Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Lovisenberg Diakonale Hospital.
Recruitment status was  Active, not recruiting
Helse Sor-Ost
Biomet, Inc.
Ullevaal University Hospital
Information provided by:
Lovisenberg Diakonale Hospital Identifier:
First received: December 5, 2008
Last updated: January 6, 2011
Last verified: January 2011

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.

Condition Intervention
Primary Arthrosis
Procedure: Total hip arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Lovisenberg Diakonale Hospital:

Primary Outcome Measures:
  • Measure polyethylene wear and bone mineral density between the two groups [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: December 2008
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: E-poly, Vitamine E, Hip, degenerative joint disease

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.

Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00804388

Lovisenberg Diakonale sykehus
Oslo, Norway
Sponsors and Collaborators
Lovisenberg Diakonale Hospital
Helse Sor-Ost
Biomet, Inc.
Ullevaal University Hospital
Study Chair: Stephan M. Røhrl, MD,PhD Ullevål Univeristy Hospital Norway
Study Chair: Einar Lindalen, MD Lovisenberg Diakonale sykehus
  More Information

Responsible Party: Einar Lindalen, MD, Lovisenberg Diakonale sykehus, Lovisenberg Diakonale sykehus Identifier: NCT00804388     History of Changes
Other Study ID Numbers: S-08366a  03-2008 LDS 
Study First Received: December 5, 2008
Last Updated: January 6, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Directorate of Health
Norway: Data Protection Authority

Keywords provided by Lovisenberg Diakonale Hospital:
Vitamine E
Degenerative joint disease

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Vitamin E
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents processed this record on October 27, 2016