Health TrialsbyHealthPanel

Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System

ConditionsKnee ArthropathyRecurrenceKnee Infection
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

This trial does not accept healthy volunteers

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 population

Participants who meet the eligibility criteria and receive/received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Triathlon Hinge Knee (THK) System

    Device

    Participants receive Triathlon Hinge Knee (THK) System during primary or revision knee arthroplasty in accordance with the indications for use

Treatment groups

200 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Primary1 intervention
Group B: Revision1 intervention
Group C: Total Stabilized (TS) Revision0 interventions
Group D: Revision (Maximum of 80 subjects)1 intervention
Group E: Modular Rotating Hinge (MRH) Revision0 interventions
Group F: Global Modular Replacement System (GMRS) Primary or Revision0 interventions

Trial outcomes

Primary outcomes

1

Survivorship

To evaluate the survivorship of the Hinge Knee System at postoperatively. Survival is defined as the absence of aseptic revision to the implanted device.

Time frame
1, 2, 6 and 10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

Stryker Orthopaedics

Collaborator

Source ClinicalTrials.gov
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