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metaCARpal Bone Osteosynthesis Trail

RecruitingNAAges 18 Years - anyAllKarolinska Institutet
NCT07357493 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background Metacarpal shaft fractures account for 30-50% of hand fractures (Karl et al., 2015; Kollitz et al., 2014; van Onselen et al., 2003), with diaphyseal spiral and oblique fractures of the second to fifth ray posing unique challenges due to the risks of shortening and rotational deformities. Current standard care of displaced fractures involves operative fixation. However, retrospective studies have indicated that nonoperative treatment, involving early mobilization or buddy taping, can achieve outcomes comparable to operative treatment (Daher et al., 2023). There is only one published, with a small sample size, randomized controlled trial (RCT) investigating this issue (Peyronson et al., 2023). This highlights the need for a robust multicenter RCT to address these gaps in evidence. Aim The aim of this study is to compare the one-year outcomes of non-operative treatment involvin

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years. * Access to a valid e-mail. * Injury within 10 days prior to inclusion. * Normal bilateral hand function prior to injury. * Ability and willingness to provide written informed consent * Single, displaced spiral or oblique diaphyseal fracture of the second to fifth metacarpals with definition of diaphysis as described by AO 2018 (AO/OTA as 77.2-5.2A) (Meinberg et al., 2018). * Fracture line length at least twice the diameter of the bone at the level of the fracture. * Fractures with at least 2 mm of radiological displacement and/or malrotation of injured finger compared to uninjured side regardless of fracture displacement. Exclusion Criteria: * The patient IS NOT expected to have difficulty adhering to the study protocol (e.g., due to insufficient language proficiency, dementia, substance abuse, or other reasons). * The patient DOES NOT have an open fracture (Gustilo-Anderson grade \> I) or a pathological fracture. * The patient DOES NOT have an ipsilateral fracture of the upper extremity, polytrauma, or generalized joint dysfunction (e.g., rheumatoid arthritis).
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What it tests

  • Non-operative treatment with early mobilization
  • Operative treatment
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Where

1 site
Karolinska Institutet, Danderyd's hospital
Stockholm, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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