Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement

Odense University Hospital

Status: Active, not recruiting

Conditions: Osteoarthritis, Hip; Osteoarthritis

Treatments: Device: E-Poly liner; Device: ArComXL liner; Device: 36 mm femoral head; Device: 32 mm femoral head

Study type: Interventional

Funder types: Other

Identifiers

NCT02196792

project-ID S-20080151

Details and patient eligibility

About

The objective of the study is to investigate head penetration, cup migration, and clinical outcome in total hip replacements using a factorial design. Treatment groups are E-Poly versus ArComXL liners, and 36 mm versus 32 mm head size.

Enrollment: 100 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary idiopathic arthritis,
• Eligible for uncemented total hip arthroplasty
• 40 to70 years of age,
• Cup size of 54mm and above

Exclusion criteria

• Anteversion where non-standard stem can be used,
• Dysplasia (Center-edge angle of Wiberg < 20°),
• Malignant condition
• Prior radiotherapy
• Physical or psychological condition that renders it impossible for the patient to take part in our usual rehabilitation programme (as stated in the department's standard operation procedure),
• Complications during surgery (requiring screws in shell or femoral cerclage)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups

E-Poly/32 mm

Active Comparator group

Description:

E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head.

Treatment:

Device: 32 mm femoral head

Device: E-Poly liner

E-Poly/36 mm

Active Comparator group

Description:

E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.

Treatment:

Device: 36 mm femoral head

Device: E-Poly liner

ArComXL/32 mm

Active Comparator group

Description:

ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head.

Treatment:

Device: 32 mm femoral head

Device: ArComXL liner

ArComXL/36 mm

Active Comparator group

Description:

ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.

Treatment:

Device: 36 mm femoral head

Device: ArComXL liner