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

Part of paid clinical trials in Weston, Florida.

Sponsor
The Cleveland Clinic
Study ID
NCT06379321
Status
Recruiting
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Conditions

  • Knee Arthropathy
  • Knee Infection
  • Recurrence

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
May 10, 2024
Status verified
Feb 2026
Primary completion
May 10, 2034
Completion
May 10, 2034

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Primary
    Triathlon Hinge Femoral Component + Revision Baseplate
  • Arm: Revision
    Triathlon Hinge Femoral Component+ Revision Baseplate
  • Arm: Total Stabilized (TS) Revision
    Triathlon Total Stabilized (TS) Femoral Component+ Revision Baseplate
  • Arm: Revision (Maximum of 80 subjects)
    Triathlon Total Stabilized (TS) Femoral Component + Revision Baseplate
  • Arm: Modular Rotating Hinge (MRH) Revision
    Modular Rotating Hinge (MRH) Femoral Component + Revision Baseplate
  • Arm: Global Modular Replacement System (GMRS) Primary or Revision
    Global Modular Replacement System (GMRS) Femoral Component + Revision Baseplate

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FloridaWestonFlorida33331
Kaitlin Bernabe
[email protected]
954-610-8016
Jorge Manrique-Succar (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Laura Stiegel
[email protected]
216-442-5511
Sanal Krishnan
[email protected]
216-445-7194
Matthew Deren, M.D. (PRINCIPAL_INVESTIGATOR)

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