Magnesium-Based Screws for Syndesmotic Fixation in Unstable Ankle Fractures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Olerud-Molander Ankle Score (OMAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: RemeOs Magnesium-Based Biodegradable Screw (Device)
结局指标
主要结局
Olerud-Molander Ankle Score (OMAS)
时间窗: 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.
次要结局
- 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)
研究者
Soheil Ashkani Esfahani
Director of Foot & Ankle Research and Innovation Lab (FARIL)
Massachusetts General Hospital