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.
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.
None
Parallel
MagnetOs
DeviceMagnetOs will be used at a volume of approximately 1-5 cc's for the TN, CC and ST joints, and up to 10 cc's for the tibiotalar joint.
Autograft
Other interventionIn this study, the comparator is autograft and will be used at a volume of approximately 1-5 cc's for the TN, CC and ST joints, and up to 10 cc's for the tibiotalar joint.
Radiographic fusion by CT scan
The primary endpoint is the incidence of fusion at each side by CT analysis as assessed by the independent radiological expert at 24 weeks post-op
Radiographic fusion by CT scan
Joint fusion at Week 52 post-surgery assessed by CT-scans determined by an independent radiological expert panel (IREP) in patients undergoing hindfoot or ankle fusions
Radiographic Fusion by plain radiographs
Joint fusion at Week 12, Week 24 and Week 52 post-surgery assessed by plain radiographs determined by an independent radiological expert panel (IREP) in patients undergoing hindfoot or ankle fusions
Functional
Change in Foot Function Index (FFI) from Screening to Week 2, Week 6, Week 12, Week 24 and Week 52 post-surgery. The score ranging from 0% to 100% indicates the severity of a person's foot issues. A score of 100% indicates worst possible pain, while 0% indicates no pain.
Functional
Change in Visual Analog Score (VAS) from Screening to Week 2, Week 6, Week 12, Week 24 and Week 52 post-surgery. 0 no pain and 10 worst pain possible
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