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

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ClinicalTrials.gov Identifier: NCT00180206
Recruitment Status : Unknown
Verified September 2005 by Technische Universität Dresden.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : January 16, 2006
Sponsor:
Information provided by:
Technische Universität Dresden

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 Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
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 : January 2005
Study Completion Date : December 2008



Primary Outcome Measures :
  1. Functional result
  2. Radiological result
  3. Subjective patient outcome

Secondary Outcome Measures :
  1. Perioperative and postoperative complication rate
  2. Revision rate


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00180206     History of Changes
Other Study ID Numbers: DresdenU
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: January 16, 2006
Last Verified: September 2005

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

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases