Prospective multicenter study assessing radiographic and patient outcomes following an instrumented mini-open triplanar tarsometatarsal arthrodesis with early weightbearing.

This prospective, multicenter study assessed the radiographic, clinical, and patient-reported outcomes for hallux valgus (HV) correction performed with an instrumented 1st tarsometatarsal (TMT) system through a mini-open incision (≤4cm) with a biplanar plating construct and early return to weightbearing. One hundred and five patients were treated, with 75 and 11 patients completing their 12- and 24-month visits, respectively. The median (min, max) length of the primary dorsal incision was 3.5 cm (3.0, 4.0). Patients underwent an early weightbearing protocol with mean (95 % CI) of 7.9 (6.7, 9.1) days to weightbearing in a CAM boot. Significant improvements from baseline in mean radiographic measurements for Hallux Valgus Angle (HVA), Intermetatarsal Angle (IMA), Tibial Sesamoid Position (TSP), and osseous foot width (OFW) were maintained through 12 months. Using recurrence definitions of greater than 15° and 20° postoperative HVA, recurrence rates were 5.5 % (95 % CI: 1.5 %, 13.4 %) and 0.0 % at 12 months and 0.0 % for both thresholds at 24 months, respectively. Significant improvements in patient-reported outcomes [Visual Analog Scale (VAS), Manchester-Oxford Foot Questionnaire (MOxFQ) and Patient-Reported Outcomes Measurement Information System (PROMIS)] were maintained through 12 and 24 months. A clinically meaningful assessment of the scar appearance was observed in the POSAS scores. One (1.0 %) patient in the overall treated cohort of 105 required reoperation for removal of hardware due to pain. The results of this prospective, multicenter study on a mini-open 1st TMT system demonstrated improvements in radiographic correction, low recurrence, early return to activity with low complication rates, and improvements in patient-reported outcomes.