Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery

Conditions

• Ankle Fractures
• Syndesmotic Injury

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• RemeOs Magnesium-Based Biodegradable Screw — DEVICE
  ORIF performed using RemeOs magnesium-alloy biodegradable screws (Screw LAG, Screw COM, Screw FT, and/or Screw LAG Solid) for fixation of any malleolus and/or for syndesmotic fixation where indicated, per the device Instructions for Use. The screws provide mechanical stability during healing and gradually biodegrade over approximately 2-3 years, eliminating the need for routine hardware removal.

Study Details

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 receive whether or not they take part. The only research-specific parts are giving consent and filling out the study questionnaires. Taking part is voluntary and does not change the care a patient receives.

Key Dates

First listed

Jul 9, 2026

Start date

Aug 31, 2026

Status verified

Jul 2026

Primary completion

Feb 28, 2029

Completion

Mar 31, 2029

Study Design

Enrollment

28 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: RemeOs Magnesium Screw Fixation
  All participants undergo open reduction and internal fixation (ORIF) of their unstable ankle fracture using RemeOs magnesium-based biodegradable screws for fracture fixation and/or syndesmotic stabilization, in accordance with the device Instructions for Use. Screw type is selected at the surgeon's discretion. Additional fracture components may be supplemented with plates, K-wires, or non-resorbable screws as clinically indicated. Participants are followed for 12 months postoperatively.

Primary Outcome Measure

Olerud-Molander Ankle Score (OMAS) [ Time Frame: 12 months ]

Central Contacts

• Mani Eftekhari, BS
  15108506056
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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