Plating Clavicle Fractures
Does Anterior-Inferior Clavicle Plating Have a Lower Rate of Soft Tissue Irritation Compared to Superior Plating? A Prospective Randomized Trial
1 other identifier
interventional
90
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2008
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 26, 2009
CompletedFirst Posted
Study publicly available on registry
March 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedOctober 13, 2017
December 1, 2016
9.8 years
March 26, 2009
October 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Less irritation with anterior-inferior plating and less need for hardware removal.
2 years
Secondary Outcomes (1)
DASH (Disability of Arm, Shoulder and Hand) and constant scores
2 years
Study Arms (2)
superior plate
ACTIVE COMPARATORClavicle plate on the superior surface of the bone
anterior inferior plate
EXPERIMENTALplate placed on anterior inferior surface of bone
Interventions
Open reduction internal fixation (ORIF) clavicle with superior plate
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
William Beaumont Army Medical Center
El Paso, Texas, 79920-5001, United States
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2009
First Posted
March 30, 2009
Study Start
October 1, 2008
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
October 13, 2017
Record last verified: 2016-12