[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07693933":3,"trial-entities:NCT07693933":108,"trial-summary:NCT07693933":112},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":15,"eligibility_criteria":65,"std_ages":87,"locations":90,"central_contacts":99,"overall_officials":105,"references":106,"see_also_links":107},"NCT07693933","2026P000142","Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery","Magnesium-Based Screws for Syndesmotic Fixation in Unstable Ankle Fractures","NOT_YET_RECRUITING","2029-03","2026-07","2026-07-27","2026-08","Massachusetts General Hospital","OTHER",false,"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.\n\nThis 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.\n\nThe 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.\n\nAfter 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.\n\nThe 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.\n\nThe 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.","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.\n\nDesign: 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.\n\nIntervention: All participants will undergo open reduction and internal fixation (ORIF) of their ankle fracture using RemeOs magnesium-based biodegradable screws for fracture fixation and\u002For 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.\n\nAssessments: 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.\n\nPrimary outcome: Functional recovery measured by the Olerud-Molander Ankle Score (OMAS) at 12 months.\n\nSecondary 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.\n\nStatistical 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 \\\u003C 0.05 is considered significant.\n\nAll 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.",[19,20],"Ankle Fractures","Syndesmotic Injury",[22,23],"Magnesium-based screw","Biodegradable implant","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},28,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","RemeOs Magnesium-Based Biodegradable Screw","ORIF performed using RemeOs magnesium-alloy biodegradable screws (Screw LAG, Screw COM, Screw FT, and\u002For Screw LAG Solid) for fixation of any malleolus and\u002For 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.",[37],"RemeOs Magnesium Screw Fixation",[39],{"measure":40,"description":41,"timeFrame":42},"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",[44,48,52,55,59],{"measure":45,"description":46,"timeFrame":47},"Radiographic Fracture Healing and Alignment","Radiographic assessment of fracture union and maintenance of anatomic alignment of the ankle mortise on serial postoperative radiographs.","6 weeks, 3 months, 6 months, and 12 months postoperatively",{"measure":49,"description":50,"timeFrame":51},"Radiographic RemeOs Screw Biodegradation","Radiographic evaluation of the biodegradation behavior of the RemeOs magnesium-based screws over time, including gas formation and implant resorption.","3 months, 6 months, and 12 months postoperatively",{"measure":53,"description":54,"timeFrame":42},"Complication Rate","Proportion of participants experiencing complications, including loss of fixation, infection, non-union, and revision surgery.",{"measure":56,"description":57,"timeFrame":58},"Pain Intensity","Pain intensity measured on a Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain); lower scores indicate less pain.","Baseline, 6 weeks, 3 months, 6 months, and 12 months postoperatively",{"measure":60,"description":61,"timeFrame":58},"PROMIS","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.","ALL","18 Years","80 Years",{"inclusion":66,"exclusion":72,"raw_text":86},[67,68,69,70,71],"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)",[73,74,75,76,77,78,79,80,81,82,83,84,85],"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","Inclusion Criteria:\n\n* Age 18-80 years\n* Unstable closed ankle fracture requiring surgical fixation, including unimalleolar, bimalleolar, bimalleolar-equivalent, or trimalleolar fractures\n* Fractures may be with or without syndesmotic instability\n* Willingness to follow postoperative visits and rehabilitation protocols\n* Ability to complete patient-reported outcome measures (PROMs)\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\> 40\n* Open fractures\n* Pathologic fractures\n* Active infection at the surgical site\n* Known allergy or hypersensitivity to magnesium or implant components\n* Severe peripheral vascular disease\n* Uncontrolled diabetes mellitus\n* Prior ankle surgery on the affected limb\n* Concomitant osteochondral lesions requiring treatment\n* Neuromuscular disorders affecting the lower extremity\n* Worker's compensation cases\n* Pregnancy\n* Non-adherence concerns or inability to comply with follow-up requirements",[88,89],"ADULT","OLDER_ADULT",[91],{"facility":13,"city":92,"state":93,"zip":94,"country":95,"geoPoint":96},"Boston","Massachusetts","02114","United States",{"lat":97,"lon":98},42.35843,-71.05977,[100],{"name":101,"role":102,"phone":103,"email":104},"Mani Eftekhari, BS","CONTACT","15108506056","meftekhari@mgh.harvard.edu",[],[],[],{"nct_id":4,"conditions":109,"biomarkers":111},[110],"Ankle Fracture",[],{"nct_id":4,"found":113,"summary":114,"prompt_version":123},true,{"design":115,"status":116,"heading":6,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This is a single-arm study, meaning all participants will receive the RemeOs magnesium-based screws. It plans to enroll 28 participants.","completed","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.","Your ankle recovery will be measured at 12 months after surgery.",114,"You would need to follow postoperative visits and rehabilitation protocols, and be able to complete patient-reported outcome measures.","Not stated in the trial record.",[],"v2"]