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

Not Applicable

Active, not recruiting

• Conditions: Osteoarthritis, Hip; Osteoarthritis
• Interventions: Device: E-Poly liner; Device: ArComXL liner; Device: 36 mm femoral head; Device: 32 mm femoral head

• Registration Number: NCT02196792
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-01
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-20
• Study First Posted: 2014-07-22
• Primary Completion: 2015-05-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-17
• Last Update Posted: 2022-06-21
• Study Completion: 2030-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
E-Poly/36 mm	E-Poly liner	E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
E-Poly/36 mm	36 mm femoral head	E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
ArComXL/36 mm	ArComXL liner	ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
ArComXL/36 mm	36 mm femoral head	ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
ArComXL/32 mm	ArComXL liner	ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head.
E-Poly/32 mm	32 mm femoral head	E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head.
ArComXL/32 mm	32 mm femoral head	ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head.
E-Poly/32 mm	E-Poly liner	E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head.

Primary Outcome Measures

Name	Time	Method
Mean head penetration from baseline to 5 year follow-up	From baseline to 5 years	Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up

Secondary Outcome Measures

Name	Time	Method
Mean change in clinical outcome score from baseline to 5 year follow-up	From baseline to 5 years	Mean change in patient-reported hip function (Harris Hip Score), quality of life (EQ-5D and SF-36), and patient activity (UCLA Activity Score).
Mean cup migration form baseline to 5 year follow-up	From baseline to 5 years	Mean cup migration assessed using RSA from baseline to 5 year follow-up

Trial Locations

Locations (1)

Joseph Abdalla Nommesen El-Sahoury; 🇩🇰 Odense C, Syddanmark, Denmark