Surgical Plate Osteosynthesis of Distal Radius Fractures - Full Text View

Purpose

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

surgical treatment of distal radius fractures using the locking compression

plate.

Condition	Intervention	Phase
Distal Radius Fractures	Device: Locking Compression Plate 2,4mm Device: Locking Compression Plate 3,5mm	Phase IV

MedlinePlus related topics:

Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

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

Further study details as provided by AO Clinical Investigation and Documentation:

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

Enrollment:	450
Study Start Date:	December 2001
Study Completion Date:	December 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205998

Locations


United States, Massachusetts
	Harvard Medical School
	Boston, Massachusetts, United States, 02114

Germany
	BG-Unfallklinik Ludwigshafen
	Ludwigshafen, Germany, 67071

United Kingdom
	York District Hospital
	York, United Kingdom, YO31 8HE

Sponsors and Collaborators

AO Clinical Investigation and 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 University

Principal Investigator:	Peter G De Boer, F.R.C.S.	York District Hospital

More Information

Study ID Numbers:	01-LCP2,4/3,5-03
First Received:	September 13, 2005
Last Updated:	April 26, 2007
ClinicalTrials.gov Identifier:	NCT00205998
Health Authority:	Switzerland: Swissmedic; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AO Clinical Investigation and Documentation:

Locking Compression Plate

Conservative treatment

Surgical treatment

Radius fractures

AO 23

Study placed in the following topic categories:

Fractures, Bone

Wounds and Injuries

Forearm Injuries

Disorders of Environmental Origin

Radius Fractures

Arm Injuries

ClinicalTrials.gov processed this record on October 16, 2008

Sponsors and Collaborators:	AO Clinical Investigation and Documentation Synthes Inc. AO Hand Expert Group
Information provided by:	AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:	NCT00205998