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

Not Applicable

Completed

• Conditions: Metacarpal Fracture

• Registration Number: NCT05869331
• Lead Sponsor: Uppsala University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-11
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-22
• Study Start: 2023-05-29
• Primary Completion: 2024-02-05
• Study Completion: 2024-02-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Grip strength	3-6 years	Grip strength is measured in both hands using a JAMAR dynamometer set to 2nd position with the patient sitting down, arm resting in 90 degree elbow flexion and neutral forearm rotation. Three measurements are taken in each arm and the mean value calculated. The strength of the injured hand is expressed as a percentage value relative to the strength of the contralateral (uninjured) hand.

Secondary Outcome Measures

Name	Time	Method
DASH score	3-6 years	Disability of Arm, Shoulder and Hand questionnaire score, a patient-reported outcome measure. Scored 1-100, 1 representing best possible value.
Metacarpal shortening	3-6 years	Shortening of the metacarpal bone measured on plain radiographs comparing the length of the injured bone to the contralateral corresponding bone and calculating the difference in millimeters.
Rotation	3-6 years	Presence of any rotation deformity on clinical examination
Subjective pain	3-6 years	Pain graded by patient using a numeric rating scale (NRS) 1-10, 1 representing best possible value
Subjective cosmetic result	3-6 years	Cosmetic result graded by patient using a numeric rating scale (NRS) 1-10, 1 representing best possible value
Subjective overall result	3-6 years	Overall result of treatment outcome graded by patient using a numeric rating scale (NRS) 1-10, 1 representing best possible value
Time off work	3-6 years	The time off work measured in days, or time until return to normal function (in retired patients or patients attending education)
Range of motion	3-6 years	Range of motion of the affected finger ray presented as total active motion (TAM)

Trial Locations

Locations (2)

Falun Regional Hospital; 🇸🇪 Falun, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden