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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00804388

Enrollment

Registered

2008-12-08

Start date

2008-12-31

Completion date

2012-02-29

Last updated

2011-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Primary Arthrosis

Keywords

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

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.

Interventions

PROCEDURETotal hip arthroplasty

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026