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Category: Bunion; Midfoot/Forefoot Introduction/Purpose: The majority of hallux valgus (HV) corrections have been historically performed via a two-dimensional, transverse plane-focused approach, which has demonstrated high long-term recurrence rates. Recent research demonstrates that 87% of HV deformities are three-dimensional with abnormal frontal-plane rotation of the metatarsal, which cannot be completely addressed with a two-dimensional metatarsal osteotomy alone. While correction at the 1st tarsometatarsal (TMT) joint may provide the optimal surgical approach for 3D anatomic restoration at the apex of the deformity, 1st TMT fusion historically entails an extended period of non-weightbearing. This study evaluated the clinical, radiographic, and patient-reported outcomes in patients undergoing instrumented triplanar 1st TMT arthrodesis (TMTA) with a biplanar plating system and protected near- immediate weightbearing. Methods: A prospective multicenter study that will continue for 60 months post-operatively. Patients 14-58 years old with symptomatic HV (intermetatarsal and HV angles between 10-22° and 16-40°, respectively) and no prior HV surgery on the operative foot were eligible for this study. Patients were treated with an instrumented TMTA procedure using a biplanar plating system with protected early weightbearing. The primary endpoint of this study is radiographic recurrence of HV deformity at 24 months for subjects with successful correction (defined as IMA < 9°, HVA < 15° and TSP ≤ 3 at 6 weeks post-procedure). Recurrence is defined by any two of the three conditions: IMA of ≥12°, HVA ≥20° and TSP ≥4. Secondary outcomes (return to weightbearing and activities, pain measured by visual analog scale (VAS), Manchester-Oxford Foot Questionnaire (MOxFQ), and Patient Reported Outcomes Measurement Information System (PROMIS)) were evaluated post-operatively. Two independent fellowship trained musculoskeletal radiologists reviewed all radiographic data. Results: 173 patients underwent TMTA with mean age of 41.0 (range:14-58) years; 92% females. Median (range) time-to-follow-up is 25 (1.5-49.2) months. Eighteen (10.4%) patients have discontinued. Mean (SD) days to protected weightbearing in CAM boot and return to full work were 8.4 (7.4) and 57.9 (46.2), respectively. At 24 months post-procedure, 99.3% (134/135) of patients were recurrence-free. Statistically significant improvements from baseline in HVA, IMA, and TSP (Table 1), VAS score, MOxFQ and PROMIS domains were observed as early as 6 weeks post-operatively and maintained over time. In 143 patients, mean (95% CI) 24-month improvements were VAS: 3.9 (3.5, 4.2); Walking/Standing (MOxFQ): 39.2 (34.9, 43.4); Physical Function (PROMIS): 9.7 (8.3, 11.2). Nineteen (11.0%) patients experienced hardware complications yet maintained radiographic correction. Conclusion: The results of this study’s primary and secondary endpoints provide supporting evidence that TMTA with biplanar plating is successful in correcting the 3D hallux valgus deformity with early return to weightbearing and low recurrence while demonstrating favorable clinical and patient-reported outcomes. Patients exhibited meaningful pain reduction after surgery and were able to return to full, unrestricted work and activities in less than two months, on average. Statistically significant improvements in patients’ health-related quality-of-life were observed through 36 months, post-operatively. Patients will continue to be followed for up to 60 months with additional evaluations for complications, recurrence, and patient satisfaction.

