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

NCT06379321 | Recruiting FDA Device

• 1 other identifier: 24-362
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

Primary

Triathlon Hinge Femoral Component + Revision Baseplate

Device: Triathlon Hinge Knee (THK) System

Revision

Triathlon Hinge Femoral Component+ Revision Baseplate

Device: Triathlon Hinge Knee (THK) System

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

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

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

Primary; Revision; Revision (Maximum of 80 subjects)

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Stryker Orthopaedics: collaborator

Study Sites (2)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Recurrence

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Nicolas Piuzzi, MD

  Associate Staff Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Stiegel

CONTACT

216-442-5511; stiegel@ccf.org

Sanal Krishnan, PHD

CONTACT

216-445-7194; krishns11@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: May 10, 2024
• Primary Completion (Estimated): May 10, 2034
• Study Completion (Estimated): May 10, 2034
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)