Metacarpal shaft fractures: operative fixation versus immediate unrestricted mobilization
Official title: The CARBO Study (metaCARpal Bone Osteosynthesis)
Run by Karolinska Institutet · NCT07357493 · Data updated 2026-11-12
It tests whether immediate unrestricted mobilization (no surgery) provides similar one-year outcomes to operative fixation for adults with displaced spiral or oblique metacarpal shaft fractures.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 552 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm, Stockholm County) |
| Status | Recruiting |
| Started | March 23, 2026 |
| Main results expected | March 15, 2030 |
| Study ends | March 15, 2031 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT07357493 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with a single displaced spiral or oblique diaphyseal fracture of the second–fifth metacarpals within 10 days of injury, who had normal bilateral hand function before the injury and can give informed consent and access email.
✕Probably not a fit
Patients with open Gustilo–Anderson grade > I or pathological fractures, multiple or complex hand injuries, or those unable to adhere to follow-up or protocol requirements are unlikely to benefit from the nonoperative approach tested here.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter randomized comparison enrolling adults with a single displaced spiral or oblique diaphyseal fracture of the second to fifth metacarpals to either non-operative treatment with immediate unrestricted mobilization or standard operative fixation. Participants are enrolled within 10 days of injury and followed for one year to compare recovery, complications, and need for additional procedures. The trial is led by Karolinska Institutet with collaborating sites at Uppsala University, Umeå University and the University of Oslo. The aim is to provide higher-quality multicenter randomized evidence to clarify whether non-operative management can match surgical outcomes.
Why it matters
Potential benefit: If successful, many patients could avoid surgery and recover with early mobilization while achieving similar function and potentially fewer surgery-related risks.
How similar studies have gone: Retrospective studies and one small randomized trial have reported comparable outcomes for nonoperative early mobilization versus surgery, but robust multicenter randomized evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
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Karolinska Institutet, Danderyd's hospital
Stockholm, Stockholm County, Sweden Recruiting
Study contacts
- Study coordinator: Cecilia Mellstrand Navarro, Associate professor
- Email: cecilia.mellstrand.navarro@ki.se
- Phone: +46709280114
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.