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.

Inclusion Criteria

• •Inclusion:
• •1. Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent.
• •2. Male or female patient ≥ 18 (considered skeletally mature) up to and including 75 years old
• •3. 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).
• •4. Hardware parameters - rigid fixation using screws, plates, staples, nails or a combination.
• •Exclusion:
• •1. Expected to need secondary intervention within one year following surgery.
• •2. Had prior fusion or attempted fusion of the joints to be fused.
• •3. Patient is not ambulatory.
• •4. Surgical technique where bone graft is not expected to be used.
• •5. Conditions at the surgeon's discretion in which general bone grafting is not advisable.
• •6. 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).
• •7. Significant vascular impairment proximal to the graft site.
• •8. Acute and/or chronic infections in the operated area (soft tissue infections; bacterial bone diseases; osteomyelitis)
• •9. Pre-existing sensory impairment (e.g. diabetes, Charcot). Diabetics patients with HbA1c greater than 7.0 OR that were not sensitive to the 5.07 monofilament will be excluded.
• •10. Metabolic disorders know to adversely affect the skeleton (e.g., renal osteodystrophy or hypercalcemia).
• •11. If intraoperative soft tissue coverage is not planned or possible.
• •12. Receiving treatment with medication interfering with calcium metabolism (chronic use of glucocorticoid and use high dose NSAIDs 800 mg TID for \> the first 6 weeks post-op).
• •13. Has benign or malignant tumor at the surgical site.
• •14. Has history or presence of active malignancy (non-invasive skin cancer is allowed).
• •15. Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements (e.g. prisoners, physically or mentally compromised, etc.).
• •16. Is involved in active litigation relating to his/her foot and ankle condition.
• •17. Participation in an investigational study within 30 days prior to surgery for study devices.
• •18. Patient with body mass index (BMI) \> 50.
• •19. Patient cannot comply with all post-operative evaluation and visits .
• •20. Any pre-existing condition that the surgeon determines could interfere with the patient's ability to perform objective functional measurements.
• •21. Women who are or intend to become pregnant within the next 12 months.