Back to resultsBirmingham Hip Resurfacing (BHR) Study: Implantation of a Hip Resurfacing Endoprosthesis
Primary Purpose
Arthritis
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Birmingham Hip Resurfacing
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis focused on measuring Arthritis, Hip, Hip arthroplasty, Hip resurfacing arthroplasty
Eligibility 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
Sites / Locations
- Department of Orthopaedic Surgery, University Hospital, Technical University of DresdenRecruiting
Outcomes
Primary Outcome Measures
Functional result
Radiological result
Subjective patient outcome
Secondary Outcome Measures
Perioperative and postoperative complication rate
Revision rate
Full Information
NCT ID
NCT00180206
First Posted
September 13, 2005
Last Updated
January 13, 2006
Sponsor
Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT00180206
Brief Title
Birmingham Hip Resurfacing (BHR) Study: Implantation of a Hip Resurfacing Endoprosthesis
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 Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Technische Universität Dresden
4. Oversight
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
Arthritis, Hip, Hip arthroplasty, Hip resurfacing arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Birmingham Hip Resurfacing
Primary Outcome Measure Information:
Title
Functional result
Title
Radiological result
Title
Subjective patient outcome
Secondary Outcome Measure Information:
Title
Perioperative and postoperative complication rate
Title
Revision rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wolf-Christoph Witzleb, MD
Phone
+49 (0)351 4583323
Email
Wolf-Christoph.Witzleb@uniklinikum-dresden.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus-Peter Guenther, Prof.
Organizational Affiliation
Department of Orthopaedic Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedic Surgery, University Hospital, Technical University of Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolf-Christoph Witzleb, MD
Phone
+49 (0)351 4583323
Email
Wolf-Christoph.Witzleb@uniklinikum-dresden.de
First Name & Middle Initial & Last Name & Degree
Wolf-Christop Witzleb, MD
12. IPD Sharing Statement
Learn more about this trial
Birmingham Hip Resurfacing (BHR) Study: Implantation of a Hip Resurfacing Endoprosthesis
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