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

Lovisenberg Diakonale Hospital50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Arthrosis Osteoarthritis

Interventions

Total hip arthroplastyPROCEDURE

32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene

Eligibility

Sex: ALLMin age: 50 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 (1)

Lovisenberg Diakonale sykehus

Oslo, Norway

Outcomes

Primary Outcomes

Measure polyethylene wear and bone mineral density between the two groups

Time frame: 2 year

Data from ClinicalTrials.gov

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