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

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

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.

Study Overview

• Status: Unknown
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: Device: knee arthroplasty, standard polyethylene; Device: knee arthroplasty, XLP polyethylene

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Chapel Hill Orthopedic Surgery and Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all female and male patients with arthritis of knee that requires total knee arthroplasty

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
knee arthroplasty, standard polyethylene; total knee arthroplasty with Standard Compression Molded tibial Polyethylene Liner	Device: knee arthroplasty, standard polyethylene; total knee replacement follow-up; clinical and radiographic; revision rate; Other Names: Zimmer
knee arthroplasty, Highly Cross-Linked (XLP) polyethylene; knee arthroplasty with Highly Cross-Linked tibial Polyethylene Liner	Device: knee arthroplasty, XLP polyethylene; total knee arthroplasty with highly crosslinked polyethylene tibial liner; Other Names: Zimmer: Prolong

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants requiring revision, or with Device Related Serious Adverse Events	reoperation rate; polyethylene fracture/failure rate	Up to 10 years
Radiographic osteolysis	lucent, periarticular lesions , related to polyethylene wear	up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
knee scores	Knee Society Pain and Function scores	up to 10 years
knee joint effusion	knee joint examination	up to 10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
LEAS (lower extremity activity score)	patient completed activity questionaire	up to 10 years

Collaborators and Investigators

• Sponsor: Chapel Hill Orthopedics Surgery & Sports Medicine
• Collaborators: Zimmer Biomet
• Investigators: Principal Investigator: Paul F Lachiewicz, MD, Chapel Hill Orthopedic Surgery and Sports Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: June 23, 2014
• First Submitted That Met QC Criteria: June 26, 2014
• First Posted (Estimate): June 30, 2014

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Knee Arthroplasty; Osteolysis; Radiolucent Lines
• Other Study ID Numbers: 05017.0501399RC05