Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Magnesium-Based Screws for Syndesmotic Fixation in Unstable Ankle Fractures
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Background: A substantial proportion of operatively treated lower-extremity injuries are ankle fractures, including unimalleolar, bimalleolar, bimalleolar-equivalent, and trimalleolar patterns, often with associated distal tibiofibular syndesmotic instability. Conventional metallic fixation provides reliable initial stability but carries well-recognized drawbacks, including hardware irritation, implant breakage or loosening, and the frequent need for secondary removal procedures-particularly for syndesmotic screws. Magnesium-based biodegradable implants are designed to provide sufficient mechanical stability during fracture healing while gradually degrading, thereby eliminating routine hardware removal. RemeOs magnesium-based screws (Bioretec), composed of a magnesium-calcium-zinc alloy, medial malleolus ankle fractures and are absorbed over approximately 2 to 3 years.
Design: This is a prospective, single-arm, interventional, post-market clinical follow-up study. A minimum of 25 patients (planned enrollment of 28 to allow for attrition) will be enrolled at participating Mass General Brigham sites. Fellowship-trained orthopaedic foot and ankle surgeons will perform all procedures.
Intervention: All participants will undergo open reduction and internal fixation (ORIF) of their ankle fracture using RemeOs magnesium-based biodegradable screws for fracture fixation and/or syndesmotic stabilization, in accordance with the device Instructions for Use. RemeOs screw types (Screw LAG, Screw COM, Screw FT, and Screw LAG Solid) may be used at the surgeon's discretion. Fixation of additional fracture components may be supplemented with plates, K-wires, or non-resorbable screws as clinically indicated.
Assessments: Participants are evaluated preoperatively (baseline characteristics, radiographs, and patient-reported outcomes) and postoperatively at 6 weeks, 3 months, 6 months, and 12 months, with an optional 9-month visit if delayed healing or complications are suspected. Each follow-up includes clinical examination, radiographic assessment of healing and screw biodegradation, complication assessment, and patient-reported outcomes.
Primary outcome: Functional recovery measured by the Olerud-Molander Ankle Score (OMAS) at 12 months.
Secondary outcomes: OMAS at 3 and 6 months; radiographic fracture healing and alignment; radiographic evaluation of RemeOs screw biodegradation; complication rates (loss of fixation, infection, non-union, revision surgery); pain intensity (Visual Analog Scale); and PROMIS Physical Function and Pain Interference.
Statistical analysis: Longitudinal OMAS changes will be analyzed using a linear mixed-effects model with time as a fixed effect and subject as a random effect. Secondary outcomes will be summarized descriptively; continuous variables compared with paired t-tests or Mann-Whitney U tests as appropriate; time to revision evaluated by Kaplan-Meier analysis where applicable. A p-value < 0.05 is considered significant.
All clinical procedures (surgery, imaging, follow-up) are standard care delivered regardless of study participation; the only research-specific procedures are informed consent and completion of patient-reported outcome measures.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Mani Eftekhari, BS
- Telefonní číslo: 15108506056
- E-mail: meftekhari@mgh.harvard.edu
Studijní místa
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02114
- Massachusetts General Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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 Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Olerud-Molander Ankle Score (OMAS)
Časové okno: 12 months
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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.
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12 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Radiographic Fracture Healing and Alignment
Časové okno: 6 weeks, 3 months, 6 months, and 12 months postoperatively
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Radiographic assessment of fracture union and maintenance of anatomic alignment of the ankle mortise on serial postoperative radiographs.
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6 weeks, 3 months, 6 months, and 12 months postoperatively
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Radiographic RemeOs Screw Biodegradation
Časové okno: 3 months, 6 months, and 12 months postoperatively
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Radiographic evaluation of the biodegradation behavior of the RemeOs magnesium-based screws over time, including gas formation and implant resorption.
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3 months, 6 months, and 12 months postoperatively
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Complication Rate
Časové okno: 12 months
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Proportion of participants experiencing complications, including loss of fixation, infection, non-union, and revision surgery.
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12 months
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Pain Intensity
Časové okno: Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively
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Pain intensity measured on a Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain); lower scores indicate less pain.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively
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PROMIS
Časové okno: Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively
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ROMIS Physical Function and PROMIS Pain Interference.
Both are reported as Patient-Reported Outcomes Measurement Information System (PROMIS) T-scores standardized to the US general population (mean 50, SD 10, minimum 0, maximum 100).
For Physical Function, higher scores indicate a better outcome.
For Pain Interference, higher scores indicate a worse outcome.
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Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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