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NCT07693933 · ClinicalTrials.gov registry record · NA
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
A NA study, sponsored by Massachusetts General Hospital.
- Not yet
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT07693933: Clinical Trial NA study, sponsored by Massachusetts General Hospital.
NCT07693933 is a NA study that has not yet begun recruiting, run by Massachusetts General Hospital. The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07693933, a NA study, has not yet begun recruiting, sponsored by Massachusetts General Hospital.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study Summary
Ankle fractures are among the most common injuries that need surgery. When the broken bones make the ankle unstable, surgeons usually fix them with metal screws and plates. Metal hardware holds the bones in place well, but it can cause irritation, can loosen or break, and often has to be removed in a second surgery later. This study looks at a different kind of screw called the RemeOs magnesium-based screw. It is made from a magnesium alloy and is designed to slowly dissolve and be absorbed by the body over about two to three years after it has done its job of holding the bone together. Because it dissolves on its own, patients may not need a second surgery to remove the hardware. These screws are authorized by the U.S. Food and Drug Administration (FDA) for use in foot and ankle fracture surgery. The purpose of this study is to learn how well these magnesium screws work and how safe they are when used to repair unstable ankle fractures. The study will enroll at least 25 adults (ages 18 to 80) who have an unstable ankle fracture that needs surgery. All participants will have their fracture repaired with RemeOs screws as part of their normal surgical care. After surgery, participants will be followed for 12 months. They will return for check-ups at about 6 weeks, 3 months, 6 months, and 12 months. At these visits, the study team will examine the ankle, take X-rays to see how the bone is healing and how the screws are dissolving, ask about any complications, and have participants fill out questionnaires about their ankle function and pain. The main thing the study measures is ankle function at 12 months, scored using a standard ankle questionnaire (the Olerud-Molander Ankle Score). The study also tracks pain, healing on X-rays, how the screws break down over time, and any complications such as infection, loss of fixation, non-healing, or the need for additional surgery. The surgery, X-rays, and follow-up visits in this study are the same care patients would recei
Interventions
- DEVICE RemeOs Magnesium-Based Biodegradable Screw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2026-08 |
| Est. Completion | 2029-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07693933
The ClinicalTrials.gov registry entry for NCT07693933 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RemeOs Magnesium-Based Biodegradable Screw is the first listed.
NCT07693933 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07693933 about?
NCT07693933 is a clinical study titled "Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery". Ankle fractures are among the most common injuries that need surgery. When the broken bones make the ankle unstable, surgeons usually fix them with metal screws and plates. Metal hardware holds the bones in place well, but it can cause irritation, can loosen or break, and often has to be removed in ...
What is the current status of trial NCT07693933?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 28 participants. The study started on 2026-08. Estimated completion is 2029-03.
What interventions are being tested in trial NCT07693933?
The interventions under investigation include: RemeOs Magnesium-Based Biodegradable Screw (DEVICE).
Who is sponsoring clinical trial NCT07693933?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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