Overview

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

Summary

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

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Clavicle plate on the superior surface of the bone
superior plate
Open reduction internal fixation (ORIF) clavicle with superior plate
(Experimental)
plate placed on anterior inferior surface of bone
anterior-inferior plate
ORIF clavicle with anterior inferior plate

Primary Outcomes

Measure
Less irritation with anterior-inferior plating and less need for hardware removal.
time frame: 2 years

Secondary Outcomes

Measure
DASH (Disability of Arm, Shoulder and Hand) and constant scores
time frame: 2 years

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by United States Army Institute of Surgical Research.