Back to resultsConservative or Operative Treatment of Fractures in the Neck of the 5th Metacarpal Bone (MC-studien)
Primary Purpose
Fractures of the Neck
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Bouquet pinning of the 5th metacarpal bone
Sponsored by
About this trial
This is an interventional treatment trial for Fractures of the Neck focused on measuring Fracture, 5th metacarpal bone, Bouquet pinning, Fractures of the neck of the 5th metacarpal bone
Eligibility Criteria
Inclusion Criteria:
- Patients over 18 years of age with fractures of the neck of the 5th metacarpal bone
Exclusion Criteria:
- Less than 30 degrees of volar angulation in the fracture
- rotational deformity
- pseudoclawing
- intra-articular involvement
- ad latus displacement more than one half of a bone width
- concomitant fractures or soft tissue damage
- admittance more than 14 days after injury
- non-compliant patient (language, drugs, tourist)
- patient who refuses to participate in the study
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Operative treatment
Conservative treatment
Arm Description
Closed reduction of the fracture and osteosynthesis with 2-3 intramedullary K-wires (Bouquet method), cast treatment for 7-10 days followed by 5 weeks of buddy-strapping before removal of the K-pins
No attempt of reduction of the fracture, 7-10 days of cast treatment followed by 5 weeks of buddy-strapping
Outcomes
Primary Outcome Measures
Quick-DASH
Validated hand function score
Secondary Outcome Measures
Patient satisfaction
VAS scale
Pain
VAS scale
Eq-5d
Validated quality of life score
Complications
All complications are noted
Sick-leave
Days of sick-leave off work
Range of motion in the joints in the 5th finger measured by hand therapist
total active motion 5th finger, totale passive motion 5th finger, active and passive extension and flexion in the 5th MCP-joint
Grip strength
Compared to the non-injured hand
Angular displacement in fracture measured in lateral x-ray, and shortening in fracture measured in AP view, of the 5th ray of the hand
Full Information
NCT ID
NCT01139528
First Posted
May 18, 2010
Last Updated
April 23, 2015
Sponsor
Oslo University Hospital
Collaborators
University Hospital, Akershus, Asker & Baerum Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01139528
Brief Title
Conservative or Operative Treatment of Fractures in the Neck of the 5th Metacarpal Bone
Acronym
MC-studien
Official Title
Conservative Treatment Versus Operative Treatment of Extra-articular Fractures in the Neck of the 5th Metacarpal Bone- A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
University Hospital, Akershus, Asker & Baerum Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A multi-site randomized controlled trial where patients are allocated to operative treatment or conservative treatment of fractures of the neck of the 5th metacarpal bone. The study goal is to identify which degree of angular displacement in the fracture that requires operative intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures of the Neck
Keywords
Fracture, 5th metacarpal bone, Bouquet pinning, Fractures of the neck of the 5th metacarpal bone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Operative treatment
Arm Type
Active Comparator
Arm Description
Closed reduction of the fracture and osteosynthesis with 2-3 intramedullary K-wires (Bouquet method), cast treatment for 7-10 days followed by 5 weeks of buddy-strapping before removal of the K-pins
Arm Title
Conservative treatment
Arm Type
No Intervention
Arm Description
No attempt of reduction of the fracture, 7-10 days of cast treatment followed by 5 weeks of buddy-strapping
Intervention Type
Procedure
Intervention Name(s)
Bouquet pinning of the 5th metacarpal bone
Intervention Description
The fracture is reduced under general anesthesia and 2-3 K-pins are introduced in the medullar cavity to keep the fracture in the reduced position
Primary Outcome Measure Information:
Title
Quick-DASH
Description
Validated hand function score
Time Frame
6 weeks, 3 months, 1 year, 2 years
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
VAS scale
Time Frame
6 weeks, 3 months, 1 year, 2 years
Title
Pain
Description
VAS scale
Time Frame
1 week, 6 weeks, 3 months, 1 year, 2 years
Title
Eq-5d
Description
Validated quality of life score
Time Frame
6 weeks, 3 months, 1 year, 2 years
Title
Complications
Description
All complications are noted
Time Frame
1 week, 6 weeks, 3 months, 1 year, 2 years
Title
Sick-leave
Description
Days of sick-leave off work
Time Frame
1 week, 6 weeks, 3 months (1 year, 2 years)
Title
Range of motion in the joints in the 5th finger measured by hand therapist
Description
total active motion 5th finger, totale passive motion 5th finger, active and passive extension and flexion in the 5th MCP-joint
Time Frame
3 months, 1 year, 2 years
Title
Grip strength
Description
Compared to the non-injured hand
Time Frame
3 months, 1 year, 2 years
Title
Angular displacement in fracture measured in lateral x-ray, and shortening in fracture measured in AP view, of the 5th ray of the hand
Time Frame
6 weeks, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over 18 years of age with fractures of the neck of the 5th metacarpal bone
Exclusion Criteria:
Less than 30 degrees of volar angulation in the fracture
rotational deformity
pseudoclawing
intra-articular involvement
ad latus displacement more than one half of a bone width
concomitant fractures or soft tissue damage
admittance more than 14 days after injury
non-compliant patient (language, drugs, tourist)
patient who refuses to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Nordsletten, Prof. MD, PhD
Organizational Affiliation
University of Oslo
Official's Role
Study Chair
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
NO-0407
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
23060463
Citation
Sletten IN, Nordsletten L, Hjorthaug GA, Hellund JC, Holme I, Kvernmo HD. Assessment of volar angulation and shortening in 5th metacarpal neck fractures: an inter- and intra-observer validity and reliability study. J Hand Surg Eur Vol. 2013 Jul;38(6):658-66. doi: 10.1177/1753193412461582. Epub 2012 Oct 11.
Results Reference
derived
Learn more about this trial
Conservative or Operative Treatment of Fractures in the Neck of the 5th Metacarpal Bone
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