- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00284674
Prospective Clinical Evaluation of Three Prosthesis Re-cap, M2a-Magnum and C2a-taper.
March 22, 2017 updated by: Arne Borgwardt, Frederiksberg University Hospital
This evaluation is being conducted to evaluate the performance of thee prosthesis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Frederiksberg
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Copenhagen, Frederiksberg, Denmark, 2000
- Frederiksberg University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Good general health of age (ASA I-II)
- DEXA-scanning: lower limit for a 55 years old man
- MRI normal vitality in caput
- Willing to return for follow-up evaluations
- Exclusion Criteria:
- Subjects displaying any of the following contra-indications shall be excluded from this evaluation:
- Inability to co-operate with and complete the study
- Collum < 2 cm
- Large cysts in caput
- Mismatch between caput acetabulum
- Caput necrosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Arne Borgwardt, M.D., Frederiksberg University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2006
Primary Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
January 31, 2006
First Submitted That Met QC Criteria
January 31, 2006
First Posted (Estimate)
February 1, 2006
Study Record Updates
Last Update Posted (Actual)
March 24, 2017
Last Update Submitted That Met QC Criteria
March 22, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- KF-01-287.591
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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