Plating Clavicle Fractures

Study Overview
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Brief Summary
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The anterior-inferior clavicle plate position will have a lower rate of soft tissue irritation that limits activity and/or requires hardware removal compared to superior plate position.

Detailed Description
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Compare the rates of soft-tissue irritation with two different methods of plating for clavicle fractures. Patients will be randomized to anterior-inferior or superior plating. Validated shoulder scoring systems will be used to assess outcome. Specific follow-up questions will address the patient's ability to wear his/her uniform, body armor, ruck sack, and other shoulder-borne equipment over the surgical site.

Official Title
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Does Anterior-Inferior Clavicle Plating Have a Lower Rate of Soft Tissue Irritation Compared to Superior Plating? A Prospective Randomized Trial

Conditions
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Clavicle Fracture, Non Union/Malunion

Intervention / Treatment
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* Procedure: superior plate
* Procedure: anterior-inferior plate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active duty, Reservists, National Guard service members completely displaced shaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments) a fracture involving the middle third of the clavicle (a fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment) chronic nonunion and malunion fractures no medical contraindications to general anesthesia provided informed consent. Exclusion Criteria: an age of less than eighteen years or greater than sixty five years a fracture in the proximal or distal third of the clavicle not amenable to plating a pathological fracture an associated head injury (a Glasgow Coma Scale score of <15 at 21 days after injury) an inability to comply with followup a medical contraindication to surgery and/or anesthesia (such as heart disease, renal failure, or active chemotherapy) a lack of consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: superior plate<br>Clavicle plate on the superior surface of the bone | Procedure: superior plate<br>* Open reduction internal fixation (ORIF) clavicle with superior plate<br>|
| Experimental: anterior inferior plate<br>plate placed on anterior inferior surface of bone | Procedure: anterior-inferior plate<br>* ORIF clavicle with anterior inferior plate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Less irritation with anterior-inferior plating and less need for hardware removal. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DASH (Disability of Arm, Shoulder and Hand) and constant scores |  | 2 years |