Evaluating the Triathlon All-Polyethylene Tibia Knee Device
A Retrospectively Enrolled and Prospectively Followed, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon All-Polyethylene Tibia
This study is testing how well the Triathlon All-Polyethylene Tibia Knee Device works for people who have had knee replacement surgery compared to a different type of knee device.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stryker Orthopaedics Industry-sponsored |
| Locations | 6 sites (Lansing, Michigan and 5 other locations) |
| Trial ID | NCT04636190 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical functional outcomes of the Triathlon All-Polyethylene Tibia Knee Device in patients who have undergone primary total knee arthroplasty (TKA). It involves a prospective evaluation of enrolled patients who will be followed for up to 10 years to assess their outcomes. A historical control group using a modular, metal-backed tibia and polyethylene insert will be utilized for comparison. The study aims to provide insights into the long-term effectiveness of this knee device.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have received the Triathlon All-Polyethylene Tibia and compatible Stryker components without any pending revisions.
Not a fit: Patients with active infections, those who are skeletally immature, or those with mental or neuromuscular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve knee replacement outcomes for patients with arthritis and other knee conditions.
How similar studies have performed: Other studies have shown promising results with similar knee replacement devices, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusions: * 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. * Patient has signed an IRB-approved, study specific Informed Patient Consent Form. * Patient is a male or non-pregnant female and is 18 years of age or older at the time of study device implantation. * Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations. Exclusions: * Patient had an active or suspected latent infection in or about the affected knee joint at time of study device implantation. * Patient had distant foci of infection which could have caused hematogenous spread to the implant site at time of study device implantation. * Patient was skeletally immature at time of study device implantation. * Patient has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. * Patient's bone stock was compromised by disease, infection, or prior implantation which cannot provide adequate support and/or fixation to the prosthesis. * Patient had severe instability of the knee joint secondary to the absence of collateral ligament integrity and function. * Patient was immunologically suppressed or receiving steroids in excess of normal physiological requirements at the time of surgery (e.g. \> 30 days). * Patient is a prisoner.
Where this trial is running
Lansing, Michigan and 5 other locations
- Michigan Orthopaedic Center — Lansing, Michigan, United States (Recruiting)
- Kaleida Health, Department of Orthopaedic Surgery, Buffalo General Hospital — Buffalo, New York, United States (Recruiting)
- Syracuse Orthopedic Specialists, PC — Syracuse, New York, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Terminated)
- Department of Orthopaedic Surgery Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Musculoskeletal Institute, University of Texas Health Austin — Austin, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Marissa Puccio
- Email: marissa.puccio@stryker.com
- Phone: 201-675-1416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.