI: 63-67 years) and gender (47% F). The lateral group had more complex cases with higher COFAS type arthritis (more periarticular arthritis and surrounding deformity). Results: Comparing the 2 groups, a total of 40 reoperations (7 anterior [A], 33 lateral [L]) occurred in 27 patients (5 A, 22 L). One patient had 4 related reoperations. The only revision was in the anterior group. The only soft tissue reconstruction was a split-thickness skin graft in the lateral group. Nine reoperations were irrigation debridement related to an infection or wound complication (3 A, 6 L). The majority (19/33) of reoperations in the lateral group were gutter debridement (8) or lateral hardware removal (11). Operative time was statistically different at 145 minutes (95% CI: 127-164 minutes) in anterior TAR and 178 minutes (95% CI: 154-202 minutes) for lateral TAR ( P = .0058). The odds ratio of having any reoperation with a lateral approach TAR was 6.19 compared to the anterior group. Conclusion: The results at the 2-year time point demonstrated that there were more reoperations after a lateral approach TAR than an anterior TAR, recognizing the significant case complexity imbalance between the groups and a corresponding relative increase in resource utilization of lateral TAR patients. The 2 implant designs were associated with different reoperation rates, favoring the anterior group. Change in the lateral fixation may have reduced the risk of repeat surgery. Level of Evidence: Level III, retrospective comparative series.

Background: The use of patient-specific instrumentation (PSI) in modern total ankle replacement (TAR) has augmented positioning of the tibial component, eliminating the need for complex jigs. Coronal and sagittal alignment are intuitive with this design and have been studied, but axial rotation has not. The purpose of this study was to assess the relationship between the planned preoperative axial rotation as set by the PSI guide and the rotation determined intraoperatively with non-PSI instrumentation. Methods: This was a prospective cohort study of 22 consecutive cases. The axial rotation angle between the medial gutter and the tibial implant position on the preoperative CT-scan based plan was extracted. At the time of surgery, the medial gutter alignment instrument from the non-PSI instrumentation was inserted and an intraoperative axial photograph obtained to record the angle between the medial gutter and the axial rotation guide pins set by the PSI instrumentation. The 2 measurements were compared and further statistical analysis included Pearson correlation and paired Student t test. Results: The average axial rotation angle between the medial gutter and the implant on the PSI preoperative plan was 5.4 ± 2.9 degrees, whereas the intraoperative photograph from the medial gutter alignment instrument to the pin was 5.9 ±3.8 degrees. This demonstrated a Pearson correlation of R = 0.54 and a P value of .53. The average difference between the two was −0.46 (95% CI: –2.04, 1.10), meaning that components were either slightly externally rotated or that the fork was aimed internally. Based on this group, 50% (11/22) were within 2 degrees of the target and 77% (17/22) were within 4 degrees of the target. Conclusion: Patient-specific guides allowed for reproducible rotational tibial component implantation in modern TAR. Further work is needed to better understand the biomechanical effects of the rotational profile and consequences on survivorship. Level of Evidence: Level IV, case series.

Background:There is little research investigating which aspects of health-related quality of life change following ankle arthrodesis and total ankle replacement surgery. The objective of this study was to report on statistically and clinically relevant changes in multiple dimensions of health-related quality of life among patients undergoing ankle replacement or fusion surgery.Methods:This study was based on a prospective sample of ankle arthrodesis and total ankle replacement patients. Participants complete the Ankle Osteoarthritis Scale, EuroQoL’s EQ-5D-3L, the Patient Health Questionnaire–9, and the pain intensity, interference with enjoyment of life, and general activity pain instrument. Instruments were completed preoperatively and postoperatively. Multivariate regression models were used to measure the change in health-related quality of life outcomes, adjusting for demographic, clinical, and health service utilization.Results:Participants achieved statistically significant improvements in health-related quality of life in each domain of measurement. The majority of participants reported clinically significant improvement in pain. Mild depressive symptoms were common, and clinically significant improvement in depression symptoms occurred in 22% of patients. Gains in health were more pronounced among participants reporting the worst preoperative health in all domains quality of life measured.Conclusions:Pain showed a clinically important improvement among 64% of participants whereas 22% reported a clinically meaningful improvement in their depression symptoms postoperatively. Clinically significant gains in health-related quality of life were not experienced by all participants in all dimensions. Further research is warranted to better understand the failure of some patients to improve in dimensions of health studied.Level of Evidence:Level III, comparative study.

