Back to resultsComparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings
Primary Purpose
Osteonecrosis, Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ceramic on Ceramic bearing
Ceramic on Highly crosslinked polyethylene bearing
Sponsored by
About this trial
This is an interventional treatment trial for Osteonecrosis focused on measuring cementless total hip arthroplasty, ceramic on ceramic bearing, ceramic on highly cross linked polyethylene, young patient
Eligibility Criteria
Inclusion Criteria:
- Primary hip osteoarthritis
- Secondary hip osteoarthritis
- Avascular necrosis of femoral head
Exclusion Criteria:
- Previous surgical history of hip
Sites / Locations
- Ewha Womans University Mokdong Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ceramic on Ceramic
Ceramic on HXPE
Arm Description
Ceramic on Ceramic bearing coupled side of a single patient undergoing bilateral total hip arthroplasty
Ceramic on HIghly crosslinked polyethylene bearing coupled side of a single patient undergoing bilateral total hip arthroplasty
Outcomes
Primary Outcome Measures
Harris hip score
Comparing harris hip score before and after the intervention, and at the final follow-up, between two sides.
Secondary Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
WOMAC index before, and after the intervention, and between sides at the last follow-up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01806766
Brief Title
Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
January 2000 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteonecrosis, Osteoarthritis
Keywords
cementless total hip arthroplasty, ceramic on ceramic bearing, ceramic on highly cross linked polyethylene, young patient
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ceramic on Ceramic
Arm Type
Active Comparator
Arm Description
Ceramic on Ceramic bearing coupled side of a single patient undergoing bilateral total hip arthroplasty
Arm Title
Ceramic on HXPE
Arm Type
Active Comparator
Arm Description
Ceramic on HIghly crosslinked polyethylene bearing coupled side of a single patient undergoing bilateral total hip arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Ceramic on Ceramic bearing
Intervention Description
cementless Total Hip Arthroplasty with Ceramic on ceramic bearing
Intervention Type
Procedure
Intervention Name(s)
Ceramic on Highly crosslinked polyethylene bearing
Intervention Description
Cementless Total Hip Arthroplasty with Ceramic on Highly crosslinked polyethylene bearing
Primary Outcome Measure Information:
Title
Harris hip score
Description
Comparing harris hip score before and after the intervention, and at the final follow-up, between two sides.
Time Frame
Pre-op, last follow-up(11-13 years)
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Description
WOMAC index before, and after the intervention, and between sides at the last follow-up
Time Frame
preop, last follow-up(11-13 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary hip osteoarthritis
Secondary hip osteoarthritis
Avascular necrosis of femoral head
Exclusion Criteria:
Previous surgical history of hip
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Hoo Kim, MD
Organizational Affiliation
Ewha Womans University Mokdong Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings
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