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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrence; Knee Arthropathy; Knee Infection
• Intervention / Treatment: Device: Triathlon Hinge Knee (THK) System

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Laura Stiegel; Phone Number: 216-442-5511; Email: stiegel@ccf.org
• Study Contact Backup: Name: Sanal Krishnan, PHD; Phone Number: 216-445-7194; Email: krishns11@ccf.org

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Recruiting
      • Cleveland Clinic Florida
      • Contact: Kaitlin Bernabe; Phone Number: 954-610-8016; Email: BERNABK@ccf.org
      • Principal Investigator: Jorge Manrique-Succar
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Laura Stiegel; Phone Number: 216-442-5511; Email: stiegel@ccf.org
      • Principal Investigator: Matthew Deren, M.D.
      • Contact: Sanal Krishnan; Phone Number: 216-445-7194; Email: krishns11@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Participants who meet the eligibility criteria and receive/received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary; Triathlon Hinge Femoral Component + Revision Baseplate	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
Revision; Triathlon Hinge Femoral Component+ Revision Baseplate	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
Total Stabilized (TS) Revision; Triathlon Total Stabilized (TS) Femoral Component+ Revision Baseplate
Revision (Maximum of 80 subjects); Triathlon Total Stabilized (TS) Femoral Component + Revision Baseplate	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
Modular Rotating Hinge (MRH) Revision; Modular Rotating Hinge (MRH) Femoral Component + Revision Baseplate
Global Modular Replacement System (GMRS) Primary or Revision; Global Modular Replacement System (GMRS) Femoral Component + Revision Baseplate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship	To evaluate the survivorship of the Hinge Knee System at postoperatively. Survival is defined as the absence of aseptic revision to the implanted device.	1, 2, 6 and 10 years

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Stryker Orthopaedics
• Investigators: Principal Investigator: Nicolas Piuzzi, MD, Associate Staff Orthopaedic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Estimated): May 10, 2034
• Study Completion (Estimated): May 10, 2034

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Recurrence; Therapeutics; Drug Therapy; Drug Delivery Systems
• Other Study ID Numbers: 24-362

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No