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Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery

This study is testing a new type of screw called the RemeOs magnesium-based screw for fixing unstable ankle fractures. Currently, metal screws are used, but they can cause irritation or need a second surgery to remove them. The RemeOs screws are designed to slowly dissolve in your body over two to three years, so you might not need another surgery. We are looking for 28 participants between 18 and 80 years old who have an unstable ankle fracture requiring surgery. The main goal is to see how well your ankle recovers after 12 months, using a score called the Olerud-Molander Ankle Score (OMAS). The study status is unclear, but it is actively enrolling participants.

Study design
This is a single-arm study, meaning all participants will receive the RemeOs magnesium-based screws. It plans to enroll 28 participants.
What's involved
You would need to follow postoperative visits and rehabilitation protocols, and be able to complete patient-reported outcome measures.
Compensation
Not stated in the trial record.
Follow-up
Your ankle recovery will be measured at 12 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07693933

Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery

Not Yet Recruiting
NAAges 18–80InterventionalTreatment
Massachusetts General Hospital
~28 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:RemeOs Magnesium-Based Biodegradable Screw

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Olerud-Molander Ankle Score (OMAS)
Measured over 12 months

Conditions

Ankle Fractures
Syndesmotic Injury

Explore related trials

Ankle Fracture

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Mani Eftekhari, BS
[email protected]
15108506056
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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

What this trial measures

  • Olerud-Molander Ankle Score (OMAS)12 months

    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.