Background: Total ankle arthroplasty (TAA) is an increasingly selected treatment for end-stage ankle arthritis; however, failure and revision of the tibial and talar components remains an issue. Although multiple risk factors have been shown to contribute to early component revision, no study has looked at combining such risk factors into a predictive model that could potentially decrease revision rates and improve implant survival. This study aimed to develop a predictive model for TAA failure based on patient characteristics, patient-reported outcomes (PROs), and immediate postoperative radiographs. Methods: A retrospective review of a single-site ankle arthritis database was conducted. All patients with current-generation ankle replacements including the Hintegra and Infinity prostheses implanted between 2004 and 2015 and with complete postoperative radiographs taken between 6 and 12 weeks postoperatively were included. Eight coronal and sagittal radiographic parameters were assessed and performed twice by 2 independent orthopedic surgeons on included TAAs. These radiographic parameters were then analyzed in association with patient demographics and PRO. Advanced statistical methods including survival analysis were used to construct a predictive model for TAA survival. A total of 107 patients were included and analyzed with a median clinical follow-up of 49 months (minimum 24 months). Results: A predictive model was created, with 4 parameters identified as being statistically associated with TAA metal-component revision: diabetes mellitus, poor baseline Ankle Osteoarthritis Scale (AOS) score, excessively dorsiflexed talar component, and an anteriorly/posteriorly translated talus relative to the tibial axis. The presence of 3 parameters predicted TAA survival of 0.60 whereas presence of all 4 parameters predicted survival of only 0.13 in the period studied. Conclusion: Our predictive model is based on a combination of patient factors, PROs, and radiographic TAA alignment. We believe it can be used by surgeons to predict failure in their TAA patients, thereby optimizing postoperative outcomes by improving patient selection and modifiable outcome-specific parameters. Level of Evidence: Level III, retrospective cohort study using prospectively collected data.

Background:Restoration of ankle alignment is important in total ankle arthroplasty (TAA), but sagittal alignment of the talar component is less studied than coronal sagittal. Little has been published on the importance of sagittal talar alignment in TAA. The radiographic talar component inclination was hypothesized to be predictive of TAA survival, subsidence, and functional outcomes.Methods:A retrospective review of the Vancouver End-Stage Ankle Arthritis Database was performed on all TAAs at a single center over 11 years utilizing 1 of 2 implants. Talar component inclination (TCI) angles were measured and standard descriptive statistics were completed with a survival analysis. Inter- and intraobserver reliability were determined. Postoperative TCI angles were analyzed against several definitions of TAA survival and patient-reported outcome measures from the database. A total of 109 TAAs satisfied inclusion and exclusion criteria.Results:A postoperative talar component inclination angle greater than 22 degrees was associated with talar component anterior subsidence, defined as a change in that angle of 5 degrees or more between postoperative and last available radiographs. This was still significant after adjusting for confounders: age, gender, body mass index, and presence of inflammatory arthritis. All measured angles had good inter- and intraobserver reliability.Conclusion:Surgeons should avoid dorsiflexing the talar prosthesis during TAA, which hypothetically diminishes the ankle critical dorsiflexion range. This may cause anterior talar undercoverage in terminal dorsiflexion and may edge load the talar prosthesis, predisposing to anterior subsidence. Elevated TCI was a simple and reliable radiographic measurement to predict long-term TAA outcome due to predictable anterior subsidence of the talar prosthesis.Level of Evidence:Level III, retrospective comparative series.

