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

Sponsor

Technische Universität Dresden (Other)

Overall Status

Unknown status

CT.gov ID

NCT00180206

Collaborator

(none)

300

Enrollment

Location

Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Arthritis	Device: Birmingham Hip Resurfacing	Phase 4

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Study Start Date :

Jan 1, 2005

Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

Functional result []
Radiological result []
Subjective patient outcome []

Secondary Outcome Measures

Perioperative and postoperative complication rate []
Revision rate []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Orthopaedic Surgery, University Hospital, Technical University of Dresden	Dresden		Germany	01307

Sponsors and Collaborators

Technische Universität Dresden

Investigators

Principal Investigator: Klaus-Peter Guenther, Prof., Department of Orthopaedic Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden