ArthritisPhase 4NCT00180206
Birmingham Hip Resurfacing (BHR) Study: Implantation of a Hip Resurfacing Endoprosthesis
A Phase 4 study testing Birmingham Hip Resurfacing in people with Arthritis, run by Technische Universität Dresden at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arthritis
- What is being tested?
- Birmingham Hip Resurfacing
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2005to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and radiological signs of coxarthritis
- Implantation of a total hip replacement indicated
- Informed consent
Who cannot join
- Osteoporosis
- Tumor
- Acute infection
- Higher grade congenital dysplasia of the hip
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Orthopaedic Surgery, University Hospital, Technical University of Dresden
Dresden, 01307
Wolf-Christoph Witzleb, MD, +49 (0)351 4583323, Wolf-Christoph.Witzleb@uniklinikum-dresden.de
Wolf-Christop Witzleb, MD
About this study
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)
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).
Read the 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.
- Conditions
- Arthritis
- Being tested
- Birmingham Hip Resurfacing
- Keywords
- Arthritis, Hip, Hip arthroplasty, Hip resurfacing arthroplasty
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Birmingham Hip ResurfacingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional result
Radiological result
Subjective patient outcome
Secondary outcomes (2)
Perioperative and postoperative complication rate
Revision rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2005
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Klaus-Peter Guenther, Prof., Principal investigator, Department of Orthopaedic Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180206
- Sponsor's protocol ID
- DresdenU
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 16 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00180206
- Acronym / sponsor ID
- DresdenU
- Conditions
- Arthritis
- Keywords
- Arthritis, Hip, Hip arthroplasty, Hip resurfacing arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Dec 2008
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical and radiological signs of coxarthritis
- Implantation of a total hip replacement indicated
- Informed consent
Key exclusion criteria (5 listed)
- Osteoporosis
- Tumor
- Acute infection
- Higher grade congenital dysplasia of the hip
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Birmingham Hip Resurfacing | Device | – |
Primary outcome
Functional result
Radiological result
Subjective patient outcome
2 secondary outcomes
Perioperative and postoperative complication rate
Revision rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus-Peter Guenther, Prof. principal investigator
Department of Orthopaedic Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Birmingham Hip Resurfacing in people with Arthritis, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolf-Christoph Witzleb, MD (+49 (0)351 4583323, Wolf-Christoph.Witzleb@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional result. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2006.