Displaced Midshaft Fracture of the Collar Bone Clinical Trial
Official title:
Conservative Treatment Versus Plate Osteosynthesis Using Angular Stabile Screws and Precontoured Plates in Displaced Midshaft Clavicular Fractures. A Prospective Randomized Multicenter Study
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).
| Status | Completed |
| Enrollment | 140 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 - circumstances which make follow-up impossible, i.e. address far from the including departments and stays abroad of long duration - medical contraindication against surgery or general anaesthesia - former participation in the trial - former fracture contra/ipsilateral at the age of 15 or older |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Orthopaedic Division, Randers Hospital | Randers | Central Jutland |
| Lead Sponsor | Collaborator |
|---|---|
| Northern Orthopaedic Division, Denmark | Central Jutland Regional Hospital, Randers Regional Hospital, Swemac Orthopaedics ApS, Vejle Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disabilities of the Arm, Shoulder and Hand (DASH) Score | 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. | 6 weeks, 3 months, 6 months, 1 year | No |
| Secondary | Constant-Murley Score | 6 weeks, 3 months, 6 months, 1 year | No |