All-Polyethylene Tibias in TKA: PS vs CS Implants

September 7, 2021 updated by: Lawson Health Research Institute

All-Polyethylene Tibial Components in Total Knee Arthroplasty: A Radiostereometric Analysis Comparing Posterior Stabilizing and Condylar Stabilizing Implants

This is a randomized control trial where patients will be randomized to receive one of two types of total knee arthroplasty (TKA) all-polyethylene (AP) tibial components: cruciate retaining (CR) or posterior stabilized (PS). We will use radiostereometric analysis to assess the stability of the implants at 6 weeks, 3 months, 6 months, 1 year and 2 year post-operatively. The main objective of this project will be to determine which AP tibial component offers the greatest stability. Additionally, we will seek to determine whether patient BMI significantly impacts the stability of AP tibial components.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

With healthcare expenditures rising as our population ages, there have been significant efforts targeted towards streamlining costs associated with various medical treatments. One area of substantial spending in the orthopaedic surgery field is total joint replacements. The effort to reduce costs has sparked a renewed interest in the use of allpolyethylene (AP) tibial components in total knee arthroplasty (TKA).

In recent years, there has been ample research demonstrating that AP tibial components have performed as good as, or better, than metal-backed (MB) tibial components. Some studies have estimated that cost savings could be as high as 50% with routine use of AP tibial components. While sufficient literature exists demonstrating the equivalence or superiority of AP versus MB designs, there is a paucity of work done comparing different types of AP tibial components.

Tibial components in TKA can be of the posterior stabilizing (PS) or cruciate retaining (CR) variety. To date, we are unaware of any study that directly compares AP tibial PS components to AP tibial CR components.

Radiostereometric analysis (RSA) has evolved as an exceptionally precise and reliable method for assessing the migration of components in total joint arthroplasty. Using RSA data, it is possible to accurately predict, within the first 24 months post-operatively, the survival of a total joint arthroplasty. Furthermore, the use of RSA outcomes in arthroplasty research allows for adequately powered studies with significantly smaller sample sizes than previously required.

The main objective of this project will be to determine which AP tibial component offers the greatest stability. Additionally, we will seek to determine whether patient body mass index (BMI) significantly impacts the stability of AP tibial components.

We will prospectively enroll patients who will be undergoing a total knee arthroplasty by one of the study investigators. Potentially eligible patients will have the project explained to them during their preadmission clinic visit prior to surgery and if interested a member of the research team will perform the informed consent process. Should a patient elect to participate in the study they will sign the informed consent form and complete demographics and baseline health related quality of life questionnaires including Oxford Knee, EQ-5D, and the VR-12, in addition to the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) which is already completed as per standard of care. The baseline demographic characteristics that will be collected include age, BMI, gender, and relevant medical comorbidities. Patients will be randomized to have either a PS or CR all-poly tibial component used during surgery. Randomization will be stratified by BMI to ensure equal distribution in both groups.

During surgery the surgeon will insert 6-9 tantalum beads in the proximal tibial, 6 beads in the polyeythylene tray, and another bead into the tip of the polyethylene stem. These beads will be used to measure migration of the implants on RSA imaging (radiostereometric analysis).

The RSA x-rays will be taken at baseline (2 weeks) and at the 6-week, 3 months, 6 months and 1 year and 2 year follow-up appointments. These images will be taken at Robarts Research Institute in the RSA analysis suite. At the 3month, 6 month, 1 year and 2 year visits we will also collect health related quality of life questionnaires including the WOMAC, Oxford Knee, EQ-5D and the VR-12.

Patients and data collector will be blinded to treatment arm. The person who will analyze the RSA images will be able to see which treatment arm participants belong to (based on viewing xrays) however the hypothesis of the study will not be revealed to them prior to analysis.

Intra-operative cost information will also be collected using institutional cost data in order to compare differences in OR costs between the two implant designs and across BMI categories.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5A5
        • London Health Sciences Centre - University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • osteoarthritis
  • primary total knee arthroplasty
  • able to consent for themself

Exclusion Criteria:

  • inflammatory arthropathy
  • fibromyalgia
  • chronic pain syndrome
  • previous distal femur or proximal tibia open reduction internal fixation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Posterior Stabilized
A posterior stabilized, all-polyethylene tibial component will be used during surgery.
Device: Posterior stabilized all-polyethylene tibial component
Patients randomized to this arm will have a Triathlon implant with a posterior stabilized, all-polyethylene tibial component used during surgery.
Active Comparator: Cruciate Retaining
A cruciate retaining, all-polyethylene tibial component will be used during surgery.
Device: Cruciate retaining all-polyethylene tibial component
Patients randomized to this arm will have a Triathlon implant with a cruciate retaining, all-polyethylene tibial component used during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Migration
Time Frame: Change between baseline (taken at 2 weeks post-operatively) and 2 years
Comparison of the two component types using radiostereometric analysis imaging.
Change between baseline (taken at 2 weeks post-operatively) and 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VR-12
Time Frame: 2 years
Patient-reported outcome used to assess general health.
2 years
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 2 years
Patient-reported outcome used to assess function, pain and stiffness.
2 years
Oxford Knee Score
Time Frame: 2 years
Patient-reported outcome used to assess knee function.
2 years
EQ-5D
Time Frame: 2 years
Patient-reported outcome used to assess quality of life.
2 years
Cost
Time Frame: Intraoperative
Intraoperative costs will be collected using institutional cost data.
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

University of Western Ontario, Canada

Investigators

  • Principal Investigator: Edward Vasarhelyi, MD, London Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

June 13, 2018

First Submitted That Met QC Criteria

June 23, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110812

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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