Comparison of Highly Cross-Linked and Conventional Polyethylene in Posterior Cruciate-Substituting Total Knee Arthroplasty in the Same Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ewha Womans University
- Enrollment
- 319
- Primary Endpoint
- knee society knee score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Conventional
knee receiving Total knee arthroplasty with conventional polyethylene inserts
Intervention: Total knee arthroplasty (Procedure)
Prolong
knee receiving total knee arthroplasty with highly cross linked polyethylene insert
Intervention: Total knee arthroplasty (Procedure)
Outcomes
Primary Outcomes
knee society knee score
Time Frame: 3 months, 1 year, and yearly thereafter the operation, until 15 years after the operation
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 Outcomes
- range of motion(preoperative, 3 months, 1 year, and yearly thereafter the operation until 15 years)
Investigators
Young Hoo Kim
Professor
Ewha Womans University