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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Arthrosis Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Uncemented total hip replacement, 32 mm caput

Group Type ACTIVE_COMPARATOR

Total hip arthroplasty

Intervention Type PROCEDURE

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

2

Uncemented total hip replacement, 36 mm caput

Group Type ACTIVE_COMPARATOR

Total hip arthroplasty

Intervention Type PROCEDURE

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

Interventions

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Total hip arthroplasty

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

Intervention Type PROCEDURE

Other Intervention Names

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E-poly, Vitamine E, Hip, degenerative joint disease

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No