Could a Man-Made bone putty replace your own bone in ankle surgery?
NCT ID NCT07225751
First seen Jun 24, 2026 · Last updated Sep 02, 2026 · Updated 6 times
Summary
This study tests a synthetic bone graft called MagnetOs against the standard method of using a patient's own bone for ankle or hindfoot fusion. About 126 adults needing fusion surgery will be randomly assigned to receive either MagnetOs or an autograft. The main goal is to see if the synthetic graft leads to similar bone fusion on CT scans at 24 weeks, potentially offering a less painful option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MagnetOs (synthetic bone graft putty)
- What this could lead to
- If it works, this could offer a less painful alternative to using a patient's own bone for fusion surgery, avoiding a second surgical site.
- What could go wrong
- This is a relatively small, early-stage study (126 people) comparing to standard care. The synthetic graft may not fuse as reliably as the patient's own bone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 126 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centers for Advanced Orthopaedics
RECRUITINGFalls Church, Virginia, 22042, United States
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Hughston Foundation Inc
RECRUITINGColumbus, Georgia, 31909, United States
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Integrity Orthopedics and Sports Medicine
RECRUITINGChattanooga, Tennessee, 37404, United States
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OrthoCarolina Research Institute, Inc
RECRUITINGCharlotte, North Carolina, 28207, United States
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Reconstructive Orthopaedic Associates II dba Rothman Orthopaedic Institute
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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Steadman Philippon Research Institute
RECRUITINGVail, Colorado, 81657, United States
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University California Davis
RECRUITINGSacramento, California, 95816, United States
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