Birmingham Hip Resurfacing (BHR) Study: Implantation of a Hip Resurfacing Endoprosthesis

This study is currently recruiting participants.

Verified by Dresden University of Technology, September 2005

Sponsored by:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00180206

Purpose

The purpose of this study is the investigation of the functional and radiological results and subjective patient outcome after the implantation of a hip resurfacing endoprosthesis (Birmingham hip resurfacing).

Condition	Intervention	Phase
Arthritis	Device: Birmingham Hip Resurfacing	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Prospective, Non-Randomised, Non-Comparative Multicentric Investigation of the Functional and Radiological Result and Subjective Patient Outcome After Implantation of a Hip Resurfacing Endoprosthesis (Birmingham Hip Resurfacing)

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

Functional result
Radiological result
Subjective patient outcome

Secondary Outcome Measures:

Perioperative and postoperative complication rate
Revision rate

Estimated Enrollment:	300
Study Start Date:	January 2005
Estimated Study Completion Date:	December 2008

Detailed Description:

High volumetric wear of polyethylene was the main factor in periprosthetic bone resorption and failure of historic hip resurfacing prosthesis. Metal-on-metal devices reduce the wear substantially and may solve this problem. The purpose of this study is the investigation of the functional and radiological result and subjective patient outcome after implantation of a hip resurfacing endoprosthesis (Birmingham Hip Resurfacing) during the first two years after surgery.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical and radiological signs of coxarthritis
Implantation of a total hip replacement indicated
Informed consent

Exclusion Criteria:

Osteoporosis
Tumor
Acute infection
Higher grade congenital dysplasia of the hip
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180206

Contacts

Contact: Wolf-Christoph Witzleb, MD

+49 (0)351 4583323

Wolf-Christoph.Witzleb@uniklinikum-dresden.de

Locations

Germany
Department of Orthopaedic Surgery, University Hospital, Technical University of Dresden	Recruiting
Dresden, Germany, 01307
Contact: Wolf-Christoph Witzleb, MD +49 (0)351 4583323 Wolf-Christoph.Witzleb@uniklinikum-dresden.de
Sub-Investigator: Wolf-Christop Witzleb, MD

Sponsors and Collaborators

Dresden University of Technology

Investigators

Principal Investigator:

Klaus-Peter Guenther, Prof.

Department of Orthopaedic Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden

More Information

Study ID Numbers:	DresdenU
Study First Received:	September 13, 2005
Last Updated:	January 13, 2006
ClinicalTrials.gov Identifier:	NCT00180206
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

Arthritis
Hip
Hip arthroplasty
Hip resurfacing arthroplasty

Study placed in the following topic categories:

Musculoskeletal Diseases
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on January 16, 2009