Background: Patient-reported outcomes are increasingly used as measures of effectiveness of interventions. To make the tools more useful, therapeutic thresholds known as minimally important differences have been developed. The objective of this study was to calculate minimally important differences for the domains of the Foot and Ankle Outcome Score for hallux valgus surgery. Methods: The study was based on a retrospective analysis of patients newly scheduled for bunion correction surgery and completing patient-reported outcomes between October 2013 and January 2018. This study used anchor- and distribution-based approaches to calculate the minimally important difference for the instrument’s 5 domains. Confidence intervals were calculated for each approach. There were 91 participants included in the study. Results: Using anchor- and distribution-based approaches, the minimally important difference for the pain domain ranged from 5.8 to 10.2, from 0.3 to 6.9 for the symptoms domain, 8.3 to 10.3 for the activities of daily living domain, 7.4 to 11.1 for the quality of life domain, and from 7.0 to 15.7 for the sports and recreation domain. Small differences in the activities of daily living domain may be more clinically important for patients with better function. Discussion: The range of minimally important difference values for each domain indicate how the Foot and Ankle Outcome Score corresponded to bunion correction surgery. The sports and recreation domain showed considerable variability in the range of values and may be associated with the domain’s lack of responsiveness. Overall, most minimally important difference values for the domains of FAOS ranged from above 4 to below 16. Level of Evidence: Level III, retrospective comparative series.

Background: Bunion correction surgery is a very common procedure to improve patients’ pain and physical function attributable to a misaligned first metatarsophalangeal joint. The objective of this study was to apply a health utility framework to estimate the cost utility of bunion correction surgery. Methods: Patients were prospectively recruited from the population of patients seen in a lower-extremity orthopedic clinic and scheduled for isolated bunion surgery. Participants completed EuroQoL’s EQ-5D(3L) to measure patients’ current general health preoperatively and 6 months postoperatively. Participants’ change in quality-adjusted life years (QALYs) were calculated by comparing the difference between postoperative utility values and preoperative utility values. The study had 95 patients representing 53% of eligible patients. Results: The mean preoperative utility value was 0.6816 and the mean postoperative value was 0.7451, a statistically significant difference denoting an improvement in self-reported health. The cost per QALY, assuming gains in health accrued for 15 years, was $4911 (the 95% confidence interval ranged from $4736 to $5088). The cost per QALY was highest among the oldest patients. Assuming gains in health accrued for 20 years, the cost per QALY was $3922. Conclusion: This study demonstrated that bunion correction surgery was inexpensive relative to its gains in health compared with commonly applied thresholds for women and men in all age groups, though the gains were not uniformly distributed across age categories. Future research should examine the impact of recurrence on the robustness of these findings. Level of Evidence: Level III, comparative study.

Background:Many patients with hallux valgus progress to experiencing pain and loss of function that requires corrective surgery when nonoperative treatments fail. The primary goal of this study was to measure changes in participants’ health while patients waited for their operative correction.Methods:Patients were prospectively recruited to complete a number of patient-reported outcome measures preoperatively. Baseline data collection was initiated in October 2014, and participants’ second surveys were returned by August 2017. The setting of the study was Vancouver, Canada. There were 80 participants in the study. The participation rate among eligible patients was 52.7%.Results:The average wait time for surgery exceeded 8 months, with a mean wait of 35.7 weeks. Baseline pain among participants was high. Only in the domain of foot- and ankle-related quality of life was the duration of wait time associated with participants’ change in health. The other 4 domains of foot function remained stable over the preoperative period.Conclusion:Preoperative health in this study was consistent with other research showing high pain and compromised foot function among patients failing nonoperative therapies for treatment of hallux valgus. This study found high pain and compromised foot function among patients waiting for hallux valgus surgery but only minor relationships between participants’ duration of wait time for operative correction of the first metatarsophalangeal joint and changes in patient-reported outcome scores.Level of Evidence:Level III, comparative study.

Background: People who are affected by end-stage ankle arthritis are as disabled as those suffering from arthritis in other main articulations of the lower extremity. Once these patients become unable to perform their job duties, they leave the workforce and require financial aid from government agencies, which represents a considerable economic burden. Regardless of whether arthrodesis or arthroplasty is performed, we hypothesized that patients younger than 55 years at the time of surgery should be able to return to work within 2 years and require less social assistance. Methods: Patients from 2002 to 2014 included in the nationwide prospective Ankle Reconstruction Database treated for end-stage ankle arthritis with a total ankle replacement or an ankle arthrodesis and younger than 55 years at the time of surgery were included. This study used a standard preoperative survey (AAOS, SF-36) along with the same survey filled by patients in intervals up to 2 years postoperatively. Their employment status was determined at each time point. Participation in third-party wage assistance programs was recorded. This cohort had 194 patients with an average age of 47.0 ± 7.2 years and was balanced in terms of sex (104 female) and side (94 left). Results: The employment rate prior to surgery was 56%, which increased to 62% at the 2-year postoperative mark. With regards to worker’s compensation, disability, and social security, 20% of patients left all subsidized programs whereas 4% entered at least 1 which is significant (P < .05). Conclusion: The 2-year follow-up after tibiotalar arthrodesis/arthroplasty in patients younger than 55 years showed that significantly more people were able to leave subsidized work assistance programs than enroll in them. Level of Evidence: Level II, prospective comparative study.

