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

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ClinicalTrials.gov Identifier: NCT00804388
Recruitment Status : Unknown
Verified January 2011 by Lovisenberg Diakonale Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2008
Last Update Posted : January 7, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Primary Arthrosis Osteoarthritis Procedure: Total hip arthroplasty

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2008
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 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


Outcome Measures

Primary Outcome Measures :
  1. Measure polyethylene wear and bone mineral density between the two groups [ Time Frame: 2 year ]

Eligibility Criteria

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Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804388


Locations
Norway
Lovisenberg Diakonale sykehus
Oslo, Norway
Sponsors and Collaborators
Lovisenberg Diakonale Hospital
Helse Sor-Ost
Zimmer Biomet
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

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
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: January 7, 2011
Last Verified: January 2011

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

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