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Triathlon All-Polyethylene Tibia Outcomes Study

A Retrospectively Enrolled and Prospectively Followed, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon All-Polyethylene Tibia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04636190
Acronym
APT
Enrollment
204
Registered
2020-11-19
Start date
2021-07-02
Completion date
2033-10-01
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Knee, Knee Arthritis, Replacement

Brief summary

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

Detailed 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.

Interventions

DEVICETriathlon All-Polyethylene Tibia Knee

Triathlon All-Polyethylene Tibia Knee is an all polyethylene resurfacing knee device using either a condylar stabilizing (CS) and posterior stabilizing (PS) device.

Sponsors

Stryker Orthopaedics
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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 duration of treatment). * Patient is a prisoner.

Design outcomes

Primary

MeasureTime frameDescription
Knee Society Score (KSS) Function10-years postoperativeThe Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome postoperative.

Secondary

MeasureTime frameDescription
Kaplan-Meier Survival Analysis10-years postoperativeTo present 10-year Kaplan-Meier survival analysis for the Triathlon APT

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026