Actively Recruiting
Evaluation of Clinical Outcomes of the Triathlon Hinge Knee System in Primary and Revision Knee Surgery A Retrospective/Prospective Post-market Multi-center Study
Led by The Cleveland Clinic · Updated on 2026-03-02
200
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
S
Stryker Orthopaedics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical outcomes of patients undergoing primary or revision knee surgery using the Triathlon Hinge Knee System. This post-market, open-label study includes both prospectively and retrospectively enrolled patients who meet the eligibility criteria. The study aims to assess mid- and long-term survivorship of the device and identify key factors contributing to its success or failure. Survivorship is defined as the absence of aseptic revision to the implanted device. Participants receive the Triathlon Hinge Knee System components during their knee arthroplasty procedures. The system includes various femoral components, revision baseplates, tibial augments, inserts, bumpers, axles, bushings, tibial sleeves, and bearing components. The device is intended for use in revision, difficult primary, and limb salvage surgeries. The study evaluates different device configurations, including Modular Rotating Hinge and Global Modular Replacement System components. Throughout the study, data will be collected on patient demographics, surgical details, early postoperative status, and functional and clinical outcomes. Survivorship will be monitored at 1, 2, 6, and 10 years after surgery. Participants will undergo protocol-mandated clinical evaluations to assess safety and performance. The study is conducted by The Cleveland Clinic and aims to develop predictive models for successful implant fixation.
CONDITIONS
Brief Title
Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing primary or revision knee surgery implanting at least the Revision Baseplate portion of the Triathlon Hinge Knee System
- Signed informed consent approved by an Institutional Review Board or Ethics Committee
- Male or non-pregnant female at enrollment
- Willing to comply with protocol-required clinical evaluations
You will not qualify if you...
- Active or suspected infection in or around the knee joint
- Distant infections that may spread to the implant site
- Rapid joint destruction or bone loss seen on x-rays
- Skeletally immature patients
- Severe knee instability due to lack of collateral ligament function
- Bone damage preventing proper support or fixation of the implant
- Known or suspected allergy to device materials
- Increased failure risk from uncooperative behavior, neurological disorders, osteoporosis, metabolic bone diseases, osteomalacia, or previous joint fusion
- Mental or neuromuscular disorders posing risk to implant stability or post-op care
- Prisoners
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive the Triathlon Hinge Knee (THK) System during primary or revision knee surgery in accordance with the indications for use.
1 visit (in-person) on the day of surgery
Duration - Up to 10 years
Participants are monitored to evaluate the mid- (5 year) and long-term (10 year) survivorship and identify factors influencing implant success.
Follow-up visits at 1, 2, 6, and 10 years post-implantation
Trial Site Locations
Total: 2 locations
1
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Actively Recruiting
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
L
Laura Stiegel
S
Sanal Krishnan, PHD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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