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

Study 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).

Official Title
-----------------
Conservative Treatment Versus Plate Osteosynthesis Using Angular Stabile Screws and Precontoured Plates in Displaced Midshaft Clavicular Fractures. A Prospective Randomized Multicenter Study

Conditions
-----------------
Displaced Midshaft Fracture of the Collar Bone

Intervention / Treatment
-----------------
* Procedure: Operation using a precontoured titanium plate and screws
* Procedure: Displaced midshaft fracture of the collar bone


Participation Criteria
=================
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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm sling treatment<br>Displaced midshaft fracture of the collar bone treated with an arm sling | Procedure: Displaced midshaft fracture of the collar bone<br>* Displaced midshaft fracture of the collar bone treated with an arm sling<br>* Other names: No other names.;|
| Experimental: Operation<br>Displaced midshaft fracture of the collar bone treated with operation using a pre contoured titanium plate and screws. | Procedure: Operation using a precontoured titanium plate and screws<br>* Operation using a precontoured titanium plate and screws<br>* Other names: No other names.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant-Murley Score |  | 6 weeks, 3 months, 6 months, 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fracture, Collar bone