Four-year outcomes following triplanar tarsometatarsal arthrodesis with early weightbearing for Hallux Valgus: A multicenter prospective study

BACKGROUND: Traditional hallux valgus surgery has been focused on two-dimensional repair with high reported recurrence rates. PURPOSE: We report the 4-year interim analysis of a prospective, 5-year, multicenter study of radiographic, clinical, and patient-reported outcomes following triplanar first tarsometatarsal arthrodesis with early weightbearing. STUDY DESIGN: This is a prospective, multicenter, clinical trial involving 7 US-based centers and 13 surgeons. One-hundred and seventy-three patients were treated, of whom 139 (80.3%) achieved their 48-month visit. Clinical and radiographic parameters were evaluated at all follow-up visits along with patient-reported outcomes [Visual Analog Scale (VAS), Manchester-Oxford Foot Questionnaire (MOxFQ) and Patient-Reported Outcomes Measurement Information System (PROMIS). METHODS: Institutional review board approval was obtained for each study site. A consecutive cohort of patients were enrolled from November 2018 to April 2021 who received first TMT arthrodesis to correct their symptomatic hallux valgus. Inclusion and exclusion criteria were established. RESULTS: Significant improvements in triplanar radiographic correction (hallux valgus angle, intermetatarsal angle, tibial sesamoid position, sagittal-plane IMA, and osseous foot width) were maintained at all timepoints. Using recurrence definitions of > 15° and 20° postoperative hallux valgus angle, recurrence rates were 8.4% (95% CI:4.27%, 14.53%) and 0.8% (95% CI:0.02%, 4.18%) at 48 months, respectively. Mean (95% CI) time to weightbearing in a boot walker was 7.7 (6.6, 8.8) days. CONCLUSION: The 4-year interim results of this prospective, multicenter study demonstrate favorable improvement of the triplanar hallux valgus deformity, maintenance of correction, low complication rate, and favorable patient-reported outcomes with early return to protected weightbearing.