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”).
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.