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Orthopedic Implant

ATTUNE Cementless CR Fixed Bearing for Osteoarthritis

N/A
Waitlist Available
Research Sponsored by DePuy Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has a severely painful knee and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant provided that adequate bone is present.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial will observe patients who have had the Attune Cementless Femur Tray (primary or revision procedures) to see if they meet the functional responder criteria.

Eligible Conditions
  • Osteoarthritis of the Knee

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a very painful knee that makes it difficult for you to move around due to a previous injury, arthritis, or a previous knee implant that did not work. However, if there is enough bone present, you may still be eligible.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Functional Responder Rate of first 225 Subjects
Secondary outcome measures
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Forgotten Joint Score (FJS-12)
Frequency of Adverse Events
+9 more

Trial Design

2Treatment groups
Active Control
Group I: ATTUNE Cementless CR Fixed BearingActive Control1 Intervention
Subjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Cruciate Retaining Configuration.
Group II: ATTUNE Cementless PS Fixed BearingActive Control1 Intervention
Subjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Posterior Stabilizing Configuration.

Find a Location

Who is running the clinical trial?

DePuy OrthopaedicsLead Sponsor
78 Previous Clinical Trials
25,637 Total Patients Enrolled
44 Trials studying Osteoarthritis
10,879 Patients Enrolled for Osteoarthritis
Paul VoorhorstStudy DirectorDePuy Synthes
Allyson MorrisStudy DirectorDePuy Synthes
1 Previous Clinical Trials
1,542 Total Patients Enrolled
1 Trials studying Osteoarthritis
1,542 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

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

Is there an age cap for those wishing to join this experiment?

"This medical study welcomes volunteers between the age of 22 and 80."

Answered by AI

How many participants would be included in this research study?

"600 individuals who fit the pre-determined criteria must be engaged to effectively complete this research. DePuy Orthopaedics will oversee operations at several facilities, including American Hip Institute & Orthopedic Specialists in Chicago and Loyola University Medical Center near Maywood."

Answered by AI

What is the geographical scope of this experiment?

"This trial is currently being conducted at the American Hip Institute & Orthopedic Specialists in Chicago, Illinois, Loyola University Medical Center in Maywood, Maryland and the University of Missouri in Columbia Michigan as well as 12 other sites."

Answered by AI

Is the patient enrollment period for this experiment open?

"Affirmative. Clinicaltrials.gov's records suggest that enrollment for this clinical trial is open, beginning on May 9th 2022 and most recently updated November 28th 2022. The study seeks 600 volunteers distributed across 15 distinct sites."

Answered by AI

Is it possible for me to become part of this medical research?

"The requirements for inclusion in this medical experiment stipulate that individuals must be between 22 and 80 years old, as well as have a diagnosis of arthrosis. 600 patients are needed to take part."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
University Orthopaedic Associates, LLC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tried synvisc and cortisone injections, meloxocam, and physical therapy. Things are getting worse and worse - but I don't want double (or any) knee replacements.
PatientReceived 1 prior treatment
~12 spots leftby Mar 2025