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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00804388
• Other study ID #: S-08366a
• Secondary ID: 03-2008 LDS
• Status: Active, not recruiting
• Phase: N/A
• First received: December 5, 2008
• Last updated: January 6, 2011
• Start date: December 2008
• Est. completion date: February 2012

Study information

• Verified date: January 2011
• Source: Lovisenberg Diakonale Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Directorate of HealthNorway: Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Primary Arthrosis

Intervention

Procedure:
• Total hip arthroplasty
32 mm versus 36 mm caput of ceramics Vitamin E stabilized polyethylene

Locations

Country	Name	City	State
Norway	Lovisenberg Diakonale sykehus	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Lovisenberg Diakonale Hospital	Biomet, Inc., Helse Sor-Ost, Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure polyethylene wear and bone mineral density between the two groups		2 year	Yes