Recruiting

THK System

Sponsor:

The Cleveland Clinic

Code:

NCT06379321

Conditions

Knee Arthropathy

Recurrence

Knee Infection

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Triathlon Hinge Knee (THK) System

Study Details

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

Study ID

NCT06379321

Start date

May 10, 2024

Status verified date

Feb, 2026

Completion date

May 10, 2034

Anticipated

Primary completion date

May 10, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Primary

Triathlon Hinge Femoral Component + Revision Baseplate

Revision

Triathlon Hinge Femoral Component+ Revision Baseplate

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

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

Participants receive Triathlon Hinge Knee (THK) System during primary or revision knee arthroplasty in accordance with the indications for use

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Laura Stiegel

216-442-5511stiegel@ccf.org

Sanal Krishnan, PHD

216-445-7194krishns11@ccf.org

Locations

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Contacts

Kaitlin Bernabe

954-610-8016BERNABK@ccf.org

Principal Investigator:

Jorge Manrique-Succar

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Laura Stiegel

216-442-5511stiegel@ccf.org

Sanal Krishnan

216-445-7194krishns11@ccf.org

Principal Investigator:

Matthew Deren, M.D.

More Information

Sponsor

The Cleveland Clinic

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-03-02.