Surgical Plate Osteosynthesis of Distal Radius Fractures

Sponsor

AO Clinical Investigation and Publishing Documentation (Other)

Overall Status

Terminated

CT.gov ID

NCT00205998

Collaborator

Synthes Inc. (Industry), AO Hand Expert Group (Other)

450

Enrollment

Locations

Duration (Months)

150

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fractures	Device: Locking Compression Plate 2,4mm Device: Locking Compression Plate 3,5mm	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

450 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2001

Actual Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

- Document specific indications for the surgical treatment of distal radius fractures using the LCP []

Secondary Outcome Measures

- 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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harvard Medical School	Boston	Massachusetts	United States	02114
2	BG-Unfallklinik Ludwigshafen	Ludwigshafen		Germany	67071
3	York District Hospital	York		United Kingdom	YO31 8HE

Sponsors and Collaborators

AO Clinical Investigation and Publishing Documentation
Synthes Inc.
AO Hand Expert Group

Investigators

Principal Investigator: Andreas W Wentzensen, Prof. MD, BG-Unfallklinik Ludwigshafen
Principal Investigator: Jesse B Jupiter, Prof. MD, Harvard Medical School (HMS and HSDM)
Principal Investigator: Peter G De Boer, F.R.C.S., York District Hospital