Study Comparing Safety and Effectiveness of MagnetOs Putty Versus Autograft in Adults Undergoing Hindfoot or Ankle Fusion Surgery

What this Trial Is About

This research aims to assess the safety and performance of MagnetOs Putty and MagnetOs Easypack Putty, synthetic bone graft extenders, compared to autogenous bone graft in patients undergoing hindfoot or ankle fusions. The study focuses on treating hindfoot and ankle disorders requiring rigid hardware fixation and supplemental bone graft or substitute. It is a randomized, single-blind, controlled, multi-center phase IV post-marketing study involving adult patients aged 18 to 75 years. Participants will be randomly assigned to receive either MagnetOs PuttyEasypack Putty or autograft harvested from the calcaneus, distal tibia, or proximal tibia along with rigid hardware fixation during surgery. The volume used depends on the joint fused, with 1-5 cc for talonavicular, calcaneocuboid, and subtalar joints, and up to 10 cc for the tibiotalar joint. The surgical procedures include ankle fusion, subtalar fusion, calcaneocuboid fusion, talonavicular fusion, or double fusion of two of these joints. Participants will be followed up with radiographs at screening and weeks 6, 12, 24, and 52 post-surgery, with CT scans at weeks 24 and 52 to evaluate radiographic fusion. Functional assessments will also be conducted throughout the study period. If secondary surgical interventions occur after six months, CT scans may be adjusted. The primary outcome is radiographic fusion by CT scan at 24 weeks post-operation. Safety and efficacy are monitored for one year after surgery, with weight-bearing X-rays starting at week 12.

A Prospective, Randomized, Single-blind, Controlled, Multi-center Study to Assess the Safety and Performance of MagnetOsTM Compared to Autogenous Bone Graft in Patients Undergoing Hindfoot or Ankle Fusions.