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Orthopedic Implant
Artificial Knee Joint for Knee Replacement
N/A
Waitlist Available
Research Sponsored by Stryker Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is a male or non-pregnant female, skeletally mature and age 18 years or older at time of study device implantation
Patient is a candidate for revision of all femoral and tibial components of a total knee replacement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of a new type of artificial knee joint. The revision rate of the new artificial knee joint is expected to be less than 2.8% at 2 years postoperative.
Who is the study for?
This trial is for adults over 18 needing revision knee replacement surgery, who can follow the post-op plan. It's not for those with a BMI over 45, infections around the knee, systemic diseases like Lupus, excessive steroid use, prisoners, material allergies or certain neuromuscular issues.Check my eligibility
What is being tested?
The study evaluates Triathlon Tritanium Cone Augments in knee revision surgeries. It aims to show that less than 2.8% of these augments will loosen within two years after surgery without randomizing patients into different treatment groups.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks of knee revision surgery may include pain at the site, infection risk increase and possible complications related to implant loosening.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18, not pregnant, and my bones have stopped growing.
Select...
I am eligible for a complete knee replacement revision.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of cases with revision of the Femoral Cone Augment or Tibial Cone Augment for aseptic loosening
Secondary outcome measures
Anderson Orthopaedic Research Institute (AORI) classification and Femoral Cone Augment size.
Anderson Orthopaedic Research Institute (AORI) classification and Tibial Asymmetric Cone Augment size.
Bone structure of tibia
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Triathlon Tritanium Cone AugmentsExperimental Treatment1 Intervention
Cases who receive the Triathlon TS Total Knee System with at least one Triathlon Tritanium Cone Augment
Find a Location
Who is running the clinical trial?
Stryker OrthopaedicsLead Sponsor
77 Previous Clinical Trials
20,088 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition like Lupus or Paget's disease that worsens my bone health.I am on long-term steroids or have a weakened immune system.I am over 18, not pregnant, and my bones have stopped growing.I am eligible for a complete knee replacement revision.I am willing and able to follow through with all after-surgery check-ups and rehab.I am eligible for a complete redo of my knee replacement surgery.I am willing and able to follow through with all after-surgery check-ups and rehab.I am an adult over 18, not pregnant, and my bones have stopped growing.I might have an infection in or near my knee where a device will be implanted.
Research Study Groups:
This trial has the following groups:- Group 1: Triathlon Tritanium Cone Augments
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 large is the cohort currently enrolled in this research?
"This research demands 145 eligible individuals to participate. Participants can enroll from Rothman Institute in Egg Harbor Township, New jersey and Providence Medical Research Center in Spokane, Washington plus other specified sites."
Answered by AI
Is there currently an open call for participants in this investigation?
"Affirmative. According to the clinical trial data hosted on clinicialtrials.gov, this experiment is still looking for volunteers; it was initially posted in 2015 and most recently updated in 2022. To complete this study, 145 patients need to be enrolled from 9 sites around the country."
Answered by AI
Are there multiple centers within the state offering this trial?
"Nine clinical trial sites are inviting patients to join the medical study, these include Rothman Institute in Egg Harbor Township, Providence Medical Research Center in Spokane and The CORE Institute in Novi. Additionally there are multiple other recruitment centres scattered around the USA."
Answered by AI
Who else is applying?
What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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