Medial Displacement Calcaneal Osteotomy and FDL Transfer Comparing Metal/Bio-Tenodesis Screw and Human Allogeneic Cortical Bone Screw (Shark Screwae)

What this Trial Is About

Researchers are comparing two types of screws used in surgery to treat symptomatic flatfoot deformity in adults. The study focuses on a human bone screw called Shark-Screwae and a metal/Bio-Tenodesis screw, assessing if the human bone screw can achieve similar bone healing, complication rates, and activity outcomes after surgery. The research is observational and aims to document clinical and imaging results systematically before and after surgical treatment involving medializing calcaneus osteotomy with transfer of the flexor digitorum longus tendon (FDL). The study involves surgical treatment where participants receive a medializing calcaneal osteotomy and FDL tendon transfer fixed with either the Shark-Screwae or the metal/Bio-Tenodesis screw. The procedures include careful bone cuts, tendon handling, and screw fixation under imaging guidance. Various screw sizes are used depending on the group. This study compares the two screws by monitoring bone union, surgical complications, and functional outcomes over time. Participants will have follow-up visits at 6 weeks, 6 months, 1 year, and 2 years after surgery. At each visit, X-rays will check bone healing, and CT scans will be done at 6 months and 1 year. Activity and pain questionnaires like the American Orthopaedic Foot and Ankle Society (AOFAS) score and Foot and Ankle Outcome Score (FAOS) will be collected at multiple time points. The study will also track complications, reoperations, and specific bone healing issues to evaluate safety and effectiveness of the screws over two years.

Medial Displacement Calcaneal Osteotomy and FDL- Transfer - With a Human, Allogeneic Cortical Bone Screw