Status:
TERMINATED
Polymethyl Methacrylate and (PEGT/PBT) Centralizer by the Uncemented BIHAPRO THP
Lead Sponsor:
Biomet Nederland BV
Collaborating Sponsors:
Atrium Medical Center
Conditions:
Osteoarthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to analyse if the alignment of the stem and the number of complications of the new resorbable PEGT/PBT centralizer are comparable to the standard PMMA centralizer during t...
Detailed Description
For a correct placement and early fixation of an uncemented hip prosthesis, a centralizer is used. Normally, the centralizer is made of PMMA, the same material as bone cement. When a revision is neede...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years
- Diagnosis: Osteoarthritis
- Indicated for a primary hip prosthesis
Exclusion
- Previous hip surgery
- No informed consent
- Active infection in hip
- Immature skeleton
- Rheumatoid arthritis, M. Paget
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00214760
Start Date
May 1 2005
End Date
September 1 2011
Last Update
February 1 2010
Active Locations (1)
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1
Atrium medical centre
Heerlen, Netherlands, 6401CX