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

Launched by THE CLEVELAND CLINIC · Apr 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the outcomes of a special knee device called the Triathlon Hinge Knee System, which is used for patients undergoing knee surgery, either for the first time or as a follow-up to a previous surgery. The main goal is to see how well this device works over time, specifically in helping patients recover from knee problems, including arthritis or infections. The study will gather information about patients’ backgrounds, details about their surgeries, and their recovery progress at different stages, including 1, 2, 6, and 10 years after the surgery.

To take part in this study, participants need to be adults who are having surgery that includes the Triathlon Hinge Knee device, and they must agree to follow the study's guidelines. However, individuals with certain conditions, like active infections in the knee or severe instability, cannot join. If you or someone you know is considering this surgery and meets the eligibility criteria, you can expect close monitoring of your recovery and the chance to contribute to important research that may help improve knee treatments in the future.

Gender

ALL

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 IRB/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