Category: Bunion; Midfoot/Forefoot Introduction/Purpose: The majority of hallux valgus corrections are performed via a two dimensional approach with 1st metatarsal osteotomy and translation in the transverse plane. This approach has demonstrated high long-term recurrence rates. Recent research demonstrates that 87% of hallux valgus deformities are three-dimensional with abnormal frontal-plane rotation of the metatarsal, which cannot be completely addressed with a two dimensional metatarsal osteotomy alone. While correction at the 1st tarsometatarsal (TMT) joint may provide the optimal surgical approach for 3D anatomic restoration at the apex of the deformity, 1st TMT fusion historically entails an extended period of non-weightbearing. This study evaluated the clinical, radiographic, and patient-reported outcomes in patients undergoing instrumented triplanar 1st TMT arthrodesis (TMTA) with a biplanar plating system and protected near-immediate weightbearing. Methods: This is a prospective multicenter study that will continue for 60 months post-operatively. Patients between 14-58 years old with symptomatic hallux valgus (intermetatarsal and hallux valgus angles between 10.0-22.0° and 16.0-40.0°, respectively) and no prior hallux valgus surgery on the operative foot were eligible for this study. Patients were treated with an instrumented TMTA procedure using a biplanar plating system with protected near-immediate weightbearing. Several outcomes (radiographic, return to weightbearing and activities, pain measured by visual analog scale (VAS), Manchester-Oxford Foot Questionnaire (MOxFQ), and Patient Reported Outcomes Measurement Information System (PROMIS)) were evaluated post-operatively. Two independent fellowship trained musculoskeletal radiologists reviewed all radiographic data. These interim results are limited to patients completing at least 6 months of follow-up. Results: 165 patients underwent TMTA with at least 6 months follow-up (mean (SD): 17.8 (7.7); min, max: 5.8, 37.3). Mean age was 41.0 (range:14-58) years; 91.5% of patients were female. Mean (SD) days to protected weightbearing in CAM boot and return to full work were 8.4 (7.7) and 56.8 (45.6), respectively. Significant improvements from baseline in HVA, IMA, and TSP (Table 1), VAS score, MOxFQ and PROMIS domains were observed as early as 6 weeks post-procedure. At 12 months, mean (95% CI) change in VAS was -3.7(-4.0, -3.3); Walking/Standing (MOxFQ) change was -35.2 (-39.6, -30.8); and Physical Function (PROMIS) change was 8.7 (7.1, 10.3). Fifteen (9.1%) patients experienced hardware complications, yet maintained radiographic correction to date. No patients (0/58) with 24 months follow-up have experienced recurrence. Conclusion: These interim findings support that TMTA with biplanar plating is successful in correcting the 3D hallux valgus deformity with early return to weightbearing while demonstrating favorable clinical and patient-reported outcomes. Patients exhibited meaningful pain reduction after surgery and were able to return to full, unrestricted work and activities in less than two months, on average. Statistically significant improvements in patients' health-related quality of life were observed at 6 and 12 months, post-operatively. Patients will continue to be followed for up to 60 months with additional evaluations for complications, 24-month recurrence, and patient satisfaction.

Category: Bunion; Midfoot/Forefoot Introduction/Purpose: The pathogenesis of the hallux valgus deformity is still poorly understood. Consistent observations of the 1st tarsometatarsal (TMT) joint as the CORA of hallux valgus raises questions about pathology associated with that joint. Mason and Tanaka studied the 1st TMT joint in cadaveric specimens in 2012, observing three morphological subtypes to the 1st cuneiform articular surface. They noted that specimens with hallux valgus had either a unifacet (37%) or bifacet (63%) appearance, where normal feet had a trifacet appearance. This observation suggests that these bony differences may be responsible for 'instability' that generates the metatarsal deviation into varus, and thus the development of hallux valgus. If true, surgical corrections for hallux valgus deformity should address this TMT joint pathology. Methods: This study was designed to correlate the morphological differences of the TMT joint with symptomatic hallux valgus patients who are seeking surgery. The hypothesis was that the hallux valgus patients would show a majority unifacet and bifacet morphology and have an inclination towards unifacet in younger patients and patients with a larger deformity. The cohort of patients who are in the registered longitudinal study Align3D had their TMT joints harvested in a standard fashion as part of their surgical treatment. These specimens were analyzed for the number of facets by the surgeon at the time of their surgical procedure. This cohort therefore only includes symptomatic hallux valgus patients and eliminates hallux valgus associated with metatarsus adductus. Standard weight-bearing x-rays taken pre-operatively were analyzed for severity of deformities. Functional and Patient Reported Outcome measures were obtained pre-operatively and post-operatively. Results: In this study we observed 143 specimens. Unifacet was observed in 116 specimens (81.1%), bifacet was observed in 26 specimens (18.2%), and trifacet was observed in 1 specimen. Neither X-Ray findings, age, nor Functional Scores suggested a trend in severity in relation to morphological type. Mason & Tanaka's cadaveric study was limited in some respects because of the hardening effect of formaldehyde preservations. Their study represented an elderly population, mean age 86 years, whereas this study represented a much younger population, mean age 40.6, in which patients were able to participate in both X-Ray and clinical scoring. To the best of our knowledge, this is the first time that morphology of the TMT joint has been studied in symptomatic hallux valgus patients who underwent surgery. Conclusion: Symptomatic hallux valgus deformities are associated with a higher likelihood of having a unifacet morphology than previously reported in cadavers (81.1% vs 37%). This morphology may predispose patients to decreased stability resulting in more symptomatic deformity. The number of facets does not seem to correlate with severity of deformity on X-Ray evaluation, nor does it correlate with age. However, the younger age group in our study as compared to Mason and Tanaks's study suggests that morphological differences may even be congenital, leading to later development of deformity.

