Conservative or Operative Treatment of Fractures in the Neck of the 5th Metacarpal Bone
Not Applicable
Completed
- Conditions
- Fractures of the Neck
- Interventions
- Procedure: Bouquet pinning of the 5th metacarpal bone
- Registration Number
- NCT01139528
- Lead Sponsor
- Oslo University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Operative treatment Bouquet pinning of the 5th metacarpal bone 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
- Primary Outcome Measures
Name Time Method Quick-DASH 6 weeks, 3 months, 1 year, 2 years Validated hand function score
- Secondary Outcome Measures
Name Time Method Grip strength 3 months, 1 year, 2 years Compared to the non-injured hand
Complications 1 week, 6 weeks, 3 months, 1 year, 2 years All complications are noted
Patient satisfaction 6 weeks, 3 months, 1 year, 2 years VAS scale
Eq-5d 6 weeks, 3 months, 1 year, 2 years Validated quality of life score
Range of motion in the joints in the 5th finger measured by hand therapist 3 months, 1 year, 2 years total active motion 5th finger, totale passive motion 5th finger, active and passive extension and flexion in the 5th MCP-joint
Pain 1 week, 6 weeks, 3 months, 1 year, 2 years VAS scale
Sick-leave 1 week, 6 weeks, 3 months (1 year, 2 years) Days of sick-leave off work
Angular displacement in fracture measured in lateral x-ray, and shortening in fracture measured in AP view, of the 5th ray of the hand 6 weeks, 1 year
Trial Locations
- Locations (1)
Oslo University Hospital
🇳🇴Oslo, Norway