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Recruiting NCT06379321

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

— Observational Knee Arthropathy Recurrence Knee Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Triathlon Hinge Knee (THK) System.
Who it may be relevant to
Registry conditions: Knee Arthropathy, Recurrence, Knee Infection. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Retrospective/Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Hinge Knee (THK) System

Overview

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.

Detailed description

The purpose of this study is to evaluate the safety and performance of the Triathlon Hinge Knee System for both primary and revision cases in accordance with the Indications for Use.

The main objective of this study is to determine (1) mid- (5 year) and long-term (10 year) survivorship, and (2) drivers of failure for the Triathlon Hinge Knee (THK) hinge. Data from this study will be used to develop a predictive model to identify the most important factors in achieving fixation, including the role of augments, cones, thresholds for cement mantle thickness, and number of zones of fixation required for survivorship.

Survivorship is defined as the absence of aseptic revision to the implanted device.

The Triathlon Hinge Knee System consists of Triathlon Hinge femoral components, the Triathlon Revision baseplate, Triathlon Revision Tibial Augments, Triathlon Hinge Femoral Distal Augments, Triathlon Hinge Insert, Triathlon Revision Insert X3, and Triathlon Hinge Bumpers, Axle, Bushings, Tibial Sleeve, and Bearing component.

It is designed to be a single platform for revision, difficult primary, and limb salvage surgeries.

Interventions

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

Primary outcome measures

  • Survivorship [Time frame: 1, 2, 6 and 10 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
  • Known or suspected sensitivity and/or allergy to any material in the device.
  • Conditions presenting an increased risk of failure include:
  • uncooperative patient or patient with neurologic disorder, incapable of following instructions;
  • osteoporosis;
  • metabolic disorders which may impair bone formation or cause bone loss;
  • osteomalacia; and,
  • previous arthrodesis.
  • A higher incidence of implant failure has also occurred in paraplegics, cerebral palsy and patients with Parkinson's disease.
  • Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
  • The subject is a prisoner

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Cleveland Clinic Florida — Weston
  • Cleveland Clinic — Cleveland

Identifiers

NCT: NCT06379321 · 24-362

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