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Category: Ankle Arthritis, Hindfoot Introduction/Purpose: Adjacent subtalar (STJ) or talonavicular (TNJ) joint arthritis poses a dilemma in end stage ankle arthritis. The Canadian Orthopaedic Foot & Ankle Society (COFAS) Classification defines such cases as Type 4. In these cases, undergoing total ankle arthroplasty (TAA), fusion of the STJ and/or TNJ or preservation of these joints are both options. Joint preservation may reduce operative time and potential complications but has potential for ongoing hindfoot pain reflected in outcome scores. Hindfoot fusion may offer the potential of greater pain relief, but at the risk of increased OR time and complications. The purpose of this study was to compare the outcomes of patients undergoing TAA with or without STJ and/or TNJ fusion in COFAS type 4 cases. Methods: We retrospectively reviewed prospectively-collected multi-center data on 148 ankles with COFAS Type 4 arthritis that underwent TAA by 7 different surgeons and analyzed the trend of their Ankle Osteoarthritis Scale (AOS) and SF36 Physical Component Summary (PCS) scores pre-operatively and at 1, 2 and 3-5 years post-operatively. Scores were compared between those who underwent fusion of the STJ and/or TNJ (Fusion Group [FG], n=89) and those who did not (Preservation Group [PG], n=59). Multivariant analyses were also performed to account for potential demographic differences within the patient cohorts. The primary outcome measure was the AOS score at latest follow-up (LFU). Secondary outcomes included the SF36 PCS score, COFAS Reoperation Coding System (CRoCS) rates and survivorship. Results: Mean follow up was 6.9 years. Mean pre-operative AOS scores for FG and PG were similar (55.9 and 57.5, respectively, p=0.56). Mean AOS scores at LFU for both groups were insignificantly different (FG – 24.6; PG – 25.2; p=0.89). SF36 PCS scores improved (32.9 pre-operatively to 42.2) at LFU for FG, (33.9 to 40.0) for PG; differences pre-operatively and at LFU were insignificant (p=0.51, p=0.26, respectively). Both groups achieved best mean scores 2 years post-operatively. Multivariant analyses controlling for demographics, comorbidities, surgeon, TAA implant type, and pre-operative score showed no significant difference in mean AOS scores at LFU between both Groups. Reoperations in PG included 2 Code3 procedures (hindfoot fusion) and 2 Code9 procedures (revision of metal components). FG had no Code3 or Code9 procedures. Conclusion: In COFAS Type 4 ankle arthritis cases with adjacent hindfoot arthritis undergoing TAA, our data suggests preservation of hindfoot joints yields similar outcomes to fusion of the hindfoot while potentially avoiding greater operative time, immobilization period, and additional wound/hardware risks associated with concomitant hindfoot fusion. However, preservation carries risk of requiring future reoperation for hindfoot fusion, as seen in 3% of our cases, though this may be countered by the risk of nonunion requiring reoperation when hindfoot fusion is performed primarily. Our results suggest that deferral of hindfoot fusion is a reasonable option in COFAS Type 4 ankles undergoing TAA.

Category: Ankle Arthritis; Ankle Introduction/Purpose: This multi-center study aimed to compare complication rates, reoperation rates, and patient-reported outcome measures (PROMs) between open ankle arthrodesis (OAA) and arthroscopic ankle arthrodesis (AAA) in treating end-stage ankle arthritis. Methods: This was a prospectively collected retrospective study utilizing data from three medical centers in the Canadian Orthopaedic Foot and Ankle Society (COFAS) database. Primary ankle arthrodeses for the treatment of end-stage arthritis with a minimum of 2 years follow up and valid PROM scores were included. Preoperative COFAS ankle arthritis type, validated PROMs including the Ankle Osteoarthritis Scale (AOS), Short Form-36 (SF-36) with 2 components (the Physical Component Summary (PCS) and Mental Component Summary (MCS)), as well as major complications including malunion, nonunion, infection, amputations, and reoperations related to the arthrodesis were evaluated using CROCS (Canadian Reoperation Coding System). Results: 2,835 prospectively enrolled patients who underwent surgical treatment of end-stage ankle arthritis (COFAS Types 1-4) from 2001 to 2020 were screened. 447 ankle arthrodeses were included (178 AAA, 269 OAA) with 1-15 years of followup (7.13 yrs +/- 3.8). There was no difference between the two groups in demographics except more cases of type 1 and 4 arthritis in OAA group. There was a 6.9% incidence of major complications (3.79% related operations around the ankle, 0.67% deep infection, 1.78% revisions for nonunion/malunion, 0.67% amputations). For the 4 types of arthritis, AOS score improved significantly at 1 year, stabilized in type 1 group, but fluctuated in the remaining 3 types of arthritis after 8 years postoperatively. Average postoperative AOS score was better in the AAA group. Conclusion: Better outcomes were found for the arthroscopic cohort. However differences may be less after correction for confounding factors such as surgeon, site, and COFAS grade. Revision surgery is rare in both groups. AOS Treated Total Scores in Arthroscopic versus Open Ankle Arthrodesis Groups

Category: Ankle Arthritis; Other Introduction/Purpose: This study intended to use plantar pressure analysis to obtain supplementary objective outcome assessments of total ankle replacement surgery. Methods: Twenty subjects that were previously consented and booked for total ankle replacements participated in the study. Each subject performed a 10 meter walk prior to surgery and then again at six and twelve months post-operative. Plantar pressures were measured using the Pedar ® (by Novel, Munich, DE) pressure insoles. Six parameters: initial contact time, terminal contact time, maximum force time, peak pressure time, maximum force and peak pressure were calculated and averaged over trials in ten regions of foot. The parameters in each region were compared between pre and post-surgery. Results: We observed that patient’s hind foot total contact time notably increased after total ankle replacement. The average baseline hind foot contact time was 387ms, which increased to 448ms at 6 months post op and further increased to 487ms at the one-year visit. Suggesting that patients are able to better tolerate a load on the hind foot for considerably longer after having ankle replacement surgery. Conclusion: Plantar pressure measurements using the Pedar ® measurement system of pressure and time showed to be strong tools for objective evaluation of ankle joint replacement surgery. Future research comparing outcomes of ankle arthrodesis is planned Pedar software

Category: Ankle Arthritis; Ankle Introduction/Purpose: The Cadence Total Ankle System is unique in that it has modular polyethylene components with both an anterior and posterior biased option that may improve reduction of the talus in the sagittal plane. As such, the purpose of this study is to evaluate the effectiveness of anterior and posterior biased polyethylene liners in improving sagittal component alignment and functional outcomes after TAA. Methods: This was a retrospective cohort study of consecutive patients that underwent TAA with the Cadence Total Ankle system using biased polyethylene liners with at least 12 months follow-up. Results: Study included 66 TAAs that required the use of a biased polyethylene liner. The primary outcome was radiographic sagittal talar alignment, the cohort was broken down into three groups depending on preoperative sagittal alignment: anterior alignment (A, n=38), neutral alignment (N, n=17), and posterior alignment (P, n=11). Patients with anterior or posterior preoperative sagittal alignment demonstrated significant improvement in sagittal alignment using both the TT ratio and talar station. Overall, the proportion of patients that achieved neutral sagittal balance significantly improved from 25.76% to 50.00% postoperatively (χ2 [df=1, n=66] = 18.24, p < 0 .01). Anterior bias liners were associated with anterior preoperative alignment, while posterior bias liners were associated with neutral and posterior preoperative alignment (χ2 [df=2, n=66] = 17.55, p < 0 .01, V = 0.52). Conclusion: The Cadence TAA system has novel anterior and posterior biased polyethylene liners that may augment correction of sagittal talar deformities. This study demonstrates that biased liners are effective in correction of pathological sagittal talar deformities to near anatomic alignment clinical with significant improvement in functional outcomes.

