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Orthopedic Implant
Triathlon Knee Replacement for Knee Arthritis (APT Trial)
N/A
Recruiting
Research Sponsored by Stryker Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient underwent primary TKA and is currently implanted with the Triathlon All-Polyethylene Tibia as well as compatible Stryker femoral and patellar components with no pending revision or removal.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10-years postoperative
Awards & highlights
APT Trial Summary
This trial will study how well the Triathlon All-Polyethylene Tibia Knee Device works in patients with osteoarthritis.
Who is the study for?
This trial is for adults over 18 who have had a primary total knee replacement using the Triathlon All-Polyethylene Tibia and compatible components, without plans for revision. Participants must be able to follow up with clinical evaluations. Those with infections, compromised bone stock, mental or neuromuscular disorders, excessive steroid use, or are prisoners cannot join.Check my eligibility
What is being tested?
The study aims to assess the functional outcomes of patients who received the Triathlon All-Polyethylene Tibia Knee Device during knee replacement surgery. It will involve scheduled clinical and radiographic evaluations post-surgery.See study design
What are the potential side effects?
While specific side effects are not listed for this device study, typical risks may include pain at the implant site, swelling, infection risk around the knee joint area, and potential issues with prosthesis stability.
APT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a Triathlon knee implant with no plans for changes.
APT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10-years postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10-years postoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Knee Society Score (KSS) Function
Secondary outcome measures
Kaplan-Meier Survival Analysis
APT Trial Design
1Treatment groups
Experimental Treatment
Group I: Triathlon All-Polyethylene Tibia KneeExperimental Treatment1 Intervention
All subjects enrolled will have received the Triathlon All-Polyethylene Tibia Knee device.
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Who is running the clinical trial?
Stryker OrthopaedicsLead Sponsor
77 Previous Clinical Trials
20,029 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My knee is very unstable because of damaged ligaments.I have a Triathlon knee implant with no plans for changes.I was on high-dose steroids or had a weakened immune system during my surgery.I was still growing when I received my implant.I had an infection that could spread through the blood to where my device was implanted.You have a mental or muscle disorder that could make it too risky to have a prosthetic device implanted, or could cause problems during recovery after surgery.I am willing and able to follow up with all required post-surgery check-ups and scans.I am 18 or older and not pregnant.I had an infection in my knee when the device was implanted.My bones are too weak to support or attach to a medical implant due to disease, infection, or previous surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Triathlon All-Polyethylene Tibia Knee
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are presently taking part in this clinical trial?
"Afirmative. According to the records posted on clinicaltrials.gov, this experiment is still open for enrollment and was first made public on July 2nd 2021. As of now, it requires a total of 204 test subjects at 5 different locations."
Answered by AI
Does this research endeavor currently accept new participants?
"Affirmative. Data available on clinicaltrials.gov demonstrate that this research is actively searching for participants; the trial was initially posted on July 2nd 2021 and last updated on July 8th 2022. Thus far, 204 individuals have been recruited from five separate sites."
Answered by AI
Across how many distinct sites is this clinical investigation being managed?
"Various orthopaedic departments around the United States are currently operating this clinical trial. These include Cleveland Clinic in Cleveland, Kaleida Health and Buffalo General Hospital in Buffalo, as well as Duke University Medical Center in Durham."
Answered by AI
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