Evaluation of the Triathlon Hinge Knee System outcomes

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

This study is testing how well the Triathlon Hinge Knee System works for people getting knee surgeries, looking at their recovery and safety over time.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Locations: 2 sites (Weston, Florida and 1 other locations)
• Trial ID: NCT06379321 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the clinical outcomes of patients undergoing primary or revision knee surgeries using the Triathlon Hinge Knee System. It involves both prospective and retrospective data collection, focusing on patient demographics, surgical details, and functional outcomes over a period of up to 10 years. The study aims to assess the safety and performance of the device, determining factors that influence its survivorship and potential failure. Data collected will help develop a predictive model for better fixation outcomes in knee surgeries.

Who should consider this trial

Good fit: Ideal candidates include males or non-pregnant females undergoing primary or revision knee procedures with the Triathlon Hinge Knee System.

Not a fit: Patients with active infections, severe knee instability, or compromised bone stock may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the understanding of knee implant survivorship and enhance surgical outcomes for patients undergoing knee surgeries.

How similar studies have performed: Other studies evaluating similar knee systems have shown promising results, indicating that this approach is built on established methodologies.

Eligibility criteria

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

Where this trial is running

Weston, Florida and 1 other locations

• Cleveland Clinic Florida — Weston, Florida, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Nicolas Piuzzi, MD — Associate Staff Orthopaedic Surgery
• Study coordinator: Laura Stiegel

Conditions Knee Arthropathy; Recurrence; Knee Infection