Category: Ankle Arthritis; Ankle Introduction/Purpose: Total ankle replacement (TAR) is increasingly performed on patients across a wide age spectrum, though historically it has been reserved for older patients (>60). In this study, we seek to determine how age influences patient outcomes. Methods: This is a retrospective, comparative cohort study of consecutive patients that underwent TAR from 2004-2021. Patients were categorized into three age groups: < 55, 56-70, and >70. We evaluated surgical complications and patient-reported outcome measures, including Ankle Osteoarthritis Pain & Disability Scores (AOS) and Short Form-36 Health Survey (SF-36). Analysis of covariance was performed, adjusting for patient factors. Results: We reviewed 812 consecutive TARs from a single-centre with 407 (50.1%) male and mean BMI of 29.8±5.78. The median follow up was 64.0 months (IQR,76.0). Patients ≤55 had worse pain preoperatively than both older patient groups (p=0.03) and worse mental health (p< 0.001), however, this difference was not observed in postoperative AOS pain (p=0.15) or SF-36 MCS scores (p=0.87). Patients >70 had worse physical health than patients 56-70 (p=0.02) and less change in pre- to postoperative SF-36 PCS scores (p=0.02). Patients from all groups improved similarly according to the AOS pain (p=0.15) and disability (p=0.12). Conclusion: These results show that TAR patients younger than 55 have worse pain and mental health preoperatively but have similar long-term clinical outcomes to patients 56 and older.

Background: End-stage ankle osteoarthritis is a condition that can be treated with ankle arthrodesis (AA) or total ankle arthroplasty (TAA). The goal of this study is to estimate the 2016-2017 United States’ utilization of TAA and AA in specific ambulatory settings and delineate patient and hospital factors associated with the selection of TAA vs AA for treatment of ankle osteoarthritis. Methods: TAA and AA procedures performed for ankle osteoarthritis were identified in the 2016-2017 Nationwide Ambulatory Surgery Sample (NASS) Database. Notably, the NASS database only examines instances of ambulatory surgery encounters at hospital-owned facilities. As such, instances of TAA and AA performed at privately owned or freestanding ambulatory surgical centers or those performed inpatient are excluded from this analysis. Cases were weighted using nationally representative discharge weights. Univariate analyses and a combined multiple logistic regression model were used to compare demographic, hospital-related, and socioeconomic factors associated with TAA vs AA. Results: In total, 6577 cases were identified, which represents 9072 cases after weighting. Of these, TAA was performed for 2233 (24.6%). Based on the logistic regression model, several factors were associated with increased utilization of TAA vs AA. With regard to patient factors, older patients were more likely to undergo TAA, as well as females. Conversely, patients with a higher comorbidity burden were less likely to receive TAA over AA. With regard to socioeconomic factors, urban teaching and urban nonteaching hospitals were significantly more likely to use TAA compared to rural hospitals. Similarly, privately insured patients and those with a median household income of $71 000 or more were also more likely to receive TAA over AA. Private hospitals (“not-for-profit” and “investor-owned”) were significantly more likely to offer TAA over AA. Conclusion: Using a large nationally representative cohort, the current data revealed that during 2016-2017, 24.6% of operatively treated cases of end-stage ankle osteoarthritis in the ambulatory setting are treated with TAA. Associations between socioeconomic and hospital-level factors with TAA utilization suggest that nonclinical factors may influence surgical treatment choice for ankle osteoarthritis. Level of Evidence: Level III, retrospective cohort study.

Category: Hindfoot; Ankle Introduction/Purpose: Recombinant human platelet-derived growth factor (rhPDGF) is commonly used in hindfoot and ankle arthrodesis as an alternative to autologous bone graft, the current gold standard grafting material. The largest randomized controlled trial ever conducted in foot and ankle arthrodesis showed that rhPDGF was associated with similar successful radiographic and clinical outcomes to those of autologous bone graft at 24 months. The objective of this study was to determine if outcomes remained similar for these two grafting materials at long-term follow-up. Methods: All 37 sites (414 subjects) from the previously conducted randomized controlled trial examining outcomes for hindfoot and ankle arthrodesis supplemented with either rhPDGF or autologous bone graft (randomized 2:1) were invited to return for a single visit occurring at a minimum follow-up of 60 months. All returning subjects who provided consent were evaluated with computed tomography (CT) scans, American Orthopaedic Foot & Ankle Society (AOFAS) Scores, Foot Pain and Disability (FFI) Scores, and visual analog scores (VAS) assessing fusion site, weight bearing, and graft harvest site pain. Because final fusion status was dependent upon the status exiting the original trial, maintenance or improvement of fusion status was the key focus of the study. The change in baseline from all other outcomes measures were also compared between the two groups. Results: A total of 169 subjects (109 rhPDGF, 60 autologous) from 26 sites completed a follow-up visit at a mean 9.1 years (7.7- 10.9).The rate of maintenance or improvement of CT fusion status was statistically noninferior for subjects in the rhPDGF group compared to the autologous bone graft group (92.7% vs. 95.0%,p=0.021), Total AOFAS Scores (74.9+16.7 vs. 77.2+13.9, p20) at their graft harvest site. Conclusion: The outcomes of rhPDGF in hindfoot or ankle arthrodesis were statistically noninferior to those of autologous bone graft at a mean follow-up of 9.1 years. Over 92% of rhPDGF subjects maintained or improved their fusion status. Similarly, the baseline change for all VAS and functional outcomes were non-inferior for the two groups. The exception was clinically significant graft harvest site pain, which only existed in the autologous bone graft group. The results of this study demonstrate that rhPDGF used in hindfoot and ankle arthrodesis is associated with similar long-term radiographic, functional, and clinical outcomes as autologous bone.

Category: Midfoot/Forefoot Introduction/Purpose: 'MoAkin' biplanar proximal phalanx closing wedge osteotomy with dorsal cheilectomy has been described as an effective procedure for treatment of hallux rigidus with hallux valgus interphalangeus (HVI). Its role as an adjunct procedure to first metatarsophalangeal joint hemiarthroplasty using a synthetic cartilage implant has not been well described. The purpose of this radiographic analysis was to examine radiographic changes associated with the MoAkin osteotomy performed in patients who underwent first MTPJ hemiarthroplasty using the Cartiva implant. Methods: A retrospective study of all patients with hallux rigidus and HVI treated with a synthetic cartilage implant and MoAkin osteotomy between 2009 and 2020 was conducted. Radiographs were performed preoperatively and at six- and/or twelve-month postoperatively, and evaluated using standardized measurement techniques. Hallux valgus angle (HVA), interphalangeal angle (IPA), and intermetatarsal angle (IMA) were measured. Results: Fifty-four patients were included in the study (37 male; 17 female). Mean preoperative HVA, IPA, and IMA were 11.7+- 4.2 degrees, 15.8+-4.6 degrees, and 8.2+-2.4 degrees, respectively. Mean six-month postoperative HVA, IMA, IPA were 7.7+-4.2 degrees, 15.7+-5.7 degrees, and 8.2 +- 3.0 degrees. Mean twelve-month postoperative HVA, IMA, IPA were 8.0+-4.5 degrees, 15.2+-6.1 degrees, and 8.1+-2.9 degrees. No statistical differences were found between the six-month and twelve-month radiographic analysis (p>=0.59). There was a statistically significant reduction in the hallux valgus angle at six and twelve-month follow up compared to the preoperative angles (p=0.31). Conclusion: MoAkin osteotomy improves the hallux valgus angle in patients with hallux rigidus and HVI undergoing first MTPJ hemiarthroplasty with the Cartiva implant. Further studies are warranted to evaluate the impact of these radiographic findings on patient-reported outcomes and other clinical outcomes.

Category: Ankle; Ankle Arthritis Introduction/Purpose: There is limited literature on the effects of socioeconomic factors on outcomes after total ankle arthroplasty (TAA). In the setting of hip or knee arthroplasty, patients of a lower socioeconomic status demonstrate poorer post- operative satisfaction, longer lengths of stay, and larger functional limitations. It is important to ascertain whether this phenomenon is present in ankle arthritis patients. This is the first study to address the weight of potential socioeconomic factors in affecting various socioeconomic classes, in terms of how they benefit from ankle arthroplasty. Methods: This is retrospective cohort study of 447 patients who underwent a TAA. Primary outcomes included pre-operative and final follow-up AAOS pain, AAOS disability, and SF-36 scores. We then used postal codes to determine median household income using Canadian 2015 census data. Incomes were divided into quintiles based on equal amounts over the range of incomes. These income groups were then compared for differences in outcome measures. Statistical analysis was done using unpaired t- test. Results: A total of 447 patients were divided into quintiles by income. From lowest income to highest income, the groups had 54, 207, 86, 64, and 36 patients, respectively. The average time from surgery to final follow up was 85.6 months. Interestingly, we found that patients within the middle household income groups had significantly lower AAOS disability scores compared to the lowest income groups at final follow-up (26.41 vs 35.70, p=0.035). Furthermore, there was a trend towards middle income households and lower post-operative AAOS pain scores compared to the lowest income group (19.57 vs 26.65, p=0.063). There was also a trend toward poorer AAOS disability scores when comparing middle income groups to high income groups post- operatively (26.41 vs 32.27, p=0.058). Pre-operatively, patients within the middle-income group had more pain, compared to the lowest and the highest income groups. Conclusion: Patients from middle income groups who have undergone TAA demonstrate poorer function and possibly more pain, compared to lower and higher income groups. This suggests that TAA is a viable option for lower socioeconomic groups and should not be a source of discouragement for surgeons. In this circumstance there is no real disparity between the rich and the poor. Further investigation is needed to explore reasons for diminished performance in middle class patients.

Category: Basic Sciences/Biologics; Other Introduction/Purpose: Metal hypersensitivity is common in the general population, affecting between 10-15%. Many different metals are constituents of orthopaedic devices used for foot and ankle surgery; therefore, it is expected to influence patient outcomes. A variety of different reactions, both systemic and localized, have been reported, along with treatment strategies. However, there is no accepted protocol to evaluate, diagnose and manage patients with suspected metal hypersensitivity reactions. Current literature characterizing metal hypersensitivity in foot and ankle and guidance on management is lacking. Methods: A comprehensive literature search of Ovid MEDLINE and EMBASE was performed from inception to 23-Nov-2021 using MeSH search terms focusing on the foot and ankle, orthopaedic surgeries, a variety of metal types, and hypersensitivity reactions. A total of 43 studies were identified. All full-text, English, experimental and observational studies, reporting on metal hypersensitivity in the context of foot and/or ankle surgeries using metal-containing orthopaedic devices were included. Article screening, quality assessment, and data extraction was performed by two reviewers. Disagreements were resolved by discussion or the vote of a third reviewer. Results: A total of 45 patients (18 male and 27 female) were included from 15 papers. Mean age was 55.5 years. There were 42 static and three arthroplasty implants included. Metal hypersensitivity diagnosis was performed with specialist consults, and most commonly, patch testing (e.g. with standard array or implant components). Patch testing was most commonly positive to nickel (thirteen), followed by cobalt (four), vanadium (three), and other less commonly used metals. Mean follow up was 20.8 months. Fifteen patients (12 with a positive patch test, 1 with a negative patch test and two not tested), all symptomatically improved following metallic implant removal; four patients had implants removed for unclear reasons; one patient remained symptomatic despite implant removal but had a negative patch test. The remaining 25 patients retained their implants without significant symptoms regardless of patch test result. Conclusion: Metal hypersensitivity in the context of foot and ankle surgery is not widely reported. It should be considered as a differential diagnosis in patients who present with hypersensitivity-type symptoms with previous surgery with metallic implants, after infection and mechanical failure have been ruled out. Patch testing can be helpful in identifying these patients. Removal of static implants after fracture union in trauma cases typically resulted in symptom resolution. Metallic arthroplasty implant removal presents more of a clinical challenge. Future research should focus on creating a framework to identify at risk patients and diagnose foot and ankle patients with metal allergy.

Category: Midfoot/Forefoot Introduction/Purpose: There are several treatments for hallux rigidus, including the use of a synthetic cartilage implant (SCI). Level I studies have shown success with these implants, but some patients do require conversion to arthrodesis for ongoing symptoms. The purpose of this radiographic review was to examine if baseline bone alignment, dimensions, and arthritis status are were different for patients who required conversion to arthrodesis compared to a control group with successful outcome. Methods: A radiographic review was conducted using data for from 15 hallux rigidus subjects implanted with an SCI enrolled in a during a previously concluded Level 1 clinical trial. Ten (10) Success subjects were identified as subjects those without conversion and with the lowest VAS pain levels indicating the most favorable outcome formed a success (control) group. Five (5) Conversion (study) subjects were identified as those with a conversion requiring revision to fusion and the with highest VAS scores indicating the least favorable outcome. Preoperative Weight-bearing AP and lateral radiographs from baseline visits were reviewed. Using previously validated Quantitative Motion Analysis software, two radiologists made the following measurements: first interphalangeal angle; first/second intermetatarsal angle; hallux valgus intraphalangeal angle; metatarsus adductus angle; metatarsal declination angle; first to second metatarsal length; functional ratio; and first metatarsal cortical thickness. Preoperative assessments of arthritis grade, metatarsalus primus elevatuselevation, sesamoid arthritis, and sesamoid station were also performed. Results: First metatarsal length was approximately 3% larger longer in the Conversion group compared to the Success group (85.2% vs. 82.5%). This was driven by the Conversion group having longer median normalized first metatarsal length (88.5% vs. 86.6%) and shorter median normalized second metatarsal lengths (104.0% vs. 106.3%). First metatarsal The second exception was cortical thickness was greater in the conversion group. This measurement was defined as the combined width of the medial and lateral cortices measured at the midline of the first metatarsal normalized to the full midline diameter of the first metatarsal. The median cortical thickness was almost 7% larger in the Conversion group compared to the Success group (40.1% vs. 33.2%). Nine Success subjects and 2 Conversion subjects had Grade 3 arthritis, while all other subjects had Grade 2. Three (60%) Conversion subjects and two (20%) Success subjects had evidence of metatarsus primus elevatus. Conclusion: Baseline joint alignment did not correlate with the need for conversion to arthrodesis. Conversion subjects had larger functional ratios longer first rays and greater cortical thickness. Published literature suggests smaller functional ratios result in increased second ray loading. It is possible the opposite is occurring in Conversion subjects, with longer first and shorter second metatarsal lengths resulting in increased loading of the SCI implant. The result indicates that shortening the first ray may be required to achieve a successful outcome with SCI. Success patients had a lower incidence of metatarsus primus elevatus.

Background: Total ankle arthroplasty (TAA) is a surgical procedure commonly reserved for patients suffering from symptomatic end-stage ankle arthritis. As the number of TAAs increases, so does the associated economic burden. Given these economic constraints, there has been interest in the feasibility of outpatient TAA. The purpose of this study is to evaluate the safety, efficacy, and satisfaction of patients undergoing outpatient TAA. Methods: This is a retrospective case series of consecutive patients who underwent outpatient TAA from July 2018 to June 2019. Inclusion criteria included any patient undergoing a primary TAA in the outpatient setting. This was defined as discharge on the same day of surgery or within 12 hours of surgery. All surgeries were completed by a single experienced surgeon through an anterior approach using the Cadence Total Ankle System. Prior to surgery, all patients received a popliteal nerve block. Patients were then discharged home with oral analgesic and a popliteal nerve catheter, which they removed after 48 hours. The primary outcome of interest was postoperative pain control, which was measured using a numeric scale. Secondary outcomes included complication rate, readmission rate, and patient satisfaction. A review of the current literature was then completed to supplement our results. Results: In total, 41 patients were included in our analysis. In terms of the primary outcome, the average numeric scale score was 1.98, indicating excellent pain control. Additionally, nearly all 41 patients stated they were very satisfied with their postoperative pain control regimen. In terms of secondary outcomes, the majority of patients stated they were satisfied with discharge on the same day as surgery. There were no readmissions or major complications in our outpatient TAA cohort. When asked if they would recommend the care they experienced to a friend with the same condition, 95% of patients said that they would recommend this care pathway. Our literature review included 5 original studies, which were all retrospective level IV studies. These studies uniformly demonstrated the safety and efficacy of outpatient TAA. Conclusions: The results of our study demonstrate the outpatient TAA is associated with excellent pain control using a multidisciplinary pain approach. The use of standardized outpatient postoperative pathways was effective in preventing readmissions and complications, while still resulting in high patient satisfaction scores. A review of the literature complemented our results, as there are largely no significant differences between outpatient and inpatient TAA. Level of Evidence: Level IV, case series.

