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Could a Man-Made bone putty replace your own bone in ankle surgery?

NCT ID NCT07225751

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 126 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Centers for Advanced Orthopaedics

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Hughston Foundation Inc

    RECRUITING

    Columbus, Georgia, 31909, United States

  • Integrity Orthopedics and Sports Medicine

    RECRUITING

    Chattanooga, Tennessee, 37404, United States

  • OrthoCarolina Research Institute, Inc

    RECRUITING

    Charlotte, North Carolina, 28207, United States

  • Reconstructive Orthopaedic Associates II dba Rothman Orthopaedic Institute

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Steadman Philippon Research Institute

    RECRUITING

    Vail, Colorado, 81657, United States

  • University California Davis

    RECRUITING

    Sacramento, California, 95816, United States

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