Surgical Plate Osteosynthesis of Distal Radius Fractures

Distal Radius Fractures Clinical Trial

Official title:

Surgical Plate Osteosynthesis of Distal Radius Fractures. Prospective Study of the Locking Compression Plate (LCP)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00205998
• Other study ID #: 01-LCP2,4/3,5-03
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: April 26, 2007
• Start date: December 2001
• Est. completion date: December 2005

Study information

• Verified date: April 2007
• Source: AO Clinical Investigation and Documentation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

surgical treatment of distal radius fractures using the locking compression

plate.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 450
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures

Intervention

Device:
• Locking Compression Plate 2,4mm

• Locking Compression Plate 3,5mm

Locations

Country	Name	City	State
Germany	BG-Unfallklinik Ludwigshafen	Ludwigshafen
United Kingdom	York District Hospital	York
United States	Harvard Medical School	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
AO Clinical Investigation and Documentation	AO Hand Expert Group, Synthes Inc.

Countries where clinical trial is conducted

United States,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Document specific indications for the surgical treatment of distal radius fractures using the LCP
Secondary	- Primary reduction and maintenance of reduction of the plate fixation
Secondary	- Functional outcome scoring using "Garetland and Werley, DASH and SF-36 scoring
Secondary	- Patient and surgeon satisfaction
Secondary	- Analysis of the occured complications