Plating Clavicle Fractures
This trial is active, not recruiting.
|Condition||clavicle fracture, non union/malunion|
|Treatments||superior plate, anterior-inferior plate|
|Sponsor||United States Army Institute of Surgical Research|
|Collaborator||William Beaumont Army Medical Center|
|Start date||October 2008|
|End date||August 2016|
|Trial size||90 participants|
|Trial identifier||NCT00871468, H-08-003|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
Less irritation with anterior-inferior plating and less need for hardware removal.
time frame: 2 years
DASH (Disability of Arm, Shoulder and Hand) and constant scores
time frame: 2 years
Male or female participants from 18 years up to 65 years old.
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.
|Official title||Does Anterior-Inferior Clavicle Plating Have a Lower Rate of Soft Tissue Irritation Compared to Superior Plating? A Prospective Randomized Trial|
|Description||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.|
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