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Prosthesis
Total Knee Replacement for Osteoarthritis
N/A
Waitlist Available
Research Sponsored by DePuy International
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is male or female and between the ages of 22 and 75 years at the time of surgery, inclusive
Subject is a suitable candidate for cemented primary total knee arthroplasty using the devices described in this protocol with either resurfaced or non-resurfaced patellae
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum 15 years (5414 - 5658 days)
Awards & highlights
Study Summary
This trial will evaluate the long-term survivorship of a knee prosthesis in patients with non-inflammatory degenerative joint disease.
Who is the study for?
This trial is for adults aged 22-75 with non-inflammatory degenerative joint disease needing knee replacement. Candidates must be able to follow the study procedures, not bedridden, and not have conditions like fibromyalgia under treatment or disorders affecting gait. Pregnant women and those in other trials recently are excluded.Check my eligibility
What is being tested?
The Attune Primary Total Knee Replacement's long-term effectiveness (up to 15 years) is being tested on patients with arthritis-related knee issues. The study pools data from four different knee configurations to create a comprehensive dataset.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks of total knee replacement may include pain, swelling, infection risk at the surgery site, blood clots, and potential complications leading to further surgeries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 22 and 75 years old.
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I am a good candidate for a specific knee replacement surgery as described.
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I am not confined to bed.
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I am between 22 and 75 years old.
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I have been diagnosed with a non-inflammatory joint disease.
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I am not confined to bed.
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I am a good candidate for a specific knee replacement surgery as described.
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I have been diagnosed with a non-inflammatory joint disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ minimum 15 years (5414 - 5658 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minimum 15 years (5414 - 5658 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Survivorship of each configuration.
Secondary outcome measures
Evaluate changes in femoral component and tibial component alignment
Evaluate the impact of surgeon learning curve on clinical and functional outcomes
Implant fixation: Radiographic assessment of bone-implant interface performance
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Attune Primary Total Knee ReplacementExperimental Treatment1 Intervention
Subjects will receive one of the following Attune total knee implants:
Cruciate retaining fixed bearing (CR FB) Cruciate retaining rotating platform (CR RP) Posterior stabilized fixed bearing (PS FB) Posterior stabilized rotating platform (PS RP)
Find a Location
Who is running the clinical trial?
DePuy InternationalLead Sponsor
58 Previous Clinical Trials
10,841 Total Patients Enrolled
40 Trials studying Osteoarthritis
7,038 Patients Enrolled for Osteoarthritis
Allyson MorrisStudy DirectorDePuy Synthes
1 Previous Clinical Trials
34 Total Patients Enrolled
1 Trials studying Osteoarthritis
34 Patients Enrolled for Osteoarthritis
Kirstin CosgroveStudy DirectorDePuy Synthes
1 Previous Clinical Trials
81 Total Patients Enrolled
1 Trials studying Osteoarthritis
81 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery on my knee before, like a partial replacement or other specific procedures.I am currently taking medication for my diagnosed fibromyalgia.I have a condition like MS that affects my walking or ability to support my weight.I am not comfortable with the languages available for the study's patient-reported outcomes.I am between 22 and 75 years old.I can speak, read, and understand one of the languages available for the study.I understand the study and can follow all procedures and visits.I am currently pregnant or breastfeeding.I have had an amputation on the opposite side of my body.I am experiencing pain that spreads from my spine.I am a good candidate for a specific knee replacement surgery as described.I am not confined to bed.I am between 22 and 75 years old.I have been diagnosed with a non-inflammatory joint disease.I understand the study and can follow all procedures and visits.I am not confined to bed.I am a good candidate for a specific knee replacement surgery as described.I can speak, read, and understand one of the languages available for the study.I have been diagnosed with a non-inflammatory joint disease.I have a type of inflammatory arthritis like rheumatoid or psoriatic arthritis.
Research Study Groups:
This trial has the following groups:- Group 1: Attune Primary Total Knee Replacement
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: NCT01754363 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there multiple venues in the United States conducting this research project?
"This medical trial can be accessed at 17 different sites, including Orange, Saint Louis and Louisville. To minimise transit expenses, it is crucial to select the closest clinic when enrolling in this research project."
Answered by AI
Does the study encompass individuals over sixty years of age?
"Eligibility criteria for this clinical trial require that participants are between the ages of 22 and 75."
Answered by AI
Who would be the ideal candidate to participate in this experiment?
"This clinical trial is searching for 1542 participants suffering from joint disorders, aged between 22 and 75 years old. To qualify, contenders must have the capacity to converse fluently in an applicable translated language including reading and understanding instructions provided by PROs in this protocol; they should also be able-bodied enough to undergo surgical procedures such as primary total knee arthroplasty using the devices described within it with either resurfaced or non-resurfaced patellae while actively engaging with all study processes and follow up visits according to their Clinical Investigator's opinion."
Answered by AI
Are there opportunities for participants to enlist in this experiment?
"According to the clinicaltrials.gov website, this trial is no longer enrolling participants; its initial posting was on 2/1/2013 and it has seen a recent update of 11/28/2022. Nonetheless, there are 706 other trials in progress that require patients to participate."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Mayo Clinic Arizona
Florida Research Associates, LLC
Cardinal Orthopaedic Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Had right knee replaced. Its ok, but clicks and swells around knee cap. Looking at other options for left knee.
PatientReceived no prior treatments
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