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

Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00180206
• Other study ID #: DresdenU
• Status: Recruiting
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: January 13, 2006
• Start date: January 2005
• Est. completion date: December 2008

Study information

• Verified date: September 2005
• Source: Technische Universität Dresden
• Contact: Wolf-Christoph Witzleb, MD
• Phone: +49 (0)351 4583323
• Email: Wolf-Christoph.Witzleb[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis

Intervention

Device:
• Birmingham Hip Resurfacing

Locations

Country	Name	City	State
Germany	Department of Orthopaedic Surgery, University Hospital, Technical University of Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional result
Primary	Radiological result
Primary	Subjective patient outcome
Secondary	Perioperative and postoperative complication rate
Secondary	Revision rate