NCT Number: NCT07357493
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 involving immediate unrestricted mobilization versus operative treatment of displaced oblique or spiral diaphyseal metacarpal fractures in adults.
Materials and Methods This is a multicenter, pragmatic, prospective, noninferiority RCT involving 552 adult patients with displaced oblique and/or spiral diaphyseal metacarpal fractures of the second to fifth ray. Participants will be randomized 1:1 to receive either nonoperative treatment with unrestricted mobilization and rehabilitation) or operative treatment (with screw or plate fixation) followed by rehabilitation.
The primary outcome is grip-strength in the injured hand presented in kilograms at one year.
Secondary outcomes include questionnaires, complications, range of motion, patient reported outcome measures, health related quality of life, patient satisfaction, and radiographic healing.
A power calculation proposes a study size of 552 participants to detect a noninferiority margin of 10% in grip strength.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Stockholm, Stockholm County, 18288, Sweden
Location status: Recruiting
Cecilia Mellstrand Navarro, MD, Ass Professor
CONTACT
Cecilia Mellstrand Navarro, MD, PhD
PRINCIPAL_INVESTIGATOR
Elsa Pihl, MD, PhD
CONTACT
Elsa Pihl, MD, PhD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants randomized to the nonoperative group will receive immediate unrestricted mobilization, with optional buddy taping or removable splinting for comfort. Closed reduction will not be attempted. Rehabilitation protocol with early mobilization will be standardized across study centers with printed standardized information to patients and rehabilitation staff.
Participants randomized to the operative group will undergo open reduction and internal fixation (ORIF) of the MSF. Peri-operative antibiotic prophylaxis will be administered according to local guidelines. The surgical approach and fixation method (e.g. compression screws and/or plate, not K-wires) will be at the discretion of the treating surgeon, following standard surgical principles. Postoperative immobilisation will adhere to surgeons' preference but not exceed two weeks fixation.
Time frame: From enrollment to the end of follow-up at 12 months
The primary outcome is grip-strength measured in the injured hand using a JAMAR dynamometer at 12 months and presented in kilograms. Measurement method will follow the technical description presented in the HAKIR manual (HAKIR, 2023).
Time frame: From enrollment to the end of follow-up at 12 months
infection, malunion, nerve injury, reoperation
Time frame: From enrollment to the end of follow-up at 12 months
NRS (Numerical Rating Scale) at rest and when it is at its worst
Time frame: 12 months
0 - no deformity, 1 - minimal deformity, 2 - clearly visible deformity but acceptable functional limitation, 3 - great deformity and functional limitation
Time frame: 6, 12 weeks, 12 months
Quick-DASH-9 score (Gabel et al., 2009)
Time frame: 6, 12 weeks, 12 months
total active motion and extension lag
Time frame: 12 weeks, 12 months
Time frame: 12 months
according to Sletten (Sletten et al., 2013)
Time frame: 12 weeks, 12 months
defined as bridging callus formation over the fracture line on a plain x-ray anterio-posterior and/or lateral projection. (Hayes et al., 2023)
Time frame: 12 months
in days
Time frame: From enrollment to the end of follow-up at 12 months
Patient Acceptable Symptom State, PASS (Daryoush et al., 2025)
Time frame: From enrollment to the end of follow-up at 12 months
EQ-5D EuroQol Group, 1990; Taft et al., 2004)
Time frame: From enrollment to the end of follow-up at 12 months
SF-12 (EuroQol Group, 1990; Taft et al., 2004)
Contact information is provided by the study sponsor or research team.
Cecilia Mellstrand Navarro, Associate professor
CONTACT
Elsa Pihl, PhD
CONTACT
Karolinska Institutet
Other
The CARBO Study (metaCARpal Bone Osteosynthesis)
Acronym: CARBO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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