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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Technische Universität Dresden.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00180206
First received: September 13, 2005
Last updated: January 13, 2006
Last verified: September 2005
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Further study details as provided by Technische Universität Dresden:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by Technische Universität Dresden:
Arthritis
Hip
Hip arthroplasty
Hip resurfacing arthroplasty

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 14, 2014