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

Description

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.

Conditions

Knee Arthropathy, Recurrence, Knee Infection

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Study Overview

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Study Details

Study 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.

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

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

Condition
Knee Arthropathy
Intervention / Treatment

-

Contacts and Locations

Weston

Cleveland Clinic Florida, Weston, Florida, United States, 33331

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 IRB/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.
  • * 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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Matthew Deren, M.D., PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2034-05-10