ATTUNE Cementless CR Fixed Bearing for Osteoarthritis

Orthopaedic Specialty Institute, Irvine, CA
OsteoarthritisATTUNE Cementless CR Fixed Bearing - Device
Eligibility
22 - 80
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: 5 Years

1 Year
Functional Responder Rate All Subjects
Functional Responder Rate of first 225 Subjects
1 year
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
5 Years
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Investigator-conducted Radiographic Analysis
Kaplan-Meier Implant Survivorship
5 years
Forgotten Joint Score (FJS-12)
Knee
Knee Society Score
Year 5
Frequency of Adverse Events
Frequency of Device Deficiencies
Type of Adverse Events
Type of Device Deficiencies

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

ATTUNE Cementless CR Fixed Bearing
1 of 2
ATTUNE Cementless PS Fixed Bearing
1 of 2

Active Control

34 Total Participants · 2 Treatment Groups

Primary Treatment: ATTUNE Cementless CR Fixed Bearing · No Placebo Group · N/A

ATTUNE Cementless CR Fixed Bearing
Device
ActiveComparator Group · 1 Intervention: ATTUNE Cementless CR Fixed Bearing · Intervention Types: Device
ATTUNE Cementless PS Fixed Bearing
Device
ActiveComparator Group · 1 Intervention: ATTUNE Cementless PS Fixed Bearing · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

DePuy OrthopaedicsLead Sponsor
77 Previous Clinical Trials
25,616 Total Patients Enrolled
43 Trials studying Osteoarthritis
10,765 Patients Enrolled for Osteoarthritis
Allyson MorrisStudy DirectorDePuy Synthes
Paul VoorhorstStudy DirectorDePuy Synthes

Eligibility Criteria

Age 22 - 80 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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.

Who else is applying?

What state do they live in?
Pennsylvania50.0%
New Jersey50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University Orthopaedic Associates, LLC100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%
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."
How many prior treatments have patients received?
3+100.0%

Frequently Asked Questions

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

"This medical study welcomes volunteers between the age of 22 and 80." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.