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

NCT05869331 | Completed

• 1 other identifier: 276742
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Metacarpal Fracture

Keywords

Metacarpal fracture; Spiral fracture; Early mobilization

Outcome Measures

Primary Outcomes (1)

• Grip strength

  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.

  3-6 years

Secondary Outcomes (8)

• DASH score

  3-6 years

• Metacarpal shortening

  3-6 years

• Rotation

  3-6 years

• Subjective pain

  3-6 years

• Subjective cosmetic result

  3-6 years

Study Arms (2)

Nonoperative treatment

EXPERIMENTAL

Patients in this group were treated with early mobilization.

Procedure: Early mobilization

Operative treatment

ACTIVE COMPARATOR

Patients in this group were treated surgically.

Procedure: Operative treatment

Interventions

Early mobilization PROCEDURE

Patients randomized to nonoperative treatment have already received treatment using early mobilization in the original trial, and all fractures have been confirmed healed. Mobilization consisted of 5 repetitions of full finger extension followed by maximum finger flexion, and 5 such sets of 5 were required per day for the first 6 weeks. Buddy taping or resting splint was offered if the patient experienced difficulty, and mobilization was performed by all patients in this treatment arm.

Nonoperative treatment

Operative treatment PROCEDURE

Patients randomized to operative treatment have already received treatment using open reduction and internal fixation (ORIF) with cortical screws in the original trial, and all fractures have been confirmed healed. Surgery was performed under general anaesthesia through a dorsal incision centered over the fractured metacarpal. Reduction was performed under visual inspection and fixation performed using 2 or more cortical screws (Synthes Compact Hand 2.0) as first option. At the surgeons preference fixation using plate and screw fixation was also allowed. Postoperatively patients were put in a plaster cast for two weeks and then hand therapy was initiated.

Operative treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (2)

Falun Regional Hospital

Falun, 791 82, Sweden

Location

Uppsala University Hospital

Uppsala, 75135, Sweden

Location

Related Publications (1)

• Peyronson F, Ostwald CS, Hailer NP, Giddins G, Vedung T, Muder D. Nonoperative Versus Operative Treatment for Displaced Finger Metacarpal Shaft Fractures: A Prospective, Noninferiority, Randomized Controlled Trial. J Bone Joint Surg Am. 2023 Jan 18;105(2):98-106. doi: 10.2106/JBJS.22.00573. Epub 2022 Nov 10.

  PMID: 36455163 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

• Björn Äng, Professor

  Region Dalarna

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: May 29, 2023
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)