Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings

Phase 4

Completed

• Conditions: Osteonecrosis; Osteoarthritis
• Interventions: Procedure: Ceramic on Highly crosslinked polyethylene bearing; Procedure: Ceramic on Ceramic bearing

• Registration Number: NCT01806766
• Lead Sponsor: Ewha Womans University

Brief Summary

The purpose of this prospective, randomized study was to compare the clinical and radiographic results and the prevalence of osteolysis of the cementless total hip arthroplasty with an alumina-on-alumina bearings one side and alumina-on-highly cross-linked polyethylene bearings on the other side in the young and active patients.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-01
• Primary Completion: 2000-01
• Study Completion: 2012-12
• Status Verified: 2013-03
• Study First Submitted: 2013-03-05
• Study First Submitted QC: 2013-03-06
• Last Update Submitted: 2013-03-06
• Study First Posted: 2013-03-07
• Last Update Posted: 2013-03-07

Recruitment & Eligibility

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

Inclusion Criteria

• Primary hip osteoarthritis
• Secondary hip osteoarthritis
• Avascular necrosis of femoral head

Exclusion Criteria

• Previous surgical history of hip

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ceramic on HXPE	Ceramic on Highly crosslinked polyethylene bearing	Ceramic on HIghly crosslinked polyethylene bearing coupled side of a single patient undergoing bilateral total hip arthroplasty
Ceramic on Ceramic	Ceramic on Ceramic bearing	Ceramic on Ceramic bearing coupled side of a single patient undergoing bilateral total hip arthroplasty

Primary Outcome Measures

Name	Time	Method
Harris hip score	Pre-op, last follow-up(11-13 years)	Comparing harris hip score before and after the intervention, and at the final follow-up, between two sides.

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)	preop, last follow-up(11-13 years)	WOMAC index before, and after the intervention, and between sides at the last follow-up

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of