A Prospective, Randomized, Single-blind, Controlled, Multi-center Study to Assess the Safety and … (NCT07225751) | Clinical Trial Compass
RecruitingNot Applicable
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.
United States126 participantsStarted 2025-11-25
Plain-language summary
This is a phase IV post-marketing study for MagnetOs Putty and MagnetOs Easypack Putty. MagnetOs is a synthetic bone graft extender product that is routinely used by surgeon as treatment for hindfoot and ankle disorders.
In this study, MagnetOs Putty and MagnetOs Easypack Putty will be use according to the latest Instructions For Use, standalone in the foot and ankle.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent.
✓. Male or female patient ≥ 18 (considered skeletally mature) up to and including 75 years old
✓. Patients requiring one of the following hindfoot fusion procedures, using surgical technique, necessitating rigid hardware fixation and supplemental bone graft/ substitute: ankle fusion (tibiotalar) subtalar fusion (talocalcaneal), calcaneocuboid fusion, talonavicular fusion, OR double fusion (any combination of any two of the following: subtalar, talonavicular and calcaneocuboid joints).
✓. Hardware parameters - rigid fixation using screws, plates, staples, nails or a combination.
Exclusion criteria
✕. Expected to need secondary intervention within one year following surgery.
✕. Had prior fusion or attempted fusion of the joints to be fused.
✕. Patient is not ambulatory.
✕. Surgical technique where bone graft is not expected to be used.
✕. Conditions at the surgeon's discretion in which general bone grafting is not advisable.
✕. Radiographic evidence of fractures or pathologies around the fusion that could negatively impact the fusion process (e.g., growth plate fracture around the fusion or bone cysts).
✕. Significant vascular impairment proximal to the graft site.