Triathlon All-Polyethylene Tibia Outcomes Study
Sponsored by Stryker Orthopaedics
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 4 years ago
What is this trial about?
What are the Participation Requirements?
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.