Conservative Treatment Versus Plate Osteosynthesis Using Angular Stabile Screws and Precontoured Plates in Displaced Midshaft Clavicular Fractures. A Prospective Randomized Multicenter Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Displaced Midshaft Fracture of the Collar Bone
- Sponsor
- Northern Orthopaedic Division, Denmark
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Disabilities of the Arm, Shoulder and Hand (DASH) Score
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study will compare non-operative treatment of displaced midshaft collarbone fractures with operative treatment using a precontoured titanium plate and screws.
The study hypothesis is that operation will provide better pain relief, faster return to activities, better function of the involved upper limb, and lower the risk of a non healing fracture (non union).
Investigators
Eligibility Criteria
Inclusion Criteria
- •fracture located to the mid third of the collar bone where there is no contact between the fractured surface of the main fragments on x-ray in one or two of two levels.
Exclusion Criteria
- •bilateral fracture
- •imminent skin perforation
- •open fracture
- •associated neurovascular effect
- •unstable fracture of neck of scapula "floating shoulder"
- •fracture of coincidental upper extremity distal for the shoulder
- •pathologic fracture
- •the patient states that there was a unilateral or bilateral shoulder problem before the fracture
- •fracture realized more than 14 days after it arose
- •circumstances which make it impossible to carry out one of the two regimes, i.e. mental illness and abuse
Outcomes
Primary Outcomes
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame: 6 weeks, 3 months, 6 months, 1 year
The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. The tool gives clinicians and researchers the advantage of having a single, reliable instrument that can be used to assess any or all joints in the upper extremity.
Secondary Outcomes
- Constant-Murley Score(6 weeks, 3 months, 6 months, 1 year)