Conservative or Operative Treatment of Fractures in the Neck of the 5th Metacarpal Bone (MC-studien)
This study is currently recruiting participants.
Verified April 2011 by Oslo University Hospital
Sponsor:
Oslo University Hospital
Collaborators:
University Hospital, Akershus
Asker & Baerum Hospital
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01139528
First received: May 18, 2010
Last updated: April 18, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fractures of the Neck |
Procedure: Bouquet pinning of the 5th metacarpal bone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Conservative Treatment Versus Operative Treatment of Extra-articular Fractures in the Neck of the 5th Metacarpal Bone- A Prospective Randomized Trial |
Resource links provided by NLM:
Further study details as provided by Oslo University Hospital:
Primary Outcome Measures:
- Quick-DASH [ Time Frame: 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]Validated hand function score
Secondary Outcome Measures:
- Patient satisfaction [ Time Frame: 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]VAS scale
- Pain [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]VAS scale
- Eq-5d [ Time Frame: 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]Validated quality of life score
- Complications [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]All complications are noted
- Sick-leave [ Time Frame: 1 week, 6 weeks, 3 months (1 year, 2 years) ] [ Designated as safety issue: No ]Days of sick-leave off work
- Range of motion in the joints in the 5th finger measured by hand therapist [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]total active motion 5th finger, totale passive motion 5th finger, active and passive extension and flexion in the 5th MCP-joint
- Grip strength [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]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 [ Time Frame: 6 weeks, 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Operative treatment
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
|
Procedure: Bouquet pinning of the 5th metacarpal bone
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
|
|
No Intervention: Conservative treatment
No attempt of reduction of the fracture, 7-10 days of cast treatment followed by 5 weeks of buddy-strapping
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139528
Contacts
| Contact: Ida Neergård Sletten, MD | +4702770 | ida.sletten@live.no |
| Contact: Hebe Desiree Kvernmo, MD, PhD | +4702770 | hebe.kvernmo@gmail.com |
Locations
| Norway | |
| Oslo University Hospital | Recruiting |
| Oslo, Norway, NO-0407 | |
| Contact: Ida Neergård Sletten, Cand.med. | |
Sponsors and Collaborators
Oslo University Hospital
University Hospital, Akershus
Asker & Baerum Hospital
Investigators
| Study Chair: | Lars Nordsletten, Prof. MD, PhD | University of Oslo, Norway |
More Information
No publications provided
| Responsible Party: | Ida Neergård Sletten, MD, Oslo University Hospital-Ullevaal |
| ClinicalTrials.gov Identifier: | NCT01139528 History of Changes |
| Other Study ID Numbers: | FASUUS 1529 |
| Study First Received: | May 18, 2010 |
| Last Updated: | April 18, 2011 |
| Health Authority: | Norway: Ethics Committee |
Keywords provided by Oslo University Hospital:
|
Fracture 5th metacarpal bone Bouquet pinning Fractures of the neck of the 5th metacarpal bone |
Additional relevant MeSH terms:
|
Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013