No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
626 (estimated)
Sponsor
Canary Medical · Industry
Who this trial is looking for
This trial is looking for adults who are planning to have total knee replacement surgery due to severe knee pain from osteoarthritis. Participants will be monitored after their surgery to evaluate the treatment's safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years of age or older.
I qualify for total knee replacement surgery.
I have severe knee pain and disability from osteoarthritis.
I have mild or moderate knee deformities.
I can complete follow-up appointments.
I am a candidate for a 58mm or 30mm tibial stem extension.
I have a computer with internet access at home.
I can give my written consent to participate.
You may not be able to join if
I am having both knees replaced at the same time.
I had a knee replacement on the other knee within the last 6 months.
I currently abuse alcohol or drugs.
I am pregnant or breastfeeding.
I have a psychiatric condition that affects my ability to consent.
I have a history of joint infection.
I have osteoporosis or a serious condition affecting my limb.
I have a sensitivity to the materials used in the implant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The objectives of this prospective observational cohort study are to evaluate the safety, reliability, reproducibility, and accuracy of the Canary canturioTM te post-TKA.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion
* Patient must be 18 years of age or older
* Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to osteoarthritis, limited to:
* Mild or Moderate valgus, varus, or flexion deformities…
Inclusion
* Patient must be 18 years of age or older
* Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to osteoarthritis, limited to:
* Mild or Moderate valgus, varus, or flexion deformities
* Patient must be willing and able to complete the protocol required follow-up
* Patient is indicated for a 58mm or 30mm tibial stem extension
* Patient has participated in the study-related informed consent process
* Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved informed consent
* Patient has a platform-compatible personal computer located in their dwelling with appropriate wireless internet access and a USB port
* Independent of study participation, patient is a candidate for commercially available Persona Personalized Knee System implanted in accordance with product labeling
Exclusion
* Simultaneous bilateral TKA
* Staged bilateral TKA less than 6 months from indexed procedure
* Patient is a current alcohol or drug abuser
* Patient is known to be pregnant, breastfeeding, or considered a member of a protected class (e.g., prisoner, mentally incompetent, etc.)
* Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent and participation in follow-up program
* Patient has previous history of infection in the affected joint and/or a local or systemic infection that may affect the prosthetic joint
* Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
* Patient with skeletal immaturity
* Patient has insufficient bone stock on femoral or tibial surfaces
* Patient with Neuropathic Arthropathy
* Patient has osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb
* Patient has severe instability secondary to the absence of collateral ligament integrity.
* Patient has a stable, painless arthrodesis in a satisfactory functional position
* Patient has rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
* Patient has a known or suspected sensitivity to one or more of the implant materials
* Patient is undergoing procedures or treatments using ionizing radiation
* Patients with known symptomatic foot, hip, or spinal injuries and/or conditions that could affect gait
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