Comparison of Highly Cross-Linked and Conventional Polyethylene in Total Knee Arthroplasty
2 other identifiers
interventional
319
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2006
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 13, 2013
CompletedFirst Posted
Study publicly available on registry
December 24, 2013
CompletedDecember 24, 2013
December 1, 2013
4.5 years
December 13, 2013
December 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 months, 1 year, and yearly thereafter the operation, until 15 years after the operation
Secondary Outcomes (1)
range of motion
preoperative, 3 months, 1 year, and yearly thereafter the operation until 15 years
Study Arms (2)
Conventional
ACTIVE COMPARATORknee receiving Total knee arthroplasty with conventional polyethylene inserts
Prolong
EXPERIMENTALknee receiving total knee arthroplasty with highly cross linked polyethylene insert
Interventions
Total knee arthroplasty with standard incision and approach, and cement fixation. Zimmer Nexgen posterior stabilized total knee implants are used.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Young-Hoo Kim, M.D.
Ewha Womans University Mokdong Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 13, 2013
First Posted
December 24, 2013
Study Start
February 1, 2006
Primary Completion
August 1, 2010
Study Completion
September 1, 2013
Last Updated
December 24, 2013
Record last verified: 2013-12