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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00180206 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Birmingham Hip Resurfacing (BHR) Study: Implantation of a Hip Resurfacing Endoprosthesis
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Scientific title:
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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) |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00180206 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Germany
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Contacts
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Name:
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Wolf-Christoph Witzleb, MD |
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Address:
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Telephone:
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+49 (0)351 4583323 |
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Email:
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Wolf-Christoph.Witzleb@uniklinikum-dresden.de |
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Affiliation:
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Name:
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Wolf-Christoph Witzleb, MD |
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Address:
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Telephone:
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+49 (0)351 4583323 |
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Email:
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Wolf-Christoph.Witzleb@uniklinikum-dresden.de |
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Affiliation:
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Name:
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Klaus-Peter Guenther, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Orthopaedic Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Arthritis
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Intervention(s)
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Device: Birmingham Hip Resurfacing
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Primary Outcome(s)
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Functional result
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Subjective patient outcome
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Radiological result
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Secondary Outcome(s)
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Revision rate
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Perioperative and postoperative complication rate
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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