Metaphyseal Distal Radius Fractures
Locking Plate Versus Pins for Surgical Treatment of Posteriorly Tilted Distal Radius Fracture
1 other identifier
interventional
90
1 country
1
Brief Summary
The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques. The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.
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 Jun 2010
Typical duration for not_applicable
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
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 2, 2010
CompletedFirst Posted
Study publicly available on registry
July 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJune 12, 2013
June 1, 2013
2.8 years
July 2, 2010
June 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
- X-ray assessments (preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths)
preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths
Secondary Outcomes (3)
PAIN score (2 weeks, 5 weeks, 3, 6 and 12 months)
2 weeks, 5 weeks, 3, 6 and 12 months
Gartland, O'Brien, DASH and Euroquol EQ-5D scores (5 weeks, 3, 6 and 12 months)
5 weeks, 3, 6 and 12 months
Grip and pinch strength (5 weeks, 3, 6 and 12 months)
5 weeks, 3, 6 and 12 months
Interventions
The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques. The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.
Eligibility Criteria
You may qualify if:
- \- metaphyseal inferior radius fractures (AO classification 23A2, 23A3, 23C1, 23C2)
- age 60 years or older
You may not qualify if:
- open fracture
- fractures AO classification: 23A1, 23C3, 23B1, 23B2, 23B3
- polytraumatized patient
- fractures older than 15 days
- infection of the operating site
- previous osseous disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Clermont-Ferrandlead
- Stryker SAcollaborator
- Polyclinique du Parc Rambotcollaborator
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stéphane DESCAMPS, MD
University Hospital, Clermont-Ferrand
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
July 2, 2010
First Posted
July 5, 2010
Study Start
June 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
June 12, 2013
Record last verified: 2013-06