Comparison of Highly Cross-Linked and Conventional Polyethylene in Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Total knee arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties
Exclusion Criteria:
- inflammatory arthritis
- osteoarthritis of the hip causing pain or restricted mobility
- a foot or ankle disorder which limited walking
- dementia or a neurological disorder including a past history of stroke which affected mobility
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional
Prolong
Arm Description
knee receiving Total knee arthroplasty with conventional polyethylene inserts
knee receiving total knee arthroplasty with highly cross linked polyethylene insert
Outcomes
Primary Outcome Measures
knee society knee score
clinical evaluation of knee function by knee score. This knee score will be compared, between preoperative and the latest score, and between the latest scores of study and control group.
Secondary Outcome Measures
range of motion
this value will be compared between preoperative and the latest value, and between the latest value of study and control groups
Full Information
NCT ID
NCT02020057
First Posted
December 13, 2013
Last Updated
December 18, 2013
Sponsor
Ewha Womans University
1. Study Identification
Unique Protocol Identification Number
NCT02020057
Brief Title
Comparison of Highly Cross-Linked and Conventional Polyethylene in Total Knee Arthroplasty
Official Title
Comparison of Highly Cross-Linked and Conventional Polyethylene in Posterior Cruciate-Substituting Total Knee Arthroplasty in the Same Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To our knowledge, there has been no information on in vivo clinical results of posterior cruciate-substituting arthroplasties using highly cross-linked polyethylene. We evaluated whether the clinical and radiographic results, incidence of post fracture of the tibial polyethylene insert, failure of the locking mechanism of the tibial polyethylene insert, and the incidence of osteolysis would be similar between posterior cruciate-substituting total knee prostheses using conventional and highly cross-linked polyethylene.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
319 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
knee receiving Total knee arthroplasty with conventional polyethylene inserts
Arm Title
Prolong
Arm Type
Experimental
Arm Description
knee receiving total knee arthroplasty with highly cross linked polyethylene insert
Intervention Type
Procedure
Intervention Name(s)
Total knee arthroplasty
Intervention Description
Total knee arthroplasty with standard incision and approach, and cement fixation. Zimmer Nexgen posterior stabilized total knee implants are used.
Primary Outcome Measure Information:
Title
knee society knee score
Description
clinical evaluation of knee function by knee score. This knee score will be compared, between preoperative and the latest score, and between the latest scores of study and control group.
Time Frame
3 months, 1 year, and yearly thereafter the operation, until 15 years after the operation
Secondary Outcome Measure Information:
Title
range of motion
Description
this value will be compared between preoperative and the latest value, and between the latest value of study and control groups
Time Frame
preoperative, 3 months, 1 year, and yearly thereafter the operation until 15 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties
Exclusion Criteria:
inflammatory arthritis
osteoarthritis of the hip causing pain or restricted mobility
a foot or ankle disorder which limited walking
dementia or a neurological disorder including a past history of stroke which affected mobility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Hoo Kim, M.D.
Organizational Affiliation
Ewha Womans University Mokdong Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Comparison of Highly Cross-Linked and Conventional Polyethylene in Total Knee Arthroplasty
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