Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures

Study Overview
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Brief Summary
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Clavicle (collar bone) fractures account for about 33% of all fractures around the shoulder. Some surgeons suggest that surgical treatment is the best option, while others suggest that nonoperative care is the best treatment. There is no evidence to date that either option in superior. For this reason, we propose to conduct a prospective, randomized clinical trial of surgical versus non-surgical treatment of displaced high-energy clavicle fractures. This study will use both objective clinical and patient-based outcome measures. The purpose of this study is to see if there is a difference between clinical outcomes (healing rate, time to healing, time to return to work, Constant Score, complications), functional outcomes (DASH Score), and health related quality of life (SF-36) in nonoperative care and two types of surgical care for displaced fractures of the clavicular shaft in adults. Included patients will be randomized into one of three groups: nonoperative care (Group N); surgical care using plates and screws (Group P); and surgical care using intramedullary pin put inside of the clavicle to stabilize it (Group I).

Official Title
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A Multicenter, Prospective, Randomized Trial of Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures

Conditions
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High Energy Midshaft Clavicle Fractures

Intervention / Treatment
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* Procedure: ORIF with Plate and Screws
* Procedure: Pin Fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages of 18 and 85 a midshaft clavicle fracture fracture displaced the width of the clavicle or shortened at least 1.5 cm less than 21 days since the injury Exclusion Criteria: injury involving the lateral ligaments fracture involve the sternoclavicular joint Pathologic Fracture Open Fracture Fracture with neurovascular compromise Displaced fracture with impending skin compromise Medical comorbidities that preclude surgery Associated injuries to ipsilateral shoulder girdle severe cognitive disability or injury that may inhibit study form completion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Closed<br>Closed Treatment | |
| Active Comparator: ORIF<br>Open Reduction and Internal Fixation (ORIF) with Plate and Screws | Procedure: ORIF with Plate and Screws<br>* ORIF with plate and screws<br>|
| Active Comparator: Pin<br>Pin Fixation | Procedure: Pin Fixation<br>* Clavicle fixation with clavicle pin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability of Arm, Shoulder and Hand (DASH) scores | Disability of Arm, Shoulder and Hand (DASH) scores | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation rate | rate of reoperations between groups | 1 year |