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Comparison of Highly Cross-Linked and Conventional Polyethylene in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02020057
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : December 24, 2013
Sponsor:
Information provided by (Responsible Party):
Young Hoo Kim, Ewha Womans University

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Procedure: Total knee arthroplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 319 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Highly Cross-Linked and Conventional Polyethylene in Posterior Cruciate-Substituting Total Knee Arthroplasty in the Same Patients
Study Start Date : February 2006
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2013


Arm Intervention/treatment
Active Comparator: Conventional
knee receiving Total knee arthroplasty with conventional polyethylene inserts
Procedure: Total knee arthroplasty
Total knee arthroplasty with standard incision and approach, and cement fixation. Zimmer Nexgen posterior stabilized total knee implants are used.

Experimental: Prolong
knee receiving total knee arthroplasty with highly cross linked polyethylene insert
Procedure: Total knee arthroplasty
Total knee arthroplasty with standard incision and approach, and cement fixation. Zimmer Nexgen posterior stabilized total knee implants are used.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. range of motion [ Time Frame: preoperative, 3 months, 1 year, and yearly thereafter the operation until 15 years ]
    this value will be compared between preoperative and the latest value, and between the latest value of study and control groups



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020057


Sponsors and Collaborators
Ewha Womans University
Investigators
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Study Director: Young-Hoo Kim, M.D. Ewha Womans University Mokdong Hospital
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Responsible Party: Young Hoo Kim, Professor, Ewha Womans University
ClinicalTrials.gov Identifier: NCT02020057    
Other Study ID Numbers: PSXL
2006-32 ( Other Identifier: Institutional Review Board, Dongdaemun Hospital )
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases