Background: As the popularity of total ankle arthroplasty (TAA) increases and indications expand, surgeons require a better understanding of which patient factors are associated with implant failure. In this study, we aimed to use a large total ankle database to identify independent risk factors for implant failure at mid- to long-term follow-up. Methods: A prospectively collected database was used to identify all patients who underwent primary TAA with a minimum 5 years’ follow-up. The primary outcome was revision, defined as removal of one or both metal components; failures due to infection were excluded. Patient and clinical factors analyzed included age, sex, body mass index (BMI), smoking status, presence of diabetes, indication for TAA, implant, tourniquet time, and presence of ipsilateral hindfoot fusion. Preoperative coronal deformity and sagittal talar translation were assessed, as were postoperative coronal and sagittal tibial component alignment. Univariable and multivariable analyses were performed to identify predictors of implant failure. After excluding 5 ankles that failed because of deep infection, 533 ankles with a mean 7 (range, 5-11) years of follow-up met the inclusion criteria. Four implants were used: INBONE I, INBONE II, STAR, and Salto-Talaris. Results: Thirty-four ankles (6.4%) were revised or removed a mean 4 (range, 1-9) years postoperatively. The only independent predictors of failure were the INBONE I prosthesis and ipsilateral hindfoot fusion ( P = .006 and P = .023, respectively). Conclusions: This is among the largest studies to analyze the relationship between TAA failure rates and multiple different patient, operative, and radiographic factors. Of note, age, BMI, and amount of deformity were not associated with higher failure rates. Only patients with ipsilateral hindfoot fusion or who received the INBONE I prosthesis were at significantly higher risk of implant failure. Level of Evidence: Level III, retrospective cohort study.

Objective: To compare the rate of malreduction after high fibular fractures associated with syndesmosis injury treated with open reduction and internal fixation, with either 2 screws or 1 knotless TightRope device. Design: Prospective randomized controlled multicenter trial. Setting: Eleven academic and community hospitals including Level 1 and Level 2 trauma centers across Canada. Patients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability after malleolar bony fixation were followed for 12 months after treatment. Methods: Open reduction of the syndesmosis was performed in all cases. Fixation was randomized to either TightRope (1 knotless TightRope, group T) or screw fixation (two 3.5-mm cortical positional screws placed across 3 cortices, group S). Surgical techniques and rehabilitation were standardized. All surgeons were trained or experienced in the use of the TightRope device. Follow-up was performed at 2 and 6 weeks, 3, 6, and 12 months. Main Outcome Measure: Rate of malreduction based on bilateral ankle computed tomography scan results at 3 months after fixation. Secondary outcome measures included adverse events, reoperation, and validated functional outcomes including the EQ-5D, the Olerud–Molander Ankle Score, the Foot and Ankle Disability Index, and the Work Productivity Activity Impairment Questionnaire. The estimated sample size required to detect a difference in reduction rate was 72 patients, but the estimated sample size required to detect a difference in functional outcome scores was 240 patients, suggesting the study was adequately powered for radiographic results only. Results: Overall, the rate of malreduction using screw fixation was 39% compared with 15% using TightRope fixation (P = 0.028, χ2). Analysis of computed tomography results was performed using a 2-mm translation or 10-degree rotation threshold for malreduction and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, and mid); medial compression; and rotation (fibular and articular). Patients in group T had greater anterior translation (5.4 ± 1.8 mm) compared with the contralateral limb (4.3 ± 1.3 mm, P < 0.01) or group S (4.6 ± 1.5 mm, P = 0.05). Group T syndesmoses also had greater diastasis compared with control limb (4.1 ± 1.3 vs. 3.3 ± 1.4 mm, P < 0.01) and less fibular medialization compared with group S (1.04 ± 1.8 vs. 0.3 ± 1.8 mm, P = 0.05). Functional outcome measures demonstrated significant improvements over time, but no differences between fixation groups. Foot and Ankle Disability Index scores at each time interval were 44 ± 22 (T) versus 45 ± 24 (S) (6 weeks), 76 ± 14 versus 73 ± 17 (3 months), 89 ± 10 versus 86 ± 13 (6 months), and 93 ± 9 versus 90 ± 14 (12 months) (all P > 0.2). The reoperation rate was higher in the screw group compared with TightRope (30% vs. 4%, P = 0.02) with the difference driven by the rate of implant removal. Conclusions: Based on our results, the TightRope device seems to compare favorably with two, 3.5-mm, 3-cortex screw fixation for syndesmosis injuries. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Level IV, case series.