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

Osteoarthritis, Knee Clinical Trial

Official title:

Comparison of Highly Cross-Linked and Conventional Polyethylene in Posterior Cruciate-Substituting Total Knee Arthroplasty in the Same Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020057
• Other study ID #: PSXL
• Secondary ID: 2006-32
• Status: Completed
• Phase: N/A
• First received: December 13, 2013
• Last updated: December 18, 2013
• Start date: February 2006
• Est. completion date: September 2013

Study information

• Verified date: December 2013
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: September 2013
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Procedure:
• Total knee arthroplasty
Total knee arthroplasty with standard incision and approach, and cement fixation. Zimmer Nexgen posterior stabilized total knee implants are used.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	range of motion	this value will be compared between preoperative and the latest value, and between the latest value of study and control groups	preoperative, 3 months, 1 year, and yearly thereafter the operation until 15 years	No