metaCARpal Bone Osteosynthesis Trail
ConditionMetacarpal Shaft Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Access to a valid e-mail.
Injury within 10 days prior to inclusion.
Normal bilateral hand function prior to injury.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Non-operative treatment with early mobilization
Procedure/SurgeryParticipants 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.
Operative treatment
Procedure/SurgeryParticipants 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.
Treatment groups
552 Participants
are divided into 2 treatment groupsGroup A: Non-operative with early mobilizationExperimental treatment 1 intervention
Group B: OperativeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Grip strength
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 monthsSecondary outcomes
1
Complications
infection, malunion, nerve injury, reoperation
Time frame
From enrollment to the end of follow-up at 12 months2
Pain in injured hand NRS
NRS (Numerical Rating Scale) at rest and when it is at its worst
Time frame
From enrollment to the end of follow-up at 12 months3
Rotational deformity
0 - no deformity, 1 - minimal deformity, 2 - clearly visible deformity but acceptable functional limitation, 3 - great deformity and functional limitation
Time frame
12 months4
PROM - patient rated outcome measure
Quick-DASH-9 score (Gabel et al., 2009)
Time frame
6, 12 weeks, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Uppsala University
Collaborator
Umeå University
Collaborator
University of Oslo
Collaborator
Tampere University
Collaborator
Københavns Universitet
Collaborator
Göteborg University
Collaborator
Linkoeping University
Collaborator
Region Stockholm
Collaborator
Östersunds Hospital
Collaborator
Source ClinicalTrials.gov