Category: Ankle; Ankle Arthritis; Basic Sciences/Biologics; Hindfoot Introduction/Purpose: A recent survey of 100 international foot and ankle orthopaedic surgeons revealed that patient age greater than 60 years is not considered to be a significant risk factor for nonunion following foot and ankle arthrodesis. This finding was surprising as published basic science research shows that autologous bone graft used during fusion surgery may be less effective when harvested from older patients due to both diminished osteogenic potential and migration capacity of mesenchymal stem cells. The purpose of this study was to evaluate the impact of patient age and graft type on fusion rates following hindfoot and ankle arthrodesis. Methods: A Level 1 clinical trial was performed comparing fusion success in 397 hindfoot or ankle arthrodesis subjects (597 joints) supplemented with either autograft or an osteoinductive recombinant human protein derived growth factor (rhPDGF- BB/β-TCP) bone graft substitute. Fusion status was determined using computed tomography, with fusion defined as evidence of at least 50% osseous bridging. In this secondary analysis of that dataset, the odds of fusion success were compared for joints in autograft subjects older or younger than the following age thresholds: 55, 60, 65, 70 and 75 years. This analysis was then repeated for joints in rhPDGF-BB/β-TCP subjects. Finally, odds of fusion success were also compared for the autograft and rhPDGF-BB/β- TCP groups for subjects older than each threshold age. Results: Joints in autograft subjects younger than 60 and 65 years exhibited over two times the odds of fusion as those in older subjects (60 years: OR 2.24, p=0.003; 65 years: OR 2.74, p

Category: Midfoot/Forefoot; Other Introduction/Purpose: Synthetic cartilage implants for first metatarsophalangeal osteoarthritis have been used for nearly a decade with Level 1 clinical evidence showing 84.9% of implants remain in place at a mean follow-up of 5.8 years. In contradiction to these positive results, however, some recent publications have shown higher revision rates and attempted to correlate the need for revision with the postoperative joint space interval. Most of these studies performed assessments based off of routine anterior-posterior (AP) radiographs using hand drawn measurements without image calibration or scaling. The purpose of this independent radiographic review was to further explore any relationship between joint space integrity and the need for revision surgery. Methods: An independent radiographic review by two board-certified, fellowship-trained, practicing musculoskeletal radiologists with no competing financial interests was conducted for 15 subjects from a previously concluded Level 1 clinical trial looking at outcomes of a synthetic cartilage implant. Ten (10) subjects with positive outcomes and 5 who required revision were selected at random for evaluation. Weight-bearing AP and lateral radiographs at baseline, 2 weeks, 6, 12, 24, and 60 months were reviewed. Using previously validated Quantitative Motion Analysis software, joint space was measured in the medial, central, and lateral locations on AP radiographs and dorsal, central, and plantar locations on lateral radiographs (Coughlin et al. 2003). Measurements were normalized to the proximal phalanx width in the relevant view (AP or lateral) to adjust for lack of image scaling or calibration. Normalized joint spaces at each interval and changes from the 2-week visit, the earliest with the implant in place, were evaluated. Results: In this pilot study, no relationship between mean normalized joint space and implant removal was found at any time point over the 60-month follow-up. Scatterplots were used to determine if movement in different directions impacted mean values. There was significant overlap for the two groups in joint space at each subject’s final visit with the implant in place and the change from the 2-week visit to the final visit (Figure 1). The majority of subjects in both groups experienced changes in joint space of less than 10% across all measurements. The maximum change from the 2-week visit in the revision group was less than 15%, compared to over 25% for subjects in the retention group. Conclusion: Neither joint space at final follow-up nor joint space change from initial postoperative assessment were associated with revision. The maximum observed decrease in the revision group was less than 15%, or 0.5 mm in a joint space of 3 mm. Both the clinical relevance of this minimal decrease and whether or not it can be reliably assessed remain unclear. Future studies could examine patient factors other than joint space to determine success or failure of this implant. These preliminary results suggest joint space integrity evaluated from plain film is a weak indicator of clinical efficacy with this synthetic cartilage implant.

Category: Ankle Introduction/Purpose: Wound complications can lead to devastating outcomes in major ankle procedures such as total ankle arthroplasty. Up to 28% wound healing complications have been reported with anterior approach to the ankle. Anteromedial approach is an angiosome based approach for ideal wound healing especially in those with high risk factors. Methods: The procedure includes the following steps: 1. Make the Incision along the medial border of the anterior angiosome fed by anterior tibial artery and dorsalis pedis 2. Create full thickness lateral flap by dissecting through the extensor retinaculum, along the course of the tibialis anterior tendon 3. Stay sutures are placed full thickness through the retinaculum and EHL, the full thickness flap is then retracted laterally with the anterior neurovascular bundle 4. The interval between the tibialis anterior tendon and lateral flap is used to perform the total ankle replacement 5. Adequate and full exposure of the distal tibia and ankle joint is achieved. Retrospective chart review of patients who underwent anteromedial approach for elective ankle procedures from Jan 2012 to 2018 was performed. Patient demographics (age, BMI), medical comorbidities, smoking status, pertinent trauma history, follow up duration, and wound complications were collected. Results: Total 73 patients underwent extensile anteromedial approach. Mean age was 48, mean follow up was 24 (range 12 to 73) months. There were no instances of skin flap necrosis. One patient with chronic venous insufficiency developed a small superficial wound infection that healed with dressing changes alone. Conclusion: Anteromedial approach to ankle is a reasonable alternative to standard anterior approach to achieve optimal wound healing in ankle procedures in a high-risk patient for wound healing. The approach allows complete access to the ankle joint keeping the angiosomes intact which helps in excellent wound healing. Figure 1.

Category: Ankle Arthritis Introduction/Purpose: Outpatient total joint arthroplasty (OTJA) allows for a safe, cost effective pathway for appropriately selected patients. Total ankle arthroplasty (TAA) is a surgical procedure commonly used for patients with painful arthritis. As the number of TAA procedures increase, so does the associated economic burden. The purpose of this study was to evaluate patients undergoing total ankle arthroplasty, who were discharged on the same day as undergoing surgery. These patients have stayed in the hospital for

