Evaluating Sinus Tarsi Implant with Medial Displacement Calcaneal Osteotomy for Treating Flexible Adult Flatfoot Deformity in Adults Aged 16 to 75

What this Trial Is About

Researchers are evaluating surgical treatments for adult acquired flatfoot deformity AAFD, a condition causing foot pain and changes in walking. This trial compares the standard medial displacement calcaneal osteotomy MDCO alone with MDCO combined with a sinus tarsi implant STI, which may provide better correction by supporting soft tissues and improving foot alignment. The study is a randomized controlled trial involving patients aged 16 to 75 with mobile AAFD stage II who have not improved after physiotherapy. Participants will be randomly assigned to receive either MDCO with STI or MDCO without STI. Both groups may also receive additional procedures like Strayers gastrocnemius recession, flexor digitorum longus tendon transfer, spring ligament repair, and possibly a Cotton osteotomy if needed. Surgery will be performed by experienced foot and ankle surgeons at multiple orthopedic centers. Postoperative care includes casting and weight-bearing instructions tailored to the procedures performed. Patients will be assessed before surgery and at 4-5 months, 1 year, and 2 years after surgery through clinical exams, questionnaires measuring foot function and quality of life SEFAS and EQ-5D, and weight-bearing foot X-rays to measure angles like Mearys angle. Researchers will also evaluate pain, satisfaction, heel-rise endurance, sick-leave duration, and complications. Follow-up involves blinded examiners and radiologists to ensure unbiased assessments, with patients encouraged to complete all visits and questionnaires over the two-year period.

Sinus Tarsi Implant as an Adjuvant Procedure to Medial Displacement Calcaneal Osteotomy in the Treatment of Mobile Adult Acquired Flatfoot Deformity