Wear Measurements of E-Poly in an Uncemented THA With Either 32 or 36 mm Caput of Ceramics.

Not Applicable

• Conditions: Primary Arthrosis; Osteoarthritis
• Interventions: Procedure: Total hip arthroplasty

• Registration Number: NCT00804388
• Lead Sponsor: Lovisenberg Diakonale Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-05
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-06
• Last Update Posted: 2011-01-07
• Primary Completion: 2012-02
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Total hip arthroplasty	Uncemented total hip replacement, 32 mm caput
2	Total hip arthroplasty	Uncemented total hip replacement, 36 mm caput

Primary Outcome Measures

Name	Time	Method
Measure polyethylene wear and bone mineral density between the two groups	2 year

Trial Locations

Locations (1)

Lovisenberg Diakonale sykehus; 🇳🇴 Oslo, Norway