INTRODUCTION Coronal deformity is considered a relative contraindication for arthroscopic ankle fusion. This study assessed whether preoperative coronal ankle joint deformity influenced the outcome of arthroscopic ankle fusion. METHODS Ninety-seven patients had 62 arthroscopic and 35 open ankle fusions between 2005 and 2012. Clinical outcomes were prospectively recorded with use of the Ankle Osteoarthritis Scale (AOS) and Ankle Arthritis Scale (AAS) preoperatively and at 6, 12, and 24 months and final follow-up. Radiological alignment was measured using the tibiotalar angle, the tibial plafond angle, the lateral talar station, and the lateral tibiotalar angle. Both groups had the same demographics. RESULTS Preoperative deformity was the same regarding sagittal alignment and overall coronal alignment, but the arthroscopic group had less tibial deformity (tibial plafond angle range 0-19 degrees vs 0-43 degrees). At final follow-up, the mean AOS was 34.2 for arthroscopic (95% confidence interval [CI], 23.3-45.2) vs 33.9 for open (95% CI, 17.8-49.9). The AAS at final follow-up was 26.0 for arthroscopic (95% CI, 21.0-31.0) vs 27.5 for open (95% CI, 19.7-35.2). Both groups had the same tibiotalar angle, lateral talar station, and lateral tibiotalar angle at follow-up. Regression analyses revealed no influence of type of surgery, preoperative deformity, postoperative radiological alignment, age, sex, body mass index, smoking status, etiology of the arthritis, and need for bone grafting on outcome scores (all P > .05). CONCLUSION Arthroscopic and open ankle fusion yielded equivalent results for both patient-reported outcome measure and radiographic alignment in patients with coronal and sagittal joint deformity. Patients with higher tibial plafond angles more often underwent open fusion. LEVEL OF EVIDENCE III, comparative series.

We evaluated data from a clinical trial of first metatarsophalangeal joint (MTPJ1) implant hemiarthroplasty and arthrodesis to determine the association between patient factors and clinical outcomes.Patients ≥18 years with hallux rigidus grade 2, 3, or 4 were treated with synthetic cartilage implant MTPJ1 hemiarthroplasty or arthrodesis. Pain visual analog scale (VAS), Foot and Ankle Ability Measure (FAAM) sports and activities of daily living (ADL) scores, and Short Form-36 Physical Function (SF-36 PF) subscore were obtained preoperatively, and at 2, 6, 12, 24, 52, and 104 weeks postoperatively. Final outcome data, great toe active dorsiflexion motion, secondary procedures, radiographs, and safety parameters were evaluated for 129 implant hemiarthroplasties and 47 arthrodeses. The composite primary endpoint criteria for clinical success included VAS pain reduction ≥30%, maintenance/improvement in function, no radiographic complications, and no secondary surgical intervention at 24 months. Predictor variables included hallux rigidus grade; gender; age; body mass index (BMI); symptom duration; prior MTPJ1 surgery; preoperative hallux valgus angle, range of motion (ROM), and pain. Two-sided Fisher exact test was used ( P.05).Patient demographics and baseline outcome measures were similar. Success rates between implant MTPJ1 hemiarthroplasty and arthrodesis were similar ( P.05) when stratified by hallux rigidus grade, gender, age, BMI, symptom duration, prior MTPJ1 surgery status, and preoperative VAS pain, hallux valgus, and ROM.Synthetic cartilage implant hemiarthroplasty was appropriate for patients with grade 2, 3, or 4 hallux rigidus. Its results in those with associated mild hallux valgus (≤20 degrees) or substantial preoperative stiffness were equivalent to MTPJ1 fusion, irrespective of gender, age, BMI, hallux rigidus grade, preoperative pain or symptom duration.Level II, randomized clinical trial.

