- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05869331
Midterm (Min. 3yr) Follow-up of Patients With Single Spiral/Oblique Finger Metacarpal Fracture
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Falun, Sweden, 791 82
- Falun Regional Hospital
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Uppsala, Sweden, 75135
- Uppsala University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Nonoperative treatment
Patients in this group were treated with early mobilization.
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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.
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Active Comparator: Operative treatment
Patients in this group were treated surgically.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grip strength
Time Frame: 3-6 years
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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.
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3-6 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DASH score
Time Frame: 3-6 years
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Disability of Arm, Shoulder and Hand questionnaire score, a patient-reported outcome measure.
Scored 1-100, 1 representing best possible value.
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3-6 years
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Metacarpal shortening
Time Frame: 3-6 years
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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.
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3-6 years
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Rotation
Time Frame: 3-6 years
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Presence of any rotation deformity on clinical examination
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3-6 years
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Subjective pain
Time Frame: 3-6 years
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Pain graded by patient using a numeric rating scale (NRS) 1-10, 1 representing best possible value
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3-6 years
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Subjective cosmetic result
Time Frame: 3-6 years
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Cosmetic result graded by patient using a numeric rating scale (NRS) 1-10, 1 representing best possible value
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3-6 years
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Subjective overall result
Time Frame: 3-6 years
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Overall result of treatment outcome graded by patient using a numeric rating scale (NRS) 1-10, 1 representing best possible value
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3-6 years
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Time off work
Time Frame: 3-6 years
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The time off work measured in days, or time until return to normal function (in retired patients or patients attending education)
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3-6 years
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Range of motion
Time Frame: 3-6 years
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Range of motion of the affected finger ray presented as total active motion (TAM)
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3-6 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Björn Äng, Professor, Region Dalarna
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 276742
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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