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

Osteoarthritis Clinical Trial

Official title:

Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings in Primary Cementless Total Hip Arthroplasty in the Same Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806766
• Other study ID #: XPECCC
• Status: Completed
• Phase: Phase 4
• First received: March 5, 2013
• Last updated: March 6, 2013
• Start date: January 1998
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: January 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary hip osteoarthritis

• Secondary hip osteoarthritis

• Avascular necrosis of femoral head

Exclusion Criteria:

• Previous surgical history of hip

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteonecrosis

Intervention

Procedure:
• Ceramic on Ceramic bearing
cementless Total Hip Arthroplasty with Ceramic on ceramic bearing
• Ceramic on Highly crosslinked polyethylene bearing
Cementless Total Hip Arthroplasty with Ceramic on Highly crosslinked polyethylene bearing

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris hip score	Comparing harris hip score before and after the intervention, and at the final follow-up, between two sides.	Pre-op, last follow-up(11-13 years)	No
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)	WOMAC index before, and after the intervention, and between sides at the last follow-up	preop, last follow-up(11-13 years)	No