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All-Polyethylene Tibias in TKA: PS vs CS Implants

NCT03569670 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-09-14

No results posted yet for this study

Summary

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.

Conditions

  • Osteoarthritis, Knee

Interventions

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.

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.

Sponsors & Collaborators

  • University of Western Ontario, Canada

    collaborator OTHER

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Edward Vasarhelyi, MD · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03569670 on ClinicalTrials.gov