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ALIGN3D™ Interim Clinical Data
Three Year Interim Analysis of a Five-Year Multicenter Study Assessing Radiographic and Patient Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing1
Daniel J Hatch, Paul Dayton, Deidre Kile, JP McAleer, Robert D Santrock
The scientific poster includes an interim analysis of 128 patients from the ALIGN3D™ study with at least 24 months of follow-up following the Lapiplasty® Procedure demonstrating:
- Early return to weight bearing in a walking boot at an average 8.1 days;
- 99.1% maintenance of correction in radiographic measures of 3-dimensional bunion correction at 24 months (n=118) and a recurrence rate of 0.9%2
- 80.8% reduction in pain measured using the Visual Analog Scale (“VAS”) at 24 months (n=128);
- 92% and 90% improvement in walking/standing and social interaction patient-reported quality of life measures, respectively, using the Manchester-Oxford Foot Questionnaire (MOxFQ) through 36 months (n=41); and
- 97.3% of patients reporting they were satisfied or very satisfied with overall results of the procedure at 36 months (n=37).
The ACFAS Scientific Poster is accessible here, which includes additional details such as patient demographics, inclusion/exclusion criteria, and complications reported in the study.
0.9% of patients (1 out of 114 patients) demonstrated radiographic recurrence at 24 month follow up timepoint. 1.4% of patients (2 out of 144 patients) demonstrated radiographic recurrence at 12 month follow up timepoint.