Surgical Plate Osteosynthesis of Distal Radius Fractures

Phase 4

Terminated

• Conditions: Distal Radius Fractures

• Registration Number: NCT00205998
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

Brief Summary

Primary objective of the study is to demonstrate specific indications for the

surgical treatment of distal radius fractures using the locking compression

plate.

Detailed Description

In addition the differences between the surgical treatment compared to

conservative treatment with respect to fracture healing, functional outcome

and subject satisfaction will be analysed after 6w./6m./1y./2y.

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2005-12
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-26
• Last Update Posted: 2007-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• skeletally mature female and male
• Distal radius and ulnar fractures AO 23
• 10 days after injury

Exclusion Criteria

• general or local conditions adversely affecting the bone physiology
• ISS >16
• osteosynthesis close to the wrist joint where a different implant has been used
• history of drug and alcohol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
- Document specific indications for the surgical treatment of distal radius fractures using the LCP

Secondary Outcome Measures

Name	Time	Method
- Primary reduction and maintenance of reduction of the plate fixation
- Functional outcome scoring using "Garetland and Werley, DASH and SF-36 scoring
- Patient and surgeon satisfaction
- Analysis of the occured complications

Trial Locations

Locations (3)

Harvard Medical School; 🇺🇸 Boston, Massachusetts, United States

York District Hospital; 🇬🇧 York, United Kingdom

BG-Unfallklinik Ludwigshafen; 🇩🇪 Ludwigshafen, Germany