- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00804388
Wear Measurements of E-Poly in an Uncemented THA With Either 32 or 36 mm Caput of Ceramics.
Comparing Polyethylene Wear Using 3. Generation Highly Crosslinked Polyethylene in an Uncemented Total Hip Prostheses With Either 32 mm or 36 mm Caput of Ceramics
The aim of the study is to compare polyethylene wear in an uncemented total hip prosthesis with 3rd. generation highly cross-linked polyethylene with a 32 mm ceramic femoral head compared to a 36 mm ceramic head. Using X-ray, RSA and DEXA.
The polyethylene to be used is E-Poly (Biomet).
The H0 hypothesis is that there is no difference with regard to polyethylene wear and bone loss between the two groups.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway
- Lovisenberg Diakonale Sykehus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 50-65 years old
- Primary or secondary osteoarthritis
Exclusion Criteria:
- Significant anatomical divergence are excluded
- Rheumatoid arthritis
- Fracture sequelae
- Dysplasia
- Immune suppression or grave systemic illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
Uncemented total hip replacement, 32 mm caput
|
32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene
Other Names:
|
ACTIVE_COMPARATOR: 2
Uncemented total hip replacement, 36 mm caput
|
32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure polyethylene wear and bone mineral density between the two groups
Time Frame: 2 year
|
2 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Stephan M. Røhrl, MD,PhD, Ullevål Univeristy Hospital Norway
- Study Chair: Einar Lindalen, MD, Lovisenberg Diakonale Sykehus
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-08366a
- 03-2008 LDS
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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