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

Not Applicable

Completed

• Conditions: Displaced Midshaft Fracture of the Collar Bone
• Interventions: Procedure: Displaced midshaft fracture of the collar bone; Procedure: Operation using a precontoured titanium plate and screws

• Registration Number: NCT01078480
• Lead Sponsor: Northern Orthopaedic Division, Denmark

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-27
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Study Start: 2010-04
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-21
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm sling treatment	Displaced midshaft fracture of the collar bone	Displaced midshaft fracture of the collar bone treated with an arm sling
Operation	Operation using a precontoured titanium plate and screws	Displaced midshaft fracture of the collar bone treated with operation using a pre contoured titanium plate and screws.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Constant-Murley Score	6 weeks, 3 months, 6 months, 1 year

Trial Locations

Locations (1)

Orthopaedic Division, Randers Hospital; 🇩🇰 Randers, Central Jutland, Denmark