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

Lovisenberg Diakonale Hospital

Status: Unknown

Conditions: Primary Arthrosis; Osteoarthritis

Treatments: Procedure: Total hip arthroplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00804388

03-2008 LDS

S-08366a

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Active Comparator group

Description:

Uncemented total hip replacement, 32 mm caput

Treatment:

Procedure: Total hip arthroplasty

2

Active Comparator group

Description:

Uncemented total hip replacement, 36 mm caput

Treatment:

Procedure: Total hip arthroplasty