Category: Ankle; Ankle Arthritis Introduction/Purpose: The success of total ankle arthroplasty (TAA) depends on many factors, including patient selection, prosthetic design, soft tissue balancing, severity of joint deformity, and component position. Malposition of the components increases contact pressures and diminishes prosthesis survival / patient outcomes; therefore, anatomic alignment of the prosthesis is desirable. Sagittal malalignment of the talar component is common and has been associated with lower outcome scores. Cadance Total ankle system is unique in that it has modular polyethene components with both an anterior and posterior biased option that may help improve reduction of the talus in the sagittal plane. The purpose of this study is to evaluate the effectiveness of anterior and posterior biased polyethylethene liners in improving sagittal component alignment in patients with preoperative sagittal translational deformities Methods: This is a prospective radiographic and clinical study of patients that underwent TAA with the Cadence TM system using biased polyethylene liners with at least 12-months follow-up. All surgeries were performed by a single surgeon with extensive experience in TAA between July 2016 and December 2018. Patients underwent TAA in a standard fashion using an anterior approach, and then underwent clinical evaluation at standardized time points with administration of the Ankle Osteoarthritis Scale (AOS) and the Short Form Health Survey (SF-26). Radiographic outcomes included assessment of sagittal plane component alignment using the tibiotalar (TT) ratio and tibial-axis-to-lateral-process distance at preoperative and at postoperative visits. Results: The cohort included a total of 7O TAA which demonstrated pre-operative sagittal talar malalignment and/or intra- operative sagittal instability where a biased polyethylene liner was inserted. Preoperative talar sagittal translation was 54 anterior, 6 posterior and 10 were neutral. 30 anterior biased polyethylene and 40 posterior biased polyethylene were used. Sagittal translation decreased from an average 4.2 mm to 0.8 mm. The T-T ratio averaged 40.8 +- 10.8 % on preoperative x-ray and 38.1 +- 3.6 % on postoperative. The pre and post-operative pain and disability scores displayed statistically significant improvements wherein AOS pain scores decreased 25.28 +- 14.34 points from an average of 45.86 points while AOS disability scores decreased -30.11 +- 22.70 from an average of 56.15 points. Conclusion: Sagittal translational deformities associated with end-stage ankle arthritis are common and should be corrected during TAA to improve loading kinematics and implant longevity. The Cadence TAA has anterior and posterior biased polyethylene liners that help to correct sagittal talar translational deformities. This study demonstrates that biased liners are effective in improved postoperative clinical outcomes with significant correction of pathological sagittal translation to near anatomic alignment.

Category: Ankle; Hindfoot; Other Introduction/Purpose: Autologous bone has traditionally been the gold standard for grafting material during foot or ankle arthrodesis. While autograft use has been effective, its harvest does present certain distinctive risks to the patient including persistent harvest site pain. Previous studies have examined harvest site pain, but most have focused on the iliac crest and none provide longer term follow-up. The purpose of this study was to examine long-term (7-10 year) donor site pain from four lower extremity harvest site locations in subjects undergoing autograft harvest for hindfoot or ankle arthrodesis. Methods: All subjects in the control arm of a previously conducted Level 1 clinical trial comparing autologous bone with a synthetic bone graft substitute for hindfoot or ankle arthrodesis were invited back for a single visit at a minimum of 5 years following their initial surgery. Autograft was harvested from either the proximal tibia (51.7%), iliac crest (17.2%), calcaneus (15.5%), distal tibia (6.8%), or other location (8.6%). Harvest site pain, fusion site pain, and weight-bearing pain were evaluated using a 100-point visual analog scale (VAS), with clinically significant pain considered as any score greater than 20 (Todd et al., 1996). Results: Of the 130 subjects receiving autograft in the original trial, 58 returned for assessment at a mean follow-up of 9.0 years (Table 1). The mean harvest site VAS at final follow-up was 4.4 (range, 0.0-97.0) with 37.9% of subjects reporting some level of pain. The percentage of subjects who reported clinically significant pain was 35.7%, 21.4%, 18.2%, 10.5%, 8.9%, and 5.2% at 2, 6, 12, 24, 52 weeks, and final follow-up, respectively. Of those subjects reporting clinically significant pain at final follow-up, two had undergone harvest from the proximal tibial and one from the iliac crest. A significant correlation was found between harvest site pain and both weight-bearing and fusion site pain, but not between harvest site pain and the volume of graft harvested. Conclusion: This study is the first to examine persistence of long-term harvest site pain following autologous bone graft harvest during hindfoot or ankle arthrodesis. Over one-third of patients still reported persistent pain at an average follow-up of 9 years, with 5% experiencing clinically significant pain. The proximal tibia harvest site had the greatest incidence of reported pain. These data suggest that harvesting autologous bone does carry inherent risk of persistent, long-term pain. This factor should be considered when informing patients of procedural risks and when choosing between autograft or graft substitute during arthrodesis surgery.

Category: Ankle Arthritis Introduction/Purpose: Despite advancements with instrumentation and implant design, total ankle arthroplasty (TAA) is still associated with a high rate of wound complications, which can lead to poorer outcomes. The aim of this study was to evaluate all wound complications following TAA and to determine any demographic or operative associations. Methods: A retrospective review of 660 consecutive TAAs was performed between November 2001 and May 2017. Data was collected on wound complications and potential risk variables, including age, sex, body-mass index, diabetes, smoking, and inflammatory arthritis. All wounds were seen at the clinic by the surgical team and a wound specialist nurse who independently recorded any issues. Major wound complications were those that required consultation with plastic surgeons, debridement by the nurse specialist, use of negative pressure therapy, or return to the operating room. All major complications were treated initially with oral antibiotics. Minor wound complications included any mention of discoloration, swelling, or clinical concern that merited the patient returning for further review. Minor wound complications were not treated with oral antibiotics. Operative notes were also reviewed to collect data on the surgical approach and additional incisions. Results: Fifty-nine patients (8.9%) had wound healing issues: 19 major (2.9%) and 40 minor (6.1%). All issues became evident

Category: Ankle, Ankle Arthritis Introduction/Purpose: A wide range of patient-reported outcome measures are used to evaluate ankle reconstruction outcomes, but there is little agreement regarding which best captures patients’ perceptions of illness and treatment outcomes. There has been little exploration of what outcomes are important to patients. Qualitative work offers one approach to try to understand patients’ experiences of ankle reconstruction for treatment of end-stage ankle osteoarthritis. Methods: Individuals were recruited from an existing cohort of persons who had undergone total ankle replacement or ankle fusion. Twenty-five English-speaking individuals who had surgery at least one year prior and were receptive to in-depth interviews were asked to participate following a routine clinic visit. Semi-structured, face-to-face interviews were conducted by a qualitative researcher in a private hospital room. Results: Twenty-five adults (12 women, 13 men) ages 25–82 years were interviewed for 1–2 hours. Participants commonly described a state of having to keep careful watch for potential environmental challenges on a daily basis. ‘Vigilance’ was related to ongoing symptoms (i.e. pain, stiffness) and concerns related to balance, stability, and damage to the fused ankle or implant. Findings indicated that vigilance existed along a continuum with higher levels associated with stress, mental exhaustion, and a negative impact on relationships with friends and family. Vigilance appeared to effect participants’ perception of their surgical outcome, with high levels of vigilance linked to negative perceptions of outcome. The degree to which individuals perceived they needed to be vigilant was influenced by environmental factors like uneven ground or crowds. Conclusion: Vigilance, or the constant appraisal of the environment and personal ability, is not captured by current instruments assessing ankle reconstruction outcomes. However, the mental load and worry associated with high ‘vigilance’ was important to patients and played a role in their perception of outcome, distinct from related pain or functional status. As such, reducing high levels of vigilance appears to be an appropriate target for patient-centered treatment outcomes and one that can be managed or remedied. A thorough outcome battery for ankle reconstruction should consider this domain.