Foot and ankle surgeons are increasingly relying on patient-reported outcome measures (PROMs) such as the Ankle Osteoarthritis Scale (AOS) to evaluate treatment options. The objectives of this retrospective cohort study were 2-fold: (1) to examine the AOS instrument using psychometric analysis and (2) to revise the questions on the AOS to improve the effect of questions on the score and remove redundancies.Pre- and postoperative patient scores were obtained from AOS questionnaires in the COFAS Prospective Ankle Reconstruction Database, a cohort of patients operatively treated for end-stage ankle arthritis. A split-sample approach was used to evaluate the AOS and to propose a revised instrument.A total of 380 patients who had been treated with total ankle replacement or ankle arthrodesis were prospectively followed to the 2-year postoperative time point. Correlation analysis demonstrated that a number of questions on the AOS were highly correlated with other similar questions, frequently incomplete, or showed little variation between respondents. Eight of the original AOS questions were retained in the newly proposed Ankle Arthritis Score (AAS) [3 from the AOS Pain subscale and 5 from the AOS Disability subscale]. Principal components analysis (PCA) showed that these questions equally clustered into 2 domains in AAS: Basic Activity and Advanced Activity.The AAS is shorter and has improved psychometric properties as compared to the AOS. Further investigation is required to better characterize the clinical utility of this proposed new patient-reported outcome score.Level III, retrospective cohort study.

Background: Repeated surgery can be a measure of failure of the primary surgery. Future reoperations might be avoided if the cause is recognized and procedures or devices modified accordingly. Reoperations result in costs to both patient and the health care system. This paper proposes a new classification system for reoperations in end-stage ankle arthritis, and analyzes reoperation rates for ankle joint replacement and arthrodesis surgeries from a multicenter database. Methods: A total of 213 ankle arthrodeses and 474 total ankle replacements were prospectively followed from 2002 to 2010. Reoperations were identified as part of the prospective cohort study. Operating reports were reviewed, and each reoperation was coded. To verify inter- and intraobserver reliability of this new coding system, 6 surgeons experienced in foot and ankle surgery were asked to assign a specific code to 62 blinded reoperations, on 2 separate occasions. Reliability was determined using intraclass correlation coefficients (ICCs) and proportions of agreement. Results: Of a total of 687 procedures, 74.8% (514/687) required no reoperation (Code 1). By surgery type, 14.1% (30/213) of ankle arthrodesis procedures and 30.2% (143/474) of ankle replacement procedures required reoperation. The rate for reoperations surrounding the ankle joint (ie, Codes 2 and 3) was 9.9% (21/213) for ankle arthrodesis versus 5.9% for ankle replacement (28/474). Reoperation rates within the ankle joint (ie, Codes 4 to 10) were 4.7% (10/213) for ankle arthrodesis and 26.1% (124/474) for ankle replacement. Overall, 0.9% (2/213) of arthrodesis procedures required reoperation outside the initial operative site (Code 3), versus 4.6% (22/474) for total ankle replacement. The rate of reoperation due to deep infection (Code 7) was 0.9% (2/213) for arthrodesis versus 2.3% (11/474) for ankle replacement. Interobserver reliability testing produced a mean ICC of 0.89 on the first read. The mean ICC for intraobserver reliability was 0.92. For interobserver, there was 87.9% agreement (804/915) on the first read, and 87.5% agreement (801/915) on the second. For the intra observer readings, 88.5% (324/366) were in agreement. Conclusions: The new coding system presented here was reliable and may provide a more standardized, clinically useful framework for assessing reoperation rates and resource utilization than prior complication- and diagnosis-based classification systems, such as modifications of the Clavien Dindo System. Analyzing reoperations at the primary site may enable a better understanding of reasons for failure, and may therefore improve the outcomes of surgery in the future. Level of Evidence: Level III, retrospective comparative cohort study based on prospectively collected data.

