Study Stopped
PI left institution
Study Comparing Intramedullary Nailing, Plate Fixation, and Non-operative Treatment of Clavicle Fractures
Comparison of Intramedullary Nailing, Plate Fixation, and Non-operative Treatment of Acute, Displaced, Midshaft Clavicle Fractures: a Prospective Randomized Trial
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Patients with acute, displaced fractures of the middle third of the clavicle will be randomly assigned into either the non-operative treatment group or the operative treatment group. The operative treatment group will be randomly assigned to repair with either an intramedullary device or a plate and screws.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2009
1 active site
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
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
March 9, 2011
CompletedSeptember 30, 2016
September 1, 2016
Same day
March 1, 2011
September 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Disability of the Arm, Shoulder, and Hand (DASH)
2, 6, and 12 weeks and 6 and 12 months
Secondary Outcomes (1)
The Constant Pain Score
2, 6, and 12 weeks and 6 and 12 months
Study Arms (3)
No surgery
ACTIVE COMPARATORNon-operative Treatment
Plate fixation
ACTIVE COMPARATOROperative Treatment-Plate fixation
Intramedullary pinning
ACTIVE COMPARATOROperative Treatment-Intramedullary Pinning
Interventions
A figure-of-8 brace will be applied to afflicted extremity in clinic. The patient will be instructed on proper application of the brace and asked to continue wearing the brace for 2 to 6 weeks, depending on the patient's level of comfort.
Plate fixation of the clavicle fracture will be performed utilizing a 3.5-mm dynamic compression plate.
Clavicle fracture will be repaired through intramedullary pinning using The Rockwood Clavicle Pin (DePuy Orthopaedics, Warsaw, IN).
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Missouri-Columbia
Columbia, Missouri, 65212, United States
Related Publications (2)
Bostman O, Manninen M, Pihlajamaki H. Complications of plate fixation in fresh displaced midclavicular fractures. J Trauma. 1997 Nov;43(5):778-83. doi: 10.1097/00005373-199711000-00008.
PMID: 9390489BACKGROUNDCanadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am. 2007 Jan;89(1):1-10. doi: 10.2106/JBJS.F.00020.
PMID: 17200303BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Richard A White, M.D.
University of Missouri-Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2011
First Posted
March 9, 2011
Study Start
May 1, 2009
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
September 30, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share