Category: Ankle, Ankle Arthritis Introduction/Purpose: Over the last few decades, total ankle replacement (TAR) emerged as a reliable treatment option in end-stage ankle osteoarthritis (OA) while preserving motion and physiological load. The Cadence™ prosthesis, manufactured by Integra LifeSciences, is a two-component, fixed-bearing implant with minimal tibial and talar resection and has been in clinical use since June 2016. The purpose of this study is to assess the two-year validated clinical outcome scores and radiological parameters of the Cadence™ prosthesis at our hospital. Methods: Thirty-one consecutive patients who received the Cadence™ prosthesis between June 2016 and December 31st, 2016 were enrolled. All patients who underwent a primary TAR with the Cadence™ prosthesis and who had at least two years follow- up were included. All surgeries were performed by a single surgeon with experience in total ankle arthroplasty. At the yearly clinical evaluation, patients were administered the Ankle Osteoarthritis Scale (AOS) and the Short Form Health Survey (SF-36), and their radiological outcomes pre and post-surgery were assessed. Results: Thirty-one patients fulfilled the inclusion criteria. Forty ancillary procedures were performed on twenty-four TAR’s. Radiological analyses showed preoperative talar sagittal translation with 25 anterior, 2 posterior, and 4 neutral. Sagittal translation decreased from an average 3.11 mm to 1.0 mm. Eleven ankles had a perioperative talar Varus and Valgus deformity that was corrected, with neutral alignment in all. At the two-year clinic visit, x-rays showed no lucencies or stress fractures and none of the ankles required revision of metal components. The pre and post-operative pain and disability scores displayed major improvement wherein AOS pain scores decreased -20.28 ± 14.34 points from an average of 47.86 points while AOS disability scores decreased -32.11 ± 22.70 from an average of 57.15 points. Conclusion: The overall outcome of the total ankle arthroplasty with the Cadence™ prosthesis showed excellent clinical and radiological outcomes. Compelling clinical evidence shows that the quality of life, functional measures, and pain in patients suffering from end-stage arthritis significantly improved following surgery with the Cadence™ total ankle replacement system. The semi- constrained design of this two-component implant and utilization of biased polyethylene inserts allowed for correction of the talus in both the sagittal (talar anterior / posterior translation) and coronal planes (talar varus / valgus).

Category: Ankle Arthritis Introduction/Purpose: Total ankle replacement (TAR) and ankle arthrodesis are both effective treatments for end-stage ankle arthritis, however differences in treatment outcomes may be better understood using a qualitative inquiry among individuals who have undergone both procedures. The purpose of this study was to investigate patients’ experiences and impressions of living with bilateral TAR and ankle arthrodesis. Methods: The sample consisted of 10 patients, selected purposively from a larger cohort, who could speak English and had a TAR on one side and ankle arthrodesis on the contralateral side. All procedures were completed by a single experienced surgeon. Semi-structured interviews were conducted at least one year after completion of the most recent procedure (TAR or arthrodesis). Qualitative data analysis was performed in accordance with a descriptive phenomenological theoretical approach, from which codes and themes were derived. Results: Interviews revealed advantages and disadvantages associated with both TAR and ankle arthrodesis from the patients’ perspective. Two overarching domains in which differences between their TARs and ankle fusions emerged: psychological and musculoskeletal. Within these domains, concepts of vigilance (as previously described by Pinsker) and strategizing the use of one ankle over the other emerged as themes that unified nearly all patients. Specific differences between the two procedures with respect to stability versus flexibility were commonly identified. Overall, patients preferred their TAR. Conclusion: This study provides insight into the lived experiences of a unique group of patients who have both an ankle arthrodesis and TAR. Patients evaluated the impact of TAR and ankle arthrodesis on their lives and overwhelmingly favoured TAR. The findings of this study can help clinicians to better counsel patients on expectations after TAR and ankle arthrodesis, and may aid researchers improve patient-report measurement instruments to better capture the outcomes that are important to patients.

Category: Ankle, Ankle Arthritis, Outcomes research Introduction/Purpose: Patients’ perception of a good outcome (‘feeling recovered’) is not fully understood. A clear understanding of the benefits and harm of a surgery is necessary for clinical decision-making. Qualitative work exploring the nature of patient recovery would improve our ability to understand and measure these outcomes. The purpose of the study is to examine patients’ perceptions of post-surgical outcome following ankle reconstruction for treatment of end-stage ankle arthritis. Methods: Twenty-five English-speaking individuals were asked to participate following a routine clinic visit. They were recruited from an existing cohort of persons who had undergone total ankle replacement or ankle fusion at least one year prior. A qualitative researcher conducted semi-structured, face-to-face interviews with participants in a private hospital room. Results: Twenty-five adults (12 women, 13 men) ages 25–82 years were interviewed for 1-2 hours. Participants varied in their socioeconomic status and education levels. Patients did not view their recovery simply as physiological change. Most participants reported ongoing challenges or difficulties, yet considered themselves better. Participants described a broader concept of recovery with multiple contributing factors, including appraisal of the importance of ongoing issues and coping efforts. When participants experienced ongoing difficulty with valued activities, they gained a sense of recovery using coping efforts. Many ‘readjusted’ behaviorally to continue with their valued goals and activity preferences. Others cognitively redefined their goals or preferences to accommodate their ongoing issues. Participants who could not cope with their difficulties or disliked their coping effort perceived their recovery negatively. Conclusion: Perception of recovery and experience of outcome rarely involved resolution of all symptoms and functional limitations. The manner in which patients described their recovery was typically more nuanced than a simple change in magnitude of symptoms or functional limitations. This research expands our understanding of the experience of ankle reconstruction and draws attention to different meanings of recovery that has implications for outcome evaluation and measurement. Improved measures for evaluating the recovery outcome states will enable clinicians to identify facilitators and barriers to recovery.

Category: Midfoot/Forefoot Introduction/Purpose: Hallux rigidus is the most common arthritic condition of the foot. A prospective, randomized, non-inferiority clinical trial of first metatarsophalangeal joint (MTPJ) hemiarthroplasty with a synthetic polyvinyl alcohol hydrogel implant, for moderate to severe hallux rigidus, demonstrated maintenance of MTPJ active dorsiflexion motion and excellent pain relief; additionally, the trial showed functional outcomes and safety equivalent to first MTPJ arthrodesis at 24 months (Baumhauer et al. 2016; FAI:37(5):457-469). Recognizing that many hemiarthroplasty and total toe implants have initially good results that deteriorate over time, the purpose of this study was to prospectively assess the safety and efficacy outcomes for the synthetic cartilage implant population and to determine if the excellent outcomes were maintained at >5 years. Methods: One hundred and fifty-two patients underwent implant hemiarthroplasty in the original trial; 14 underwent implant removal and conversion to fusion and 3 were lost to follow-up during the first 24 months, leaving 135 eligible for this study. One hundred patients were evaluated at 5+ years; 5 could not be reached for follow-up. Thirty are pending consent, follow-up, and/or data entry; their status will be available for inclusion at the conference presentation. Patients completed a pain visual analogue scale (VAS) and Foot and Ankle Ability Measure (FAAM) Sports and Activities of Daily Living (ADL) scores, preoperatively and at 2, 6, 12, 26, 52, 104 and 260 weeks postoperatively. Minimal clinically important differences are: =30% difference for pain VAS, 9 points for FAAM Sports, and 8 points for FAAM ADL. Great toe active dorsiflexion, weight-bearing radiographs, secondary procedures, and safety parameters were evaluated. Results: Of 100 synthetic cartilage implant hemiarthroplasty patients available at mean 5.8 years follow-up (SD ±0.7; range: 4.4- 7.4), 5 underwent implant removal and conversion to fusion in years 2-5 (Figure 1), and 2 underwent subsequent surgical interventions during the pivotal trial and were censored, leaving 93 patients for evaluation. Pain and function outcomes observed at 5.8 years were similar to those at 2 years (Figure 1). VAS Pain and FAAM Sports Scores were maintained or improved at 5.8 years follow-up, but these differences were not clinically significant. Joint motion was maintained at 5.8 years. No evidence of avascular necrosis, device migration or fragmentation was observed upon independent radiographic review. Eighty-six percent of patients agreed their overall well-being had improved, and 92% would have the procedure again. Conclusion: Clinical and safety outcomes of patients having undergone synthetic cartilage implant hemiarthroplasty for the surgical treatment of hallux rigidus were previously demonstrated to be non-inferior to the gold standard treatment, MTPJ fusion, at 2 years. Prospectively determined outcomes for 100/135 of these implant hemiarthroplasty patients at 5.8 years are similar to those reported at 2 years. Longer-term results demonstrate that clinical and safety outcomes for synthetic cartilage implant hemiarthroplasty are durable, and that the implant remains a viable treatment option to decrease pain, improve function and maintain motion for advanced hallux rigidus.

