Triathlon All-Polyethylene Tibia Outcomes Study (APT)

Stryker

Status

Active, not recruiting

Conditions

Knee Arthritis

Replacement

Arthropathy of Knee

Treatments

Device: Triathlon All-Polyethylene Tibia Knee

Study type

Interventional

Funder types

Industry

Identifiers

NCT04636190

104

Details and patient eligibility

About

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

Full description

This study is a retrospectively enrolled, prospective evaluation of the Triathlon All-Polyethylene Tibia (APT) for patients who meet the eligibility criteria. The enrolled cases will be followed for outcomes measured to 10 years. A modular, Triathlon metal-backed tibia (MBT) and polyethylene insert construct will be used as a historical control.

Enrollment

204 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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.