Displaced Midshaft Fracture of the Collar Bone
Conditions
Keywords
Fracture, Collar bone
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).
Interventions
PROCEDUREOperation using a precontoured titanium plate and screws
Operation using a precontoured titanium plate and screws
PROCEDUREDisplaced midshaft fracture of the collar bone
Displaced midshaft fracture of the collar bone treated with an arm sling
Sponsors
Central Jutland Regional Hospital
Vejle Hospital
Randers Regional Hospital
Swemac Orthopaedics ApS
Northern Orthopaedic Division, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of the Arm, Shoulder and Hand (DASH) Score | 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
| Measure | Time frame |
|---|---|
| Constant-Murley Score | 6 weeks, 3 months, 6 months, 1 year |
Countries
Denmark
Outcome results
None listed