Category: Midfoot/Forefoot Introduction/Purpose: Hallux rigidus is the most common arthritic condition of the foot. Although a variety of great toe implants have been tried in an attempt to maintain toe motion, the majority have failed. In these cases, salvage to arthrodesis is more complicated and with a prolonged recovery. This prospective study assesses the intermediate efficacy and safety of a small (8/10 mm) hydrogel implant requiring minimal bone resection for moderate to severe hallux rigidus. Methods: Patients who underwent 1st MTP hemiarthroplasty with an organic polymer-based biomaterial implant (Cartiva), with at least five-year follow-up were contacted. Patients underwent a physical exam, and completed a pain visual analog scale (VAS) scale, SF-36, patient satisfaction questions, and the Foot and Ankle Ability Measure (FAAM). Results: Twenty-nine patients were available, with two lost to follow-up. The average time of follow-up was 5.3±0.5 years. The average age was 55.6±8.4, with 24(80%) females. The average VAS for pain improved from 64.6(±11.8) to 5.2(± 9.4) (p < 0.001). The average FAAM scores were: ADL subscale: 62.1(±16.4) to 95.8%(± 7.2) (p < 0.001); and Sports subscale: 40.2(±15.1) to 91.3%(±11.2) (p < 0.001); The average FAAM scores at follow-up for: Level of function during sports: 91.9%(±10.7); and Current level of function: 92.5%(±10.6). 69.2% of patients reported their level of function as normal, 26.9% nearly normal, and 3.8% abnormal function. Patients had 17.7 degrees of dorsiflexion, with a range of 12.7 to 22.7 degrees. Average peak dorsiflexion was 28.2°(±8.8). 92.3% stated they would undergo the procedure again. Conclusion: This study reports the mid-term results of an organic polymer-based biomaterial hemiarthroplasty implant for the management of hallux rigidus. Overall patients were very satisfied with the procedure. At an average of five years, patients are functioning very well, with limited pain and maintained motion of the 1st MTP joint. These results are promising as a viable alternative to fusion of the 1st MTP joint for management of moderate to severe hallux rigidus.

Category: Ankle Arthritis Introduction/Purpose: Researchers and clinicians measuring outcomes following total ankle replacement (TAR) are challenged by the wide range of outcome measures used in the literature without consensus as to which are valid, reliable, and responsive in this population. This review identifies region- or joint-specific outcome measures used for evaluating TAR outcomes and synthesizes evidence for their measurement properties. Methods: A standard search strategy was conducted of electronic databases MEDLINE, EMBASE and CINAHL (to June 2015) to identify foot/ankle measures in use. A best evidence synthesis approach was taken to critically appraise measurement properties [COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)] of identified measures. The review was restricted to English publications and excluded cross-cultural adaptations. Measurement properties collected from each article were coded for validity, reliability, responsiveness, or interpretability. Psychometric evidence exists for identified measures tested in non-TAR populations, but were not the focus of this review. Results: The search identified five measures to include in the best evidence synthesis, which have undergone psychometric testing in a TAR population (Foot Function Index, Ankle Osteoarthritis Scale, American Orthopaedic Foot and Ankle Society Ankle- Hindfoot Scale, Foot and Ankle Outcome Score, Self-Reported Foot and Ankle Score). Methodological quality of the studies providing psychometric evidence was assessed: (1) Validity—Two good quality studies examining different measures provide moderate evidence supporting construct validity (SEFAS; FFI, AOS, AOFAS *subjective items); (2) Reliability—two good quality studies examining different measures provide moderate evidence supporting internal consistency and test-retest reliability (FFI, AOS, AOFAS*; FAOS, SEFAS); (3) Responsiveness—one fair quality study provides limited evidence for AOFAS*, AOS, FFI; (4) Interpretability—two studies provided interpretability values (AOS, FFI, AOFAS*). Conclusion: This review offers a basis for choosing the most appropriate instrument for evaluating TAR outcomes. Numerous outcome measures were identified with evidence supporting their use in populations with various foot/ankle conditions, but none have strong evidence supporting usage in a TAR population. Outcome measures must have adequate psychometric properties in all patient groups in which they are applied. Evidence supporting or critiquing an instrument should not be based on studies with poor quality methodology, as identified by this review. Further testing in a TAR population would benefit identified measures with emphasis on adequate sample sizes, testing a priori hypotheses, and evaluating their content validity for a TAR population.

Category: Ankle Arthritis Introduction/Purpose: Smoking has been shown to increase complication rates after ankle surgery. The aim of this study was to compare complication rates between smokers and non smokers undergoing surgery for ankle arthritis. Methods: Smokers (n=88) and non smokers (n=565) with ankle arthritis who had undergone ankle arthrodesis or ankle arthroplasty were included in the study. Multicentre, prospective data was used from the COFAS ankle arthritis database. Patients with information available on smoking habits and 2 year follow up were included Results: There was no significant difference in the overall re operation rates between smokers and non smokers. However, the amputation rate was higher in smokers (3.4%) as compared to non smokers (0.7%). AOS scores and SF 36 scores were similar in the 2 groups. A higher proportion of smokers underwent fusion (46.5%) as compared to non smokers (28.8%). Amputation rate after ankle arthrodesis was higher in smokers (4.9%) as compared to non smokers (0.6%). Conclusion: Smokers have a higher amputation rate after ankle arthrodesis or ankle arthroplasty as compared to non smokers. Information from this study can be used during counselling of surgical patients

Category: Ankle Arthritis Introduction/Purpose: End-stage ankle arthritis (ESAA) is a debilitating disease that does not affect all individuals equally. Gender differences have been identified in patients with end-stage hip and knee arthritis and have stimulated research to explain these findings. The present study was undertaken to examine if gender has a significant effect on pre-operative disability and post- operative outcomes in patients with ESAA. Methods: Patients undergoing ankle arthrodesis (AA) or total ankle replacement (TAR) with minimum 2-year follow-up were identified in the Canadian Orthopedic Foot and Ankle Society prospective ankle reconstruction database. Demographic data, revision data, patient satisfaction questionnaires, and outcome data using the Ankle Osteoarthritis Scale (AOS) and Short-form 36 (SF-36) health survey were collected. Results: TAR: 384 patients were included, with 198 females and 186 males. Preoperatively females had higher rates of pain and disability, demonstrated by lower SF-36 physical component scores (PCS) (31.0 vs 34.5, p < 0.001), and higher AOS pain (54.7 vs 51.1, p=0.05) and AOS disability scores (66.5 vs 59.6, p < 0.001). Postoperatively, both groups had significant improvement in PCS, AOS pain, and AOS disability scores. Females continued to demonstrate lower PCS scores (38.3 vs 41.9, p < 0.001) and higher AOS disability scores (31.0 vs 25.8, p=0.02) than males. Preoperative PCS, gender, age, and arthritis etiology all had a significant impact on postoperative PCS scores, with preoperative PCS scores having the largest impact. Gender had no significant impact on AOS pain and disability scores postoperatively. AA: Results Pending Conclusion: In patients with ESAA, females tend to have higher pre-operative levels of pain and disability compared to males, which persists post-operatively. This is consistent with the hip and knee arthroplasty literature. This finding may be due to females undergoing surgery at more advanced disease states, arthritis etiology, referral bias, or treatment bias. Both males and females have significant and similar degrees of improvement in pain and disability scores after TAR, and reoperation rates and patient satisfaction rates are similar despite the apparent disparity in outcomes.

