metaCARpal Bone Osteosynthesis Trail

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

Interventions

PROCEDURE

Non-operative treatment with early mobilization

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

Operative treatment

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.

Sponsors & Collaborators

• Uppsala University

  collaborator OTHER

• Umeå University

  collaborator OTHER

• University of Oslo

  collaborator OTHER

• Tampere University

  collaborator OTHER

• Københavns Universitet

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• Linkoeping University

  collaborator OTHER_GOV

• Region Stockholm

  collaborator OTHER_GOV

• Östersund Hospital

  collaborator UNKNOWN

• Karolinska Institutet

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-23

Primary Completion

2030-03-15

Completion

2031-03-15

Countries

• Sweden

Study Locations