Comparing MagnetOs synthetic bone graft putty with a patient's own bone for hindfoot and ankle fusions

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

This will test whether MagnetOs synthetic bone graft putty works as well as using a patient's own bone for adults undergoing hindfoot or ankle fusion surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Kuros Biosurgery AG (Industry-sponsored)
• Locations: 5 sites (Vail, Colorado and 4 other locations)
• Trial ID: NCT07225751 on ClinicalTrials.gov

What this trial studies

About 126 adults needing hindfoot or ankle fusion will be randomized 1:1 to receive either MagnetOs Putty/Easypack Putty or local autograft alongside standard rigid hardware fixation. Procedures may include tibiotalar, subtalar, calcaneocuboid, talonavicular, or selected double fusions at the surgeon's discretion. Follow-up visits include radiographs at screening and weeks 6, 12, 24, and 52, with CT scans at weeks 24 and 52 to determine the primary endpoint at 24 weeks and continued safety/efficacy monitoring to one year. MagnetOs will be applied per the approved instructions for use for the putty formulations.

Who should consider this trial

Good fit: Adults aged 18–75 who are ambulatory and require a hindfoot or ankle fusion using rigid fixation and supplemental bone graft/substitute are appropriate candidates.

Not a fit: Patients who are non-ambulatory, have prior fusion of the target joints, expect to need a secondary intervention within one year, or whose surgical technique does not use bone graft are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could provide an effective bone graft option that avoids harvesting the patient's own bone and its associated donor-site pain and complications.

How similar studies have performed: Synthetic calcium phosphate-based graft extenders like MagnetOs have shown promise in other orthopedic fusion settings, but randomized data specifically for hindfoot and ankle fusions remain limited.

Eligibility 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.

Where this trial is running

Vail, Colorado and 4 other locations

• Steadman Philippon Research Institute — Vail, Colorado, United States (Recruiting)
• Hughston Foundation Inc — Columbus, Georgia, United States (Recruiting)
• OrthoCarolina Research Institute, Inc — Charlotte, North Carolina, United States (Recruiting)
• Reconstructive Orthopaedic Associates II dba Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States (Recruiting)
• Erlanger Orthopaedics — Chattanooga, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: Cesar Silva, MD

Conditions Ankle Arthrodesis or Arthroplasty; Hindfoot Fusion; Ankle Deformity; Ankle Disease; Hindfoot Arthrodesis; Hindfoot Pathologies; ankle arthrodesis; hindfoot fusion