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
Sponsor:
Collaborators:
Helse Sor-Ost
Biomet, Inc.
Ullevaal University Hospital
Information provided by:
Lovisenberg Diakonale Hospital
ClinicalTrials.gov Identifier:
NCT00804388
First received: December 5, 2008
Last updated: January 6, 2011
Last verified: January 2011
  Purpose

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
Osteoarthritis
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.

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00804388

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

No publications provided

Responsible Party: Einar Lindalen, MD, Lovisenberg Diakonale sykehus, Lovisenberg Diakonale sykehus
ClinicalTrials.gov 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
E-poly
Hip
Degenerative joint disease

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 25, 2014