Wear Measurements of E-Poly in an Uncemented THA With Either 32 or 36 mm Caput of Ceramics.
Information source: Lovisenberg Diakonale Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Arthrosis; Degenerative Joint Disease
Intervention: Total hip arthroplasty (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Lovisenberg Diakonale Hospital Official(s) and/or principal investigator(s):
Stephan M. Røhrl, MD,PhD, Study Chair, Affiliation: Ullevål Univeristy Hospital Norway
Einar Lindalen, MD, Study Chair, Affiliation: Lovisenberg Diakonale sykehus
Overall contact:
Einar Lindalen, MD, Phone: +47 23 22 50 00, Email: eli@lds.no
Summary
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.
Clinical Details
Official title: Comparing Polyethylene Wear Using 3. Generation Highly Crosslinked Polyetylene in an Uncemented Total Hip Prostheses With Either 32 mm or 36 mm Caput of Ceramics
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Measure polyethylene wear and bone mineral density between the two goups
Detailed description:
Uncemented THA, 32 mm or 36 mm caput of ceramics, E-Poly inserts. Measure wear with RSA,
X-Ray and bone mineral density with DEXA.
Eligibility
Minimum age: 50 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Einar Lindalen, MD, Phone: +47 23 22 50 00, Email: eli@lds.no
Lovisenberg Diakonale sykehus, Oslo, Norway; Recruiting
Einar Lindalen, MD, Phone: +47 23 22 50 00, Email: eli@lds.no
Stephan M. Røhrl, MD,PhD, Phone: +47 22 11 80 80, Email: s.m.rohrl@medisin.uio.no
Einar Lindalen, MD, Principal Investigator
Additional Information
Starting date: December 2008
Ending date: January 2011
Last updated: December 5, 2008
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