Clinical trial NCT04636190: Triathlon All-Polyethylene Tibia Outcomes Study
Official title: A Retrospectively Enrolled and Prospectively Followed, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon All-Polyethylene Tibia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthropathy of Knee
Replacement
Knee Arthritis
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Knee Society Score (KSS) Function
timeFrame: 10-years postoperative
Secondary outcomes:
measure: Kaplan-Meier Survival Analysis
timeFrame: 10-years postoperative
Other outcomes:
Locations:
city: Lansing
country: United States
facility: Michigan Orthopaedic Center
state: Michigan
city: Buffalo
country: United States
facility: Kaleida Health, Department of Orthopaedic Surgery, Buffalo General Hospital
state: New York
city: Syracuse
country: United States
facility: Syracuse Orthopedic Specialists, PC
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Department of Orthopaedic Surgery Cleveland Clinic
state: Ohio
city: Austin
country: United States
facility: Musculoskeletal Institute, University of Texas Health Austin
state: Texas
Study officials:
References: