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Cementless Knee Replacement 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 was diagnosed with NIDJD
Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-op (-90 to -1 days before surgery), 6 weeks (1-90 days after surgery), 6 months (91-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-1033 days after surgery), minimum 5 years (1764-2190 days after surgery)
Awards & highlights
Study Summary
This trial will compare two types of cementless TKA RP systems to see which results in better functional performance as measured by the KOOS questionnaire.
Who is the study for?
This trial is for men and women aged 22-80 who are not bedridden, can consent to the study, understand procedures, complete questionnaires in English or translations provided, diagnosed with non-inflammatory degenerative joint disease (NIDJD), and suitable for cementless knee replacement. Exclusions include recent participation in other trials, litigation involvement, inflammatory arthritis conditions, life expectancy under five years, pregnancy/lactation status among others.Check my eligibility
What is being tested?
The ATTUNE Cementless Total Knee Arthroplasty (TKA) system's performance is being tested. Specifically looking at functional improvements two years after surgery using the KOOS questionnaire. It compares cruciate retaining rotating platform and posterior stabilized rotating platform configurations of the TKA system.See study design
What are the potential side effects?
While specific side effects are not listed here for this surgical intervention trial involving a cementless knee prosthesis system like ATTUNE TKA RP systems generally may have risks including pain at the site of surgery, infection risk post-operation, blood clots formation potential in legs or lungs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a non-inflammatory joint disease.
Select...
I am between 22 and 80 years old.
Select...
I am not confined to bed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-op (-90 to -1 days before surgery), 6 weeks (1-90 days after surgery), 6 months (91-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-1033 days after surgery), minimum 5 years (1764-2190 days after surgery)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-op (-90 to -1 days before surgery), 6 weeks (1-90 days after surgery), 6 months (91-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-1033 days after surgery), minimum 5 years (1764-2190 days after surgery)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)
Secondary outcome measures
Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011
Evaluate changes in femoral component and tibial component alignment
Implant fixation: Radiographic assessment of bone-implant interface performance
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ATTUNE Cementless RP TKAExperimental Treatment1 Intervention
Subjects will receive a cementless, rotating platform total knee arthroplasty
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cementless Total Knee Arthroplasty
2017
N/A
~90
Find a Location
Who is running the clinical trial?
DePuy OrthopaedicsLead Sponsor
79 Previous Clinical Trials
25,299 Total Patients Enrolled
44 Trials studying Osteoarthritis
10,373 Patients Enrolled for Osteoarthritis
Sukhjeet KaurStudy DirectorSponsor GmbH
1 Previous Clinical Trials
400 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have pain from my spine that spreads to the limb getting knee replacement.I am currently pregnant or breastfeeding.I have been diagnosed with a non-inflammatory joint disease.I have had surgery on my knee before, like a partial replacement or other specific procedures.I am diagnosed with a muscular disorder like fibromyalgia and take prescription medication for it.I have a condition like MS that affects my walking or ability to bear weight.I am between 22 and 80 years old.I understand the study and agree to follow all procedures and visits.My doctor thinks I am a good candidate for a specific knee replacement surgery without cement.I am not confined to bed.I have gout that is not managed by my current treatment.I have a type of inflammatory arthritis like rheumatoid or psoriatic arthritis.I have had an amputation on the opposite side of my body.
Research Study Groups:
This trial has the following groups:- Group 1: ATTUNE Cementless RP TKA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT02839850 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare facilities are executing this experiment in real-world conditions?
"At present, 11 clinical trial sites are accepting participants. These locations are based in Newport News, Lubbock and DeLand as well as 8 other places. To avoid extensive travel commitments, it is recommended to pick the centre closest to you for enrollment purposes."
Answered by AI
Will participants be invited to join this investigation?
"Clinicaltrials.gov indicates that this research has stopped recruiting participants since November 28th 2022, which is when it was last updated. Nevertheless, there are 613 other trials currently accepting patients for enrollment."
Answered by AI
Does the research encompass individuals aged twenty or older?
"This research is restricted to those aged between 22 and 80. There are 30 clinical studies available for minors, while 583 trials target the elderly population."
Answered by AI
Am I able to participate in this medical investigation?
"For this clinical trial, 540 patients aged between 22 and 80 years old with arthrosis are being enrolled. To be included in the study, participants must possess basic literacy skills to comprehend the informed consent document and complete necessary patient reported outcomes (PROs). Furthermore, they must not be bedridden and agree to adhere to all investigational procedures. Lastly, those selected should meet diagnostic criteria for NIDJD as deemed suitable by their investigator for cementless primary TKA surgery involving resurfaced or non-resurfaced patellae."
Answered by AI
Who else is applying?
What state do they live in?
Texas
New York
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Florida Research Associates
SUNY downstate Medical Center
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Need help, not abel to walk. Looking at treatments for left knee. Right TKR is not great. Functions, have patella Baja clicking and pain around knee cap and back of knee.
PatientReceived 1 prior treatment
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