Metaphyseal Distal Radius Fractures

Not Applicable

Completed

• Conditions: Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2)

• Registration Number: NCT01156766
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Detailed Description

Because an increasing number of elderly patient, 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 exist of which in particular locking plates and intrafocal pinning.

The availability of new materials (locking plates with angular stability) seems to reduce the risks of osteosynthesis failure and seems to give more constant results: hawever, the price to pay is a more invasive technique and a superior cost. The rehabilitation seems also faster, allowing the possibility to get back the maximum of autonomy.

These clinical facts need of course to be validated.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-02
• Study First Posted: 2010-07-05
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• • metaphyseal inferior radius fractures (AO classification 23A2, 23A3, 23C1, 23C2)
• age 60 years or older

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
- 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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France