Fractures of the Neck Clinical Trial
— MC-studienOfficial title:
Conservative Treatment Versus Operative Treatment of Extra-articular Fractures in the Neck of the 5th Metacarpal Bone- A Prospective Randomized Trial
Verified date | April 2015 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Norway: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 85 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Asker & Baerum Hospital, University Hospital, Akershus |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quick-DASH | Validated hand function score | 6 weeks, 3 months, 1 year, 2 years | No |
Secondary | Patient satisfaction | VAS scale | 6 weeks, 3 months, 1 year, 2 years | No |
Secondary | Pain | VAS scale | 1 week, 6 weeks, 3 months, 1 year, 2 years | No |
Secondary | Eq-5d | Validated quality of life score | 6 weeks, 3 months, 1 year, 2 years | No |
Secondary | Complications | All complications are noted | 1 week, 6 weeks, 3 months, 1 year, 2 years | No |
Secondary | Sick-leave | Days of sick-leave off work | 1 week, 6 weeks, 3 months (1 year, 2 years) | No |
Secondary | 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 | 3 months, 1 year, 2 years | No |
Secondary | Grip strength | Compared to the non-injured hand | 3 months, 1 year, 2 years | No |
Secondary | 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 | No |