Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery

NCT07693933 | Not Yet Recruiting

• 1 other identifier: 2026P000142
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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 medial malleolus ankle fractures. In this study, they are being used as an off-label indication. 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.

Conditions

Ankle Fractures; Syndesmotic Injury

Keywords

Magnesium-based screw; Biodegradable implant

Outcome Measures

Primary Outcomes (1)

• Olerud-Molander Ankle Score (OMAS)

  Functional recovery assessed by the Olerud-Molander Ankle Score, a patient-reported instrument scored 0 to 100, where 0 indicates totally impaired and 100 indicates no impairment. Higher scores indicate better ankle function.

  12 months

Secondary Outcomes (5)

• Radiographic Fracture Healing and Alignment

  6 weeks, 3 months, 6 months, and 12 months postoperatively

• Radiographic RemeOs Screw Biodegradation

  3 months, 6 months, and 12 months postoperatively

• Complication Rate

  12 months

• Pain Intensity

  Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively

• PROMIS

  Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively

Study Arms (1)

RemeOs Magnesium Screw Fixation

EXPERIMENTAL

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.

Device: RemeOs Magnesium-Based Biodegradable Screw

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.

RemeOs Magnesium Screw Fixation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• Unstable closed ankle fracture requiring surgical fixation, including unimalleolar, bimalleolar, bimalleolar-equivalent, or trimalleolar fractures
• Fractures may be with or without syndesmotic instability
• Willingness to follow postoperative visits and rehabilitation protocols
• Ability to complete patient-reported outcome measures (PROMs)

You may not qualify if:

• Body mass index (BMI) \> 40
• Open fractures
• Pathologic fractures
• Active infection at the surgical site
• Known allergy or hypersensitivity to magnesium or implant components
• Severe peripheral vascular disease
• Uncontrolled diabetes mellitus
• Prior ankle surgery on the affected limb
• Concomitant osteochondral lesions requiring treatment
• Neuromuscular disorders affecting the lower extremity
• Worker's compensation cases
• Pregnancy
• Non-adherence concerns or inability to comply with follow-up requirements

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Bioretec Ltd.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Ankle Fractures; Ankle Injuries

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Mani Eftekhari, BS

CONTACT

15108506056; meftekhari@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Foot & Ankle Research and Innovation Lab (FARIL)

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)