Conservative Treatment Compared to Osteosynthesis in Patients With a Fractured Collar Bone

Northern Orthopaedic Division, Denmark

Status

Completed

Conditions

Displaced Midshaft Fracture of the Collar Bone

Treatments

Procedure: Displaced midshaft fracture of the collar bone

Procedure: Operation using a precontoured titanium plate and screws

Study type

Interventional

Funder types

Other

Identifiers

NCT01078480

ON-001-CMJ

Details and patient eligibility

About

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).

Enrollment

140 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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