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Triathlon All-Polyethylene Tibia Outcomes Study

Sponsored by Stryker Orthopaedics

About this trial

Last updated 2 years ago

Study ID

104

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 4 years ago

What is this trial about?

The purpose of this study is to evaluate the clinical functional results of the Triathlon All-Polyethylene Tibia Knee Device.

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.

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Recruiting
Terminated