RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-05-10
Study Completion:2034-05-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06379321

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * The subject has signed an IRB/EC-approved, study-specific Informed Consent Form (ICF).
  3. * The subject is a male or non-pregnant female at the time of enrollment.
  4. * The subject agrees to comply with the protocol-mandated clinical evaluations.
  1. * Any active or suspected latent infection in or about the knee joint; overt infection;
  2. * 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;
  3. * skeletally immature patients;
  4. * Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
  5. * Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
  6. * Known or suspected sensitivity and/or allergy to any material in the device.
  7. * Conditions presenting an increased risk of failure include:
  8. * uncooperative patient or patient with neurologic disorder, incapable of following instructions;
  9. * osteoporosis;
  10. * metabolic disorders which may impair bone formation or cause bone loss;
  11. * osteomalacia; and,
  12. * previous arthrodesis.
  13. * A higher incidence of implant failure has also occurred in paraplegics, cerebral palsy and patients with Parkinson's disease.
  14. * Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
  15. * The subject is a prisoner

Contacts and Locations

Study Contact

Laura Stiegel
CONTACT
216-442-5511
stiegel@ccf.org
Alison Klika, M.S.
CONTACT
216 444-4954
klikaa@ccf.org

Principal Investigator

Matthew Deren, M.D.
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Florida
Weston, Florida, 33331
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-10
Study Completion Date2034-05-10

Study Record Updates

Study Start Date2024-05-10
Study Completion Date2034-05-10

Terms related to this study

Additional Relevant MeSH Terms

  • Knee Arthropathy
  • Recurrence
  • Knee Infection