metaCARpal Bone Osteosynthesis Trail

NCT07357493 | Recruiting

• 2 other identifiers: 2025-04413-01FoUI-1022484
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metacarpal Shaft Fractures

Keywords

Non-operative; operative; metacarpal; shaft; displaced; mobilization

Outcome Measures

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).

  From enrollment to the end of follow-up at 12 months

Secondary Outcomes (12)

• Complications

  From enrollment to the end of follow-up at 12 months

• Pain in injured hand NRS

  From enrollment to the end of follow-up at 12 months

• Rotational deformity

  12 months

• PROM - patient rated outcome measure

  6, 12 weeks, 12 months

• Range of motion

  6, 12 weeks, 12 months

Study Arms (2)

Non-operative with early mobilization

EXPERIMENTAL

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.

Procedure: Non-operative treatment with early mobilization

Operative

ACTIVE COMPARATOR

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.

Procedure: Operative treatment

Interventions

Non-operative treatment with early mobilization PROCEDURE

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.

Non-operative with early mobilization

Operative treatment PROCEDURE

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.

Operative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Access to a valid e-mail.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Karolinska Institutet: lead
• 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
• Östersund Hospital: collaborator

Study Sites (1)

Karolinska Institutet, Danderyd's hospital

Stockholm, Stockholm County, 18288, Sweden

RECRUITING

MeSH Terms

Interventions

Early Ambulation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Central Study Contacts

Cecilia Mellstrand Navarro, Associate professor

CONTACT

+46709280114; cecilia.mellstrand.navarro@ki.se

Elsa Pihl, PhD

CONTACT

+46739705669; elsa.pihl@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 22, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): March 15, 2030
• Study Completion (Estimated): March 15, 2031
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)