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Procedure
Attune Cementless Knee Replacement for Osteoarthritis
N/A
Recruiting
Led By Thomas Turgeon, MD
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
Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
Patients aged 21 years or older
Must not have
Posterior cruciate ligament (PCL) deficiency
Conditions that are cautioned against or contraindicated, as listed in the product monograph and/or instruction for use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 months, 1-2 years post-operative
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying patients who are having knee surgery using a specific type of knee replacement system called Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System. The trial is being conducted
Who is the study for?
This trial is for individuals with osteoarthritis who are candidates for total knee replacement surgery. Specific eligibility criteria to participate in the study have not been provided, so interested patients should contact the study organizers for more information.
What is being tested?
The trial is evaluating a specific type of knee replacement called the Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System. It's being tested at multiple centers and involves patients receiving this particular implant during their surgery.
What are the potential side effects?
Potential side effects are not detailed here but may include typical risks associated with knee replacement surgeries such as pain, swelling, infection risk at the surgical site, blood clots, or issues related to how well the implant fixes to bone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need a knee replacement due to severe arthritis pain.
Select...
I am 21 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My posterior cruciate ligament is damaged.
Select...
I have no health conditions that the treatment's guide says should avoid it.
Select...
I have a type of joint inflammation.
Select...
I cannot undergo major surgery due to my health condition.
Select...
I need surgery for bone defects using specific implants.
Select...
I have had an infection in the same limb as my current condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-12 months, 1-2 years post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 months, 1-2 years post-operative
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Tibial baseplate stability
Secondary study objectives
Equivalency between CT-RSA-measured migration and the gold-standard of RSA-measured migration
European Quality of Life (EQ-5D-5L)
Femoral component migration
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Attune Cementless, Fixed Bearing, Cruciate Retaining TKA SystemExperimental Treatment1 Intervention
Attune Cruciate Retaining TKA System
Find a Location
Who is running the clinical trial?
Canadian Radiostereometric Analysis NetworkLead Sponsor
8 Previous Clinical Trials
390 Total Patients Enrolled
4 Trials studying Osteoarthritis
158 Patients Enrolled for Osteoarthritis
Thomas Turgeon, MDPrincipal InvestigatorConcordia Hospital
8 Previous Clinical Trials
351 Total Patients Enrolled
1 Trials studying Osteoarthritis
11 Patients Enrolled for Osteoarthritis
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