Background: Systems for classifying complications have been proposed for many surgical subspecialties. The goal of this systematic review was to analyze the number and frequency of different terms used to identify complications in total ankle arthroplasty. We hypothesized that this terminology would be highly variable, supporting a need for a standardized system of reporting. Methods: Studies that met predefined inclusion/exclusion criteria were analyzed to identify terminology used to describe adverse events. All terms were then tabulated and quantified with regard to diversity and frequency of use across all included studies. Terms were also grouped into 10 categories, and the number of reported occurrences of each adverse event was calculated. A reporting tool was then developed. Results: Of 572 unique terms used to describe adverse outcomes in 117 studies, 55.9% (320/572) were used in only a single study. The category that was most frequently reported was revision surgery, with 86% of papers reporting on this event using 115 different terms. Other categories included “additional non-revision surgeries” (74% of papers, 93 terms), “loosening/osteolysis” (63% of papers, 86 terms), “fractures” (60% of papers, 53 terms), “wound problems” (52% of papers, 27 terms), “infection” (52% of papers, 27 terms), “implant problems” (50% of papers, 57 terms), “soft tissue injuries” (31% of papers, 30 terms), “heterotopic ossification” (22% of papers, 17 terms), and “pain” (18% of papers, 11 terms). Conclusion: The reporting of complications and adverse outcomes for total ankle arthroplasty was highly variable. This lack of consistency impedes the accurate reporting and interpretation of data required for the development of cohesive, evidence-based treatment guidelines for end-stage ankle arthritis. Standardized reporting tools are urgently needed. This study presents a prototype worksheet for the standardized assessment and reporting of adverse events. Level of Evidence: Level-III, decision analyses, systematic review of Level III studies and above.

Background:Nonunion risk factor identification and modification are subjective. We describe and validate a predictive nonunion risk factor model to identify foot and ankle operative patients at risk for nonunion.Materials and Methods:One hundred international experts in foot and ankle surgery were surveyed. Nineteen nonunion risk factors were stratified into 3 categories: more significant than, as significant as, and less significant than smoking 1 pack per day. A nonunion risk assessment model was developed by assigning a weighted score to each risk factor, based on its mean score from the survey. A total nonunion risk (TNR) score was calculated for individual patients. It was retrospectively validated in 2 patient cohorts from a single center’s prospectively collected end-stage ankle arthritis patient database: 22 cases of ankle and/or hindfoot fusion nonunion and 40 sex- and procedure-matched controls with bony fusion. Analyses included descriptive statistics, logistic regression, and univariate and multivariate linear regression models.Results:The mean TNR score was 6.6 ± 5.6 in controls and 13.5 ± 8.2 in the nonunion group ( P < .001). Data showed excellent intraobserver and interobserver correlation coefficients. In a logistic regression model, the risk of nonunion exceeded 9% with a TNR score greater than or equal to 10. Multivariate linear regression analysis, adjusted for age and sex, suggested that lack of fusion site stability and obesity (body mass index greater than 30) were significantly predictive of nonunion.Conclusion:The nonunion risk assessment model provides a reliable, sensitive, and specific method for predicting nonunion based on objective patient assessment. Orthopaedic patients at risk for nonunion could benefit from targeted intervention.Level of Evidence:Level IV, retrospective observational study.

Background: Total hip and knee arthroplasty (THA and TKA) are accessible to patients with end-stage hip and knee arthritis in most health care systems. The availability of total ankle arthroplasty (TAA) to patients with end-stage ankle arthritis is often restricted because of prosthesis cost. Ankle fusion (AF) is often offered as the only alternative. Patients should have equal access to procedures that are equivalent in total cost. We compared total costs of TAA, AF, THA, and TKA for similar cohorts in a government-funded teaching hospital. Methods: A subset of 13 TAA and 13 AF patients were selected from the Canadian Orthopaedic Foot and Ankle Society Prospective Ankle Reconstruction Database, and 13 THA and 13 TKA patients were randomly selected from the Canadian Joint Replacement Registry. Total cost was estimated from operating room time, hospital stay, surgeon billing, and equipment used. Results: Mean total cost associated with TAA was $13,500 ± 1000 and was the same as THA ($14,500 ± 1500) and TKA ($12,500 ± 1000). Mean total cost associated with AF was significantly less at $5500 ± 500. Mean operating room time was longer, but mean hospital stay was shorter for the ankle procedures compared with THA and TKA. Conclusion: All arthroplasties had similar total costs. Total ankle arthroplasty should not be denied based on prosthetic cost alone, as total procedure cost is equivalent to THA and TKA. We believe ankle fusion is a less expensive and preferable alternative for some patient groups. Level of Evidence: Level II, comparative series.

