Standard implants for Knee

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Knee+2 More
ATTUNE PS Knee - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is comparing the Attune and Attune S+ PS knee systems to see which one has better migration patterns. It will also look at changes in function and health status, as well as any complications that occur after surgery.

Eligible Conditions
  • Knee

Treatment Effectiveness

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 2 Years

2 Years
RSA Migration
Preoperative
Knee Replacement Expectation Survey (KRES)
Preoperative and 1 Year
Pain Catastrophizing Scale (PCS)
Year 2
Patient complications
Year 2
Patient satisfaction
Pre-operative Patient's Knee Implant Performance (PKIP)
Year 2
University of California at Los Angeles (UCLA) Activity Level scale
Year 2
European Quality of Life (EQ-5D-5L)
Oxford 12 Knee
Pain score

Trial Safety

Trial Design

2 Treatment Groups

Standard implants
1 of 2
Enhanced-Fixation
1 of 2
Active Control

50 Total Participants · 2 Treatment Groups

Primary Treatment: Standard implants · No Placebo Group · N/A

Standard implants
Device
ActiveComparator Group · 1 Intervention: ATTUNE PS Knee · Intervention Types: Device
Enhanced-Fixation
Device
ActiveComparator Group · 1 Intervention: ATTUNE S+ PS Knee · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Orthopaedic Innovation CentreOTHER
5 Previous Clinical Trials
637 Total Patients Enrolled
Dalhousie UniversityOTHER
152 Previous Clinical Trials
341,287 Total Patients Enrolled
London Health Sciences CentreOTHER
135 Previous Clinical Trials
47,481 Total Patients Enrolled
Canadian Radiostereometric Analysis NetworkLead Sponsor
4 Previous Clinical Trials
198 Total Patients Enrolled
Douglas Naudie, MD FRCSCPrincipal InvestigatorLondon Health Sciences Centre
Glen Richardson, MD MSc FRCSCPrincipal InvestigatorDalhousie University
Thomas Turgeon, MD MPH FRCSCPrincipal InvestigatorUniversity of Manitoba
1 Previous Clinical Trials
54 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have symptomatic osteoarthritis of the knee and are aged 50 years or older.
You are willing and able to comply with follow-up requirements and self-evaluations.
You have the ability to give informed consent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: October 5th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.