Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System
A Retrospective/Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Hinge Knee (THK) System
The Cleveland Clinic
200 participants
May 10, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria15
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Participants receive Triathlon Hinge Knee (THK) System during primary or revision knee arthroplasty in accordance with the indications for use
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06379321