Outcome Study of Highly-cross Linked Polyethylene vs. Standard Polyethylene for Primary Posterior Stabilized (PS) Total Knee

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Prospective, Randomized Study of Highly-cross Linked Polyethylene vs. Compression Molded Polyethylene for Primary Posterior-stabilized Total Knee Arthroplasty

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02178020
• Other study ID #: 05017.0501399RC05
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 23, 2014
• Last updated: January 31, 2017
• Start date: July 2009
• Est. completion date: July 2019

Study information

• Verified date: January 2017
• Source: Chapel Hill Orthopedics Surgery & Sports Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Polyethylene wear and osteolysis remain a concern with the use of modular, fixed bearing total knee arthroplasty. A variety of highly cross-linked polyethylenes have been introduced to decrease this problem, but there is little data on the results and complications of this polyethylene in posterior-stabilized knee prosthesis. The investigators asked the following questions: (1) Are there any differences in the clinical and radiographic results when a highly cross-lined polyethylene is compared to a standard liner? (2) What is the frequency of reoperation in these two groups and are there any specific complications related to highly cross-linked polyethylene liners.

Description:

This prospective, randomized study will seek to enroll patients undergoing primary total knee arthroplasty. Preoperative evaluation will include a detailed history and physical exam with clinical data collection (SF-36, WOMAC, and Knee Society Scores), a complete description of the procedure, a demonstration of the actual types of implants and tibial inserts, and an outline of the study protocol and informed consent. Intraoperatively, the patient will undergo a total knee arthroplasty utilizing standard operative procedures. Each patient will receive a Zimmer NexGen posterior-stabilized total knee arthroplasty. During the procedure or preoperative visit, the patient will be randomized by sealed envelope to receive either a standard Zimmer UHMWPE tibial insert or a Zimmer highly cross-linked UHMWPE tibial insert. Both surgeon and patient will be blinded to the type of implant used. there will be no variations in surgical technique and hospital management of the patients throughout the course of the study. Postoperatively, the patient will be seen for routine follow-up at six weeks, 6 months, 1 year and yearly thereafter. Radiographs will be obtained at each visit. Clinical data forms will be completed at each visit. At the conclusion of the study radiographs will be assessed for signs of polyethylene wear, osteolysis and component loosening. the preoperative and postoperative knee scores will be calculated for each patient and compared between the patient groups with standard statistical analysis.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients indicated for primary total posterior stabilized knee arthroplasty

Exclusion Criteria:

• patients who refused participation

• patients who did not comprehend the English language to give informed consent

• patients with severe knee deformity thought to require a primary constrained condylar prosthesis

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Device:
• knee arthroplasty, standard polyethylene
total knee replacement follow-up; clinical and radiographic; revision rate
• knee arthroplasty, XLP polyethylene
total knee arthroplasty with highly crosslinked polyethylene tibial liner

Locations

Country	Name	City	State
United States	Chapel Hill Orthopedic Surgery and Sports Medicine	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Chapel Hill Orthopedics Surgery & Sports Medicine	Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	LEAS (lower extremity activity score)	patient completed activity questionaire	up to 10 years
Primary	Number of Participants requiring revision, or with Device Related Serious Adverse Events	reoperation rate; polyethylene fracture/failure rate	Up to 10 years
Primary	Radiographic osteolysis	lucent, periarticular lesions , related to polyethylene wear	up to 10 years
Secondary	knee scores	Knee Society Pain and Function scores	up to 10 years
Secondary	knee joint effusion	knee joint examination	up to 10 years