Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorThe Cleveland Clinic
About this trial
This study is a prospectively and retrospectively enrolled, post-market, open-label, non-randomized, single institution evaluation of clinical outcomes of primary or revision knee surgery patients who meet the eligibility criteria and received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).
Clinical evaluation for all cases will include data collection of patient demographics, surgical details, early postoperative status, functional and clinical outcomes, and survivorship at 1, 2, 6, and 10-years.
Eligibility criteria
Qualifiers
The subject undergoes a primary or revision procedure implanting at least the Revision Baseplate portion of the Triathlon Hinge Knee System in accordance with the Indications for Use.
The subject has signed an Institutional Review Board (IRB)/Ethical Committee (EC)-approved, study-specific Informed Consent Form (ICF).
The subject is a male or non-pregnant female at the time of enrollment.
The subject agrees to comply with the protocol-mandated clinical evaluations.
Disqualifiers
Any active or suspected latent infection in or about the knee joint; overt infection;
Distant foci of infection which may cause hematogenous spread to the implant site; rapid disease progression as manifested by joint destruction or bone resorption apparent on roentgenogram;
skeletally immature patients;
Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
Trial design
Treatments tested in this trial
- Triathlon Hinge Knee (THK) System
Treatment groups
200 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Locations
2Cleveland Clinic Florida33331, WestonFlorida, United States
Cleveland Clinic44195, ClevelandOhio, United States
Sponsors and collaborators
The Cleveland Clinic
Lead sponsor
Stryker Orthopaedics
Collaborator
Source ClinicalTrials.gov