Skip to main content
OpenTrials
Completed

NCT Number: NCT05869331

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metacarpal Fracture Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Falun Regional Hospital, Falun, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Grip strength

    Time frame: 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 outcomes

  1. DASH score

    Time frame: 3-6 years

    Disability of Arm, Shoulder and Hand questionnaire score, a patient-reported outcome measure. Scored 1-100, 1 representing best possible value.

  2. Metacarpal shortening

    Time frame: 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.

  3. Rotation

    Time frame: 3-6 years

    Presence of any rotation deformity on clinical examination

  4. Subjective pain

    Time frame: 3-6 years

    Pain graded by patient using a numeric rating scale (NRS) 1-10, 1 representing best possible value

  5. Subjective cosmetic result

    Time frame: 3-6 years

    Cosmetic result graded by patient using a numeric rating scale (NRS) 1-10, 1 representing best possible value

  6. Subjective overall result

    Time frame: 3-6 years

    Overall result of treatment outcome graded by patient using a numeric rating scale (NRS) 1-10, 1 representing best possible value

  7. Time off work

    Time frame: 3-6 years

    The time off work measured in days, or time until return to normal function (in retired patients or patients attending education)

  8. Range of motion

    Time frame: 3-6 years

    Range of motion of the affected finger ray presented as total active motion (TAM)

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

Midterm (Min. 3yr) Follow-up of Patients With Single Spiral/Oblique Finger Metacarpal Fracture Following Early Mobilization Nonoperative Treatment or Operative Treatment With Screw Fixation - a Noninferiority Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 22, 2023
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.