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

NCT06379321 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-03-02

No results posted yet for this study

Summary

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

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

Sponsors & Collaborators

  • Stryker Orthopaedics

    collaborator INDUSTRY

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Nicolas Piuzzi, MD · Associate Staff Orthopaedic Surgery

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2034-05-10
Completion
2034-05-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06379321 on ClinicalTrials.gov