Background: Limb occlusion pressure, which is present when blood flow ceases, has not had a practical method described for attainment. An automated tourniquet system was modified to set tourniquet pressure based on measurement of limb occlusion pressure (LOP). In this single surgeon randomized prospective study, the effectiveness of this system was assessed on patients undergoing foot and ankle surgery. Materials and Methods: Two hundred forty-four patients were randomized to the study group of automated pressure ( n = 112) or to the control group ( n = 132). The primary outcome measure was tourniquet pressure used for either group. Secondary measures included the time to set the pressure and number of patients failing LOP measurement. The tourniquet field was assessed intraoperatively and postoperatively in a blinded manner. Results: The tourniquet pressure was significantly lower in the study group at 198. 5 ± 20. 2 mmHg compared to 259. 6 ± 4. 4 in the control group ( p < 0. 001). The time to measure the LOP was 20 ± 6 seconds. Six patients failed to be measured. The quality of the surgical field was judged to be better in the study group based on all three methods of assessment. Conclusion: LOP measurement was a practical way of setting tourniquet pressures for limb surgery. The automated pressure averages were lower than those routinely used by most surgeons for thigh tourniquets. Level of Evidence: I, Prospective Randomized Study

Background: Augment™ Bone Graft, a fully synthetic bone graft material composed of recombinant human PDGF and a calcium phosphate matrix (rhPDGF/TCP), has been considered as a possible alternative to autogenous bone graft. Before proceeding with randomized control studies comparing rhPDGF/TCP to autograft bone, a human trial to assess efficacy and safety was required. Materials and Methods: The current study was a prospective, open-label, multi-center trial designed to evaluate rhPDGF in a calcium phosphate matrix (Augment™ Bone Graft). Sixty patients requiring hindfoot or midfoot fusion were prospectively followed for 36 weeks. All patients received 0.9 to 2.7 mg of rhPDGF at the fusion sites and returned for clinical and radiographic review at Day 7 to 14 and Weeks 6, 9, 12, 16, 24, and 36. Computerized tomography (CT) scans of the fusion site were obtained at the 6- and 12-week postoperative appointment, with an additional CT scan at 16 weeks if required. Results: No patients suffered a serious adverse event caused by rhPDGF. CT scan evaluation at 12- to 16-week time periods revealed moderate or complete osseous bridging of 75% (44/59) at 36 weeks. Conclusion: These results indicate that rhPDGF is a safe product and provides clinical/radiographic outcomes that justify the pursuit of randomized controlled studies comparing rhPDGF/TCP to autograft. Level of Evidence: IV, Case Series

Introduction: This study analysed the factors affecting wound healing of a transmetatarsal amputation (TMA) in patients with diabetes. Materials and Methods: Twenty-one patients who failed a TMA and were revised to transtibial amputation (TTA) within the first year were compared with a matched cohort of 21 successful TMA's. The factors compared included demographics, systemic issues, and local conditions in the foot. Chi-square comparisons were used for group data, and Analysis of Variance (ANOVA) for numeric data. Results: Blood glucose control as measured by HbA1c was the most important single factor predicting the success of TMA. Need for debridement after TMA was also found to be a significant predictor of failure of TMA. There was a trend towards duration of ulcer prior to TMA and smoking being significant. All other variables, including vascular status or renal failure were not significantly different between the two groups. Conclusion: The primary factor determining the success of a TMA was the quality of glucose control. The results of this study can be extrapolated to diabetic patients undergoing other types of surgery, with preoperative diabetic control as measured by HbA1c being an important determinant of the outcome of surgery. As a result of this study we currently do not perform any elective, trauma or emergency surgery on diabetic patients with an HbA1c of over 8 unless the need for surgery is to save life or limb. Level of Evidence: III, Retrospective Comparative Study