Triathlon All-Polyethylene Tibia Outcomes Study

Launched by STRYKER ORTHOPAEDICS · Nov 13, 2020

Keywords

ClinConnect Summary

The Triathlon All-Polyethylene Tibia Outcomes Study is looking at how well a specific knee implant, called the Triathlon All-Polyethylene Tibia, works for people who have had knee replacement surgery. This study aims to understand the results of using this device in patients who have undergone a total knee arthroplasty (TKA) and are currently using compatible components from the same brand. The study is open to all adults aged 18 and older, but participants must be in good health without any active infections or other serious medical conditions that could affect their recovery.

If you decide to participate, you will need to agree to follow up with your doctor for scheduled check-ups and imaging tests after your surgery. This is important to ensure your knee is healing properly and the implant is functioning as it should. The study is currently recruiting new participants, and it's an opportunity to help researchers learn more about knee replacements and improve future treatments for patients with knee arthritis.

Gender

ALL

Eligibility 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.