Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures

Study Overview
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Brief Summary
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The purpose of this study is to find whether to operate or treat conservatively dislocated midshaft clavicle fractures.

Detailed Description
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Midshaft clavicle fractures are common comprising 2% of all fractures and 35% to 45% of all shoulder girdle injuries in adults. Old-established treatment practices, based on no randomised controlled trials, are used for clavicle fractures. By tradition, midshaft clavicle fractures have been treated conservatively with arm immobilized to a sling for few weeks. The goal of treatment is to restore painless function of the upper extremity. There have been some recommendations for operative treatment, such as skin compromising in fracture area, open fracture, floating shoulder, neurovascular symptoms in upper extremity, or multiple injuries. Recently, increasing interest has emerged in the surgical treatment.

Official Title
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Nonoperative Versus Operative Treatment of Midshaft Clavicle Fractures - A Randomized Controlled Trial

Conditions
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Clavicle, Fracture

Intervention / Treatment
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* Procedure: Operative treatment
* Procedure: Non-operative treatment with arm immobilised to a sling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a completely displaced middle third clavicle fracture, no cortical contact between main fragments fresh fracture, treatment within seven days after injury age between 18 and 70 years provided informed consent Exclusion Criteria: fracture was not dislocated multiple injured patient associated neurovascular injury, or suspicion of it reduced cooperation cancer or any severe illness impairing health pathological fracture treatment seven days after injury open fracture corticosteroid or immunosuppressive medication upper extremity fracture at same time an earlier clavicle or shoulder region fracture pregnancy lack of consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-operative treatment<br>Non-operative (conservative) treatment of the clavicle fracture | Procedure: Non-operative treatment with arm immobilised to a sling<br>* Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately.<br>|
| Active Comparator: Operative treatment<br>Operative stabilization (i.e. ORIF) of the fracture with a plate and screws. | Procedure: Operative treatment<br>* Fracture stabilization with stainless steel reconstruction plate and screws. After the operation arm is immobilized to a sling for three weeks. Pendulum movements are allowed immediately.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder function | Shoulder Function is measured by Constant shoulder Score (CS) is a outcome measure for assessing the outcomes of the treatment of shoulder disorders.It inclues the pain score, functional assessment, range of motion and strength measures. | Three months | 
| Shoulder function | Shoulder Function is measured by Constant shoulder Score (CS) is a outcome measure for assessing the outcomes of the treatment of shoulder disorders.It inclues the pain score, functional assessment, range of motion and strength measures. | One year | 
| Shoulder function | Shoulder Function is measured by Constant shoulder Score (CS) is a outcome measure for assessing the outcomes of the treatment of shoulder disorders.It inclues the pain score, functional assessment, range of motion and strength measures. | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability of the Arm, Shoulder and Hand (DASH) | The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. | Three months | 
| Pain at rest and activity | Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly. | Three weeks | 
| Fracture healing | Fracture healing is examined from Xray. | Three months | 
| Complications | Number of participants who are confronted complications such as nonunion, malunion, infection, hardware breakdown or hardware irritation. | Continous till two years | 
| Disability of the Arm, Shoulder and Hand (DASH) | The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. | One year | 
| Disabilities of the Arm, Shoulder and Hand (DASH) | The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. | Two years | 
| Pain at rest and activity | Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly. | Six weeks | 
| Pain at rest and at activity | Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly | Three months | 
| Pain at rest and at activity | Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly | One year | 
| Pain at rest and at activity | Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly | Two years | 
| Fracture healing | Fracture healing is examined from Xray. | One year | 
| Fracture healing | Fracture healing is examined from Xray. | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clavicle fractures, midshaft, dislocated, operative treatment, conservative treatment, non-operative treatment, randomized controlled trial, bone plates