Category: Bunion; Midfoot/Forefoot Introduction/Purpose: The majority of hallux valgus corrections are performed via a two dimensional approach with 1st metatarsal osteotomy and translation in the transverse plane. This approach has demonstrated high long-term recurrence rates. Recent research demonstrates that 87% of hallux valgus deformities are three-dimensional with abnormal frontal-plane rotation of the metatarsal, which cannot be completely addressed with a two dimensional metatarsal osteotomy alone. While correction at the 1st tarsometatarsal (TMT) joint may provide the optimal surgical approach for 3D anatomic restoration at the apex of the deformity, 1st TMT fusion entails an extended period of non-weightbearing. This study evaluated the clinical, radiographic, and patient-reported outcomes in patients undergoing instrumented triplanar 1st TMT arthrodesis (TMTA) with a biplanar plating system and protected near-immediate weightbearing. Methods: This is a prospective multicenter study that will continue for 60 months post-operatively. Patients between 14-58 years old with symptomatic hallux valgus (intermetatarsal and hallux valgus angles between 10.0-22.0° and 16.0-40.0°, respectively) and no prior hallux valgus surgery on the operative foot are eligible for this study. Patients are treated with an instrumented TMTA procedure using a biplanar plating system with protected near-immediate weightbearing. Several outcomes (radiographic, range of motion (ROM), return to weightbearing and activities, pain measured by visual analog scale (VAS), Manchester-Oxford Foot Questionnaire (MOxFQ), and Patient Reported Outcomes Measurement Information System (PROMIS)) are evaluated post- operatively. Two independent fellowship trained musculoskeletal radiologists reviewed all radiographic data. These interim results are limited to patients completing at least 6 months of follow-up. Results: At time of analysis, 121 patients had undergone TMTA with at least 6 months of follow-up. Mean age was 40.6 (range:15- 58) years, and 91% of patients were female. Mean (SD) days to protected weightbearing in CAM boot, return to work, and return to full work were 8.2 (6.8), 24.0 (29.5), and 51.2 (44.0), respectively. Significant improvements (p

Category: Bunion; Midfoot/Forefoot Introduction/Purpose: The majority of hallux valgus corrections are performed via a uniplanar metatarsal osteotomy approach in which the metatarsal is cut and shifted over in the transverse plane. This approach has demonstrated high long-term recurrence rates. Recent research demonstrates that 87% of hallux valgus deformities are three-dimensional with abnormal frontal-plane rotation of the metatarsal, which cannot be fully addressed with a uniplanar metatarsal osteotomy. While correction at the 1st tarsometatarsal (TMT) joint may provide the optimal surgical approach for 3D anatomic restoration at the apex of the deformity, 1st TMT fusion has historically involved an extended period of non-weightbearing. This study evaluates the clinical, radiographic, and patient-reported outcomes in patients undergoing instrumented triplanar 1st TMT arthrodesis (TTA) with a biplanar plating system and protected near-immediate weightbearing. Methods: This is a prospective multicenter study that will continue for 60 months post-operatively. Patients between 14-58 years old with symptomatic hallux valgus (intermetatarsal and hallux valgus angles between 10.0-22.0° and 16.0-40.0°, respectively) and no prior hallux valgus surgery on the operative foot are eligible for this study. Patients are treated with an TTA procedure using a biplanar plating system with protected near-immediate weightbearing. Outcomes (radiographic, range of motion (ROM), pain measured by visual analog scale (VAS), Manchester-Oxford Foot Questionnaire (MOxFQ), return to weightbearing and activities) are evaluated post-operatively. Two independent musculoskeletal radiologists reviewed radiographic data. These interim results are limited to patients completing at least 6 weeks of follow-up. Results: At time of data cut-off, 74 patients had undergone TTA with at least 6 weeks follow-up. The majority of patients were women (95%) with mean age 41.7 years. The mean (95% confidence interval) time to protected weightbearing in CAM boot was 8.0 (6.4, 9.7) days, return to work was 19.0 (13.6, 24.4) days, and return to full work was 31.5 (22.7, 40.2) days. There was a significant change in radiographic measures pre vs. post procedure and changes were maintained over time (Table). VAS pain score decreased 4 and 6 months post-procedure by 3.9 (3.2, 4.6) and 4.2 (3.5, 5.0), respectively. The mean MOxFQ Index Score pre-procedure was 53.3 (49.5, 57.1) and at month 6 had decreased to 18.6 (12.9, 24.2). Conclusion: These interim findings support that TTA with biplanar plating is successful in correcting the 3D hallux valgus deformity with early return to weightbearing and demonstrated favorable clinical and patient-reported outcomes. Patients were able to return to full, unrestricted work and activities within just a few months and had meaningful pain reduction after surgery. Patients will continue to be followed for up to 60 months. Clinical/radiographic healing at 12 months and recurrence rates at 24 months, as well as complications and patient satisfaction, will be evaluated.