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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06379321
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The Cleveland Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Matthew Deren, M.D.
Principal Investigator Affiliation	The Cleveland Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Knee Arthropathy, Recurrence, Knee Infection

Additional Details

The purpose of this study is to evaluate the safety and performance of the Triathlon Hinge Knee System for both primary and revision cases in accordance with the Indications for Use. The main objective of this study is to determine

(1) mid- (5 year) and long-term (10 year) survivorship, and (2) drivers of failure for the THK hinge.

Data from this study will be used to develop a predictive model to identify the most important factors in achieving fixation, including the role of augments, cones, thresholds for cement mantle thickness, and number of zones of fixation required for survivorship. Survivorship is defined as the absence of aseptic revision to the implanted device. The Triathlon Hinge Knee System consists of Triathlon Hinge femoral components, the Triathlon Revision baseplate, Triathlon Revision Tibial Augments, Triathlon Hinge Femoral Distal Augments, Triathlon Hinge Insert, Triathlon Revision Insert X3, and Triathlon Hinge Bumpers, Axle, Bushings, Tibial Sleeve, and Bearing component. It is designed to be a single platform for revision, difficult primary, and limb salvage surgeries.

Arms & Interventions

Arms

: Primary

Triathlon Hinge Femoral Component + Revision Baseplate

: Revision

Triathlon Hinge Femoral Component+ Revision Baseplate

: TS Revision

Triathlon TS Femoral Component+ Revision Baseplate

: Revision (Maximum of 80 subjects)

Triathlon TS Femoral Component + Revision Baseplate

: MRH Revision

MRH Femoral Component + Revision Baseplate

: GMRS Primary or Revision

GMRS Femoral Component + Revision Baseplate

Interventions

Device: - 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland Clinic Florida, Weston, Florida

Status

Recruiting

Address

Cleveland Clinic Florida

Weston, Florida, 33331

Site Contact

Kaitlin Bernabe

[email protected]

954-610-8016

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Laura Stiegel

[email protected]

216-442-5511

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