Interim Analysis of Mini3D™ Prospective Multicenter Study
Assessing Radiographic and Patient Outcomes Following the Lapiplasty® Mini-Incision Procedure
Interim data from the Company’s Mini3D™ prospective, multicenter study was presented in a poster presentation at ACFAS titled “Interim Analysis of a Prospective Multicenter Study Assessing Radiographic and Patient Outcomes Following a Mini-Open Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing.” This poster presentation included data from 103 enrolled patients and demonstrated favorable clinical and patient-reported outcomes with a mini-incision approach (median incision length: 3.5cm) at an average follow-up time of 7.4 months post-procedure, including:
- Early return to weight-bearing in a walking boot at an average of 7.8 days;
- Maintenance of radiographic correction (IMA, HVA, TSP) through 12 months;
- Significant reduction in pain (VAS) and significant improvement in patient reported outcomes (MOxFQ) through 12 months; and
- Favorable scores for scar quality using the Patient and Observer Scar Assessment Scale (“POSAS”).
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The ACFAS 2024 Scientific Poster is accessible here, which includes additional details such as patient demographics, inclusion/exclusion criteria, and complications reported in the study.