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Traditional Device

ATTUNE Knee Systems for Osteoarthritis

N/A

Waitlist Available

Led By Douglas Naudie, MD FRCSC

Research Sponsored by Canadian Radiostereometric Analysis Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

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.

Who is the study for?

This trial is for adults aged 21-80 with knee osteoarthritis who need a total knee replacement and can follow the study's procedures. People with conditions that make major surgery risky or those with active or past infections in the knee are not eligible.Check my eligibility

What is being tested?

The study aims to compare how two different knee replacement devices, ATTUNE PS Knee and ATTUNE S+ PS Knee, stay in place over two years after surgery. It will also look at changes in patients' function and health status post-surgery.See study design

What are the potential side effects?

While specific side effects aren't listed, typical risks of knee replacement may include pain, swelling, infection risk at the surgical site, blood clots, implant loosening or wear over time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

RSA Migration

Secondary outcome measures

European Quality of Life (EQ-5D-5L)

Knee Replacement Expectation Survey (KRES)

Oxford 12 Knee

+6 more

Trial Design

2Treatment groups

Active Control

Group I: Standard implantsActive Control1 Intervention

ATTUNE PS Knee

Group II: Enhanced-FixationActive Control1 Intervention

ATTUNE S+ PS Knee

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

London Health Sciences CentreOTHER

142 Previous Clinical Trials

49,868 Total Patients Enrolled

1 Trials studying Osteoarthritis

192 Patients Enrolled for Osteoarthritis

Canadian Radiostereometric Analysis NetworkLead Sponsor

7 Previous Clinical Trials

345 Total Patients Enrolled

3 Trials studying Osteoarthritis

113 Patients Enrolled for Osteoarthritis

Orthopaedic Innovation CentreOTHER

5 Previous Clinical Trials

595 Total Patients Enrolled

2 Trials studying Osteoarthritis

364 Patients Enrolled for Osteoarthritis

Media Library

ATTUNE PS Knee (Traditional Device) Clinical Trial Eligibility Overview. Trial Name: NCT03554720 — N/A

Osteoarthritis Research Study Groups: Standard implants, Enhanced-Fixation

Osteoarthritis Clinical Trial 2023: ATTUNE PS Knee Highlights & Side Effects. Trial Name: NCT03554720 — N/A

ATTUNE PS Knee (Traditional Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03554720 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the enrollment criteria of this clinical trial encompass those aged 55 and above?

"This trial is seeking participants between the ages of 21 and 80."

Answered by AI

Who is eligible to participate in this research experiment?

"This study has established an age range of 21 to 80 years old for prospective participants, and is currently accepting applications from those suffering with knee-related issues. The total enrolment goal is 50 individuals."

Answered by AI

Is this research endeavor in need of new participants?

"This trial, which was made available on 7/4/2018 and most recently updated on 9/26/2022, is not currently recruiting participants. Fortunately there are 693 other studies that remain open for recruitment at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs

2018. "RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03554720.