Category: Ankle Arthritis Introduction/Purpose: There has been limited evidence to support the effective use of a patient reported outcome measure (PROM) for patients that have undergone surgical treatment for end-stage ankle arthritis (ESAA). This study used longitudinally collected patient-data from a cohort of patients in the Canadian Orthopaedic Foot and Ankle Society (COFAS) ankle arthritis study to evaluate whether the post-operative COFAS Ankle Arthritis Score (COFAS AAS), a patient-reported outcome (PROs), was associated with need for revision surgery. Methods: Between 2001 and 2010, a cohort of 623 patients and 653 ankles undergoing total ankle replacement or ankle arthrodesis were enrolled in a multicenter prospective ankle reconstruction study. At pre-surgical baseline, key patient level variables were collected including demographics, body mass index, and comorbidities. The COFAS AAS, a patient-reported outcome measure was collected at baseline and annually post-surgically. Time to revision surgery was modeled using a proportional hazards model which controlled for age, sex, BMI, diabetic status, smoking status, inflammatory arthritis, and surgery on the right or left side and time varying PROs. Results: 531 ankles in 509 patients with complete pre and post-operative data were included. Seventy of the cohort underwent metal component revision procedures during the follow up time period . The remaining 461 unrevised ankles had a minimum 2 year follow up (average of 3.4 years). Baseline COFAS AAS, age, sex, side, BMI, diabetic status, smoking status, and inflammatory arthritis were not statistically associated with the need for revision surgery. However, revision surgery was found to be associated with a higher post-operative COFAS AAS, and with a longer follow-up. The hazard ratio for the COFAS AAS indicates that for every one-point increase in the score, the rate of revision surgery was one percentage point higher at each post-operative time point. Conclusion: This study demonstrated that patients who reported higher levels of post-operative functional impairment, as indicated by a higher COFAS AAS, were more likely to undergo a revision surgery. This finding is also based on duration of follow-up, with the risk of revision surgery rising with length of follow up. This study provides further evidence for the utility of the COFAS AAS in the clinical setting. Further investigation is warranted to better understand the COFAS AAS’s ability to measure clinically meaningful change in an individual patient not requiring revision surgery.

Category: Ankle Arthritis Introduction/Purpose: Patients often comment on swelling after foot and ankle surgery. However the relationship between swelling and outcome has not been defined. Pinsker and Daniels demonstrated that swelling was an important aspect of outcome. The purpose of this paper was to determine the relationship between swelling score and outcome after ankle fusion and replacement. A secondary purpose was to determine how this relationship changed in time, how swelling score changed before and after surgery, and determine differences in swelling score between total ankle replacement (TAR), open ankle arthrodesis (OAA) and arthroscopic ankle arthrodesis (AAA). Methods: The MODEMS outcomes package from AAOS was used, with the validated ankle osteoarthritis score (AOS) score being used to assess outcomes in the pain and disability domains. The swelling score was indexed from 1 to 5, 1 being no swelling and five being severe swelling. Outcomes were recorded pre-operatively and annually up to 2010. Statistical analysis was performed using 95% confidence intervals and correlations being determined using Pearson’s correlation and r 2 values. Results: The swelling score was correlated with AOS score preoperatively. Postoperatively patients with a swelling score of 1 had an average AOS score of 15.1 (CI 13.3 to 16.9), a swelling score of 2 had an AOS score of 23 (CI 21.7 to 24.9), 3 an AOS of 31 (CI 29.6 to 33.1), 4 an AOS of 33.6 (CI 34.9 to 38.8), and 5 an AOS of 39 (CI 35.3 to 43.0). There was therefore a difference in outcome score for all groups of swelling score (i.e. 1 scored better than 2, 2 better than 3, 3 better than 4 and 4 better than 5). Swelling scores were the same for TAR, OAA and AAA preoperatively. Postoperatively swelling scores were lower for AAA (2.1, CI 1.9 to 2.2) compared to TAA (2.5, CI 2.4 to 2.6) and OAA (2.5, CI 2.4 t0 2.6). Conclusion: Swelling has a relationship with outcome. Swelling after surgery may result in poorer outcomes. Strategies to reduce swelling such as patient education about elevation, surgical technique and the use of compression stockings may improve outcomes. Arthroscopic surgery may have better outcomes because of the reduction in postoperative swelling.

Category: Ankle Arthritis Introduction/Purpose: Reoperations may be a better way of tracking adverse outcomes than complications. Repeat surgery causes cost to the system, and often indicate failure of the primary procedure resulting in the patient not achieving the expected improvement in pain and function. Understanding the cause of repeat surgery at the primary site may result in design improvements to implants or improvements to fusion techniques resulting in better outcomes in the future. Repeat operations around the primary site may also be relevant to the primary surgery. The COFAS group have designed a reoperation classification system. The purpose of this study was to outline the inter and intra observer reliability of this classification scheme. Methods: To verify the inter- and intra-observer reliability of this new coding system, six fellow ship trained practicing foot and ankle Orthopaedic surgeons were asked to classify 61 repeat surgeries. The six surgeons read the operation reports in random order, and reread the reports 2 weeks later in a different order. Reliability was determined using regression analysis and intraclass correlation coefficients (ICC) were calculated and proportions of agreement. The agreement between pairs of readings (915 for inter observer for the first and second read; 61 readings with 15 comparisons) was determined by seeing how often each observer agreed. This was repeated for the 366 ratings for intra observer readings (61 times 6). Results: The inter-observer reliability test on the first read had a mean intra-class correlation coefficient (ICC) of 0.89, range 0.80 to 0.96. For 61 cases, 45 (74%) observations that were given the same code across all six observers for the first read. The inter-observer reliability test on the second read had a mean ICC of 0.94, range .90 to to 1.0. There were 43 (72%) observations that were the same across all six observers. Of all pairs (915 in total) there was agreement in 804 pairs for the first reading (88%). For the second reading there was agreement in 801 pairs (86%). The observers agreed with themselves in the intra-observer observation 324 times out of 366 paired readings (89% agreement of pairs). Conclusion: The COFAS classification of reoperations for end stage ankle arthritis was reliable. This scheme potentially could be applied to other areas of Orthopaedic surgery and should replace the Claiden Dindo modifications that do not accurately reflect Orthopaedic outcomes. As complications are hard to define and lack consistent terminology (Mercer) reoperations and resource utilization (extra clinic visits, extra days in hospital and extra hours of surgery may be more reliable measures of the negative effects of surgery.

Background:. A recent survey of orthopaedic surgeons asking about risk factors for nonunion following foot and ankle arthrodesis revealed that patient age is considered to be a relatively low risk factor, despite the potential for autologous graft quality to deteriorate with increasing age. The purpose of the current study was to evaluate the impact of patient age and graft type on fusion rates following hindfoot and ankle arthrodesis. Methods:. In this study, we analyzed data from a previously published clinical trial, comparing fusion success in 397 subjects who underwent hindfoot or ankle arthrodesis (597 joints) supplemented with either autograft or an osteoinductive autograft alternative, recombinant human platelet-derived growth factor-BB homodimer carried in beta-tricalcium phosphate (rhPDGF-BB/β-TCP). The odds of fusion success were compared among subjects older or younger than age thresholds of 55, 60, 65, 70, and 75 years. The odds of fusion success were also compared between autograft and rhPDGF-BB/β-TCP among subjects older than each age threshold. Results:. In the autograft group, the joints of subjects who were younger than the age thresholds of 60 and 65 years had >2 times the odds of successful fusion compared with those of older subjects. There was no significant difference in the odds of fusion success between the older and younger subjects at the age threshold of 55 years. In the rhPDGF-BB/β-TCP group, there was no significant difference in the odds of successful fusion between older and younger subjects at any age threshold. When the odds of fusion success were compared between the 2 graft materials in subjects who were older than each age threshold, rhPDGF-BB/β-TCP had approximately 2 times the odds of fusion success compared with autograft for all thresholds, except 55 years. Conclusions:. The presented evidence suggests that age is an identifiable and concerning risk factor for hindfoot and ankle arthrodesis nonunion, a finding in contrast to the wider perception in the surgeon community. Notably, patients ≥60 years of age had significantly lower odds of fusion success with the use of autograft. The data reveal that use of rhPDGF-BB/β-TCP as an alternative bone-healing adjunct may help mitigate the risk of nonunion when these procedures are performed in the elderly population. Level of Evidence:. Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.