Overview

This trial is active, not recruiting.

Conditions primary arthrosis, osteoarthritis
Treatment total hip arthroplasty
Sponsor Lovisenberg Diakonale Hospital
Collaborator Helse Sor-Ost
Start date December 2008
End date February 2012
Trial size 50 participants
Trial identifier NCT00804388, 03-2008 LDS, S-08366a

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Uncemented total hip replacement, 32 mm caput
total hip arthroplasty E-poly, Vitamine E, Hip, degenerative joint disease
32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene
(Active Comparator)
Uncemented total hip replacement, 36 mm caput
total hip arthroplasty E-poly, Vitamine E, Hip, degenerative joint disease
32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene

Primary Outcomes

Measure
Measure polyethylene wear and bone mineral density between the two groups
time frame: 2 year

Eligibility Criteria

Male or female participants from 50 years up to 65 years old.

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

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by Lovisenberg Diakonale Hospital.