Midterm (Min. 3yr) Follow-up of Patients With Single Spiral/Oblique Finger Metacarpal Fracture

Uppsala University

Status: Completed

Conditions: Metacarpal Fracture

Treatments: Procedure: Operative treatment; Procedure: Early mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT05869331

276742

Details and patient eligibility

About

Spiral metacarpal fractures (metacarpal II-V) can be treated conservatively or with operation. With minimal displacement this fracture is usually treated with immobilisation or early mobilisation. With appreciable displacement especially any malrotation the patient usually is treated with an operation. This usually includes an open reduction of the fracture and fixation with plates and screws or just screws.

The hypothesis that nonoperative treatment (using early mobilization without splintage) will result in similar outcomes to operative treatment was previously tested by this research group (Peyronson et al. JBJS American 2023). Over a 1-year follow-up the primary outcome of grip strength was found to be noninferior.

This trial will extend the follow-up period and re-evaluate the patients included in the original cohort to identify any difference over a 3-6 year follow up.

Full description

The original trial was a noninferiority randomized controlled trial evaluating 42 patients. Randomization was performed 1:1 to either nonoperative treatment with mobilization initiated immediately following recruitment or operative treatment using ORIF with cortical screws or locking compression plate (LCP) and screw fixation.

The non-inferiority margin (NIM) was defined as -15% grip strength of the injured hand relative to the contralateral hand. The same NIM will be used for this trial.

Because subtle biomechanical changes (mainly metacarpal bone shortening) could theoretically cause problems not evident at 1-year follow-up (such as joint degeneration from changes in load distribution), the investigators plan to re-evaluate the patients for a longer-term follow-up.

Only patients included in the original trial will be eligible for inclusion in this extended follow-up. Participation will be offered via mail invitation, and participants will be offered financial compensation in the form of a single payment of 500SEK.

Data collection will be performed in a single outpatient hospital visit where patient history, subjective outcome data and bilateral plain radiography of the hands will be obtained.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Previous inclusion in the original study population, i.e.:

• Diaphyseal, single spiral, and oblique fractures of the index to little finger metacarpals
• Fracture line length at least twice the diameter of the bone at the level of the fracture
• At least 2-mm displacement and/or shortening of the fracture or malrotation
• Normal hand function before the injury
• Fracture <10 days old

Exclusion criteria

• Multiple metacarpal fractures
• Open fractures
• Inability to follow instructions
• Fracture line length less than twice the diameter of the bone at the level of the fracture
• Abnormal hand function before the injury
• Previous ipsilateral hand fractures
• Fracture ≥10 days old at possible randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Nonoperative treatment

Experimental group

Description:

Patients in this group were treated with early mobilization.

Treatment:

Procedure: Early mobilization

Operative treatment

Active Comparator group

Description:

Patients in this group were treated surgically.

Treatment:

Procedure: Operative treatment