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

NCT00804388 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-01-07

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Total hip arthroplasty

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

Sponsors & Collaborators

  • Helse Sor-Ost

    collaborator OTHER_GOV

  • Zimmer Biomet

    collaborator INDUSTRY

  • Ullevaal University Hospital

    collaborator OTHER

  • Lovisenberg Diakonale Hospital

    lead OTHER

Principal Investigators

  • Stephan M. Røhrl, MD,PhD · Ullevål Univeristy Hospital Norway

  • Einar Lindalen, MD · Lovisenberg Diakonale sykehus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00804388 on ClinicalTrials.gov