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

January 6, 2011 updated by: Lovisenberg Diakonale Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Lovisenberg Diakonale Sykehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Uncemented total hip replacement, 32 mm caput
Procedure: Total hip arthroplasty
32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene
Other Names:
  • E-poly, Vitamine E, Hip, degenerative joint disease
ACTIVE_COMPARATOR: 2
Uncemented total hip replacement, 36 mm caput
Procedure: Total hip arthroplasty
32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene
Other Names:
  • E-poly, Vitamine E, Hip, degenerative joint disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure polyethylene wear and bone mineral density between the two groups
Time Frame: 2 year
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lovisenberg Diakonale Hospital

Collaborators

Ullevaal University Hospital
Zimmer Biomet
Helse Sor-Ost

Investigators

  • Study Chair: Stephan M. Røhrl, MD,PhD, Ullevål Univeristy Hospital Norway
  • Study Chair: Einar Lindalen, MD, Lovisenberg Diakonale Sykehus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ANTICIPATED)

February 1, 2012

Study Completion (ANTICIPATED)

February 1, 2012

Study Registration Dates

First Submitted

December 5, 2008

First Submitted That Met QC Criteria

December 5, 2008

First Posted (ESTIMATE)

December 8, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 7, 2011

Last Update Submitted That Met QC Criteria

January 6, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-08366a
  • 03-2008 LDS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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