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

Primary Purpose

Metacarpal Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Early mobilization
Operative treatment
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metacarpal Fracture focused on measuring Metacarpal fracture, Spiral fracture, Early mobilization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Falun Regional Hospital
  • Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nonoperative treatment

Operative treatment

Arm Description

Patients in this group were treated with early mobilization.

Patients in this group were treated surgically.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 11, 2023
Last Updated
May 26, 2023
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT05869331
Brief Title
Midterm (Min. 3yr) Follow-up of Patients With Single Spiral/Oblique Finger Metacarpal Fracture
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metacarpal Fracture
Keywords
Metacarpal fracture, Spiral fracture, Early mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nonoperative treatment
Arm Type
Experimental
Arm Description
Patients in this group were treated with early mobilization.
Arm Title
Operative treatment
Arm Type
Active Comparator
Arm Description
Patients in this group were treated surgically.
Intervention Type
Procedure
Intervention Name(s)
Early mobilization
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Operative treatment
Intervention Description
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 Outcome Measure Information:
Title
Grip strength
Description
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.
Time Frame
3-6 years
Secondary Outcome Measure Information:
Title
DASH score
Description
Disability of Arm, Shoulder and Hand questionnaire score, a patient-reported outcome measure. Scored 1-100, 1 representing best possible value.
Time Frame
3-6 years
Title
Metacarpal shortening
Description
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.
Time Frame
3-6 years
Title
Rotation
Description
Presence of any rotation deformity on clinical examination
Time Frame
3-6 years
Title
Subjective pain
Description
Pain graded by patient using a numeric rating scale (NRS) 1-10, 1 representing best possible value
Time Frame
3-6 years
Title
Subjective cosmetic result
Description
Cosmetic result graded by patient using a numeric rating scale (NRS) 1-10, 1 representing best possible value
Time Frame
3-6 years
Title
Subjective overall result
Description
Overall result of treatment outcome graded by patient using a numeric rating scale (NRS) 1-10, 1 representing best possible value
Time Frame
3-6 years
Title
Time off work
Description
The time off work measured in days, or time until return to normal function (in retired patients or patients attending education)
Time Frame
3-6 years
Title
Range of motion
Description
Range of motion of the affected finger ray presented as total active motion (TAM)
Time Frame
3-6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fredrik Peyronson, Md
Phone
018-6110000
Email
Fredrik.Peyronson@surgsci.uu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilia Stalberg Ostwald, Md
Email
cecilia.stalbergostwald@surgsci.uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Björn Äng, Professor
Organizational Affiliation
Region Dalarna
Official's Role
Study Chair
Facility Information:
Facility Name
Falun Regional Hospital
City
Falun
ZIP/Postal Code
791 82
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilia Stalberg Ostwald, Md
Email
cecilia.stalbergostwald@surgsci.uu.se
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
75135
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fredrik Peyronson, Md
Phone
0703051340
Email
Fredrik.Peyronson@surgsci.uu.se

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36455163
Citation
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.
Results Reference
background

Learn more about this trial

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

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