Actively Recruiting
Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System
Led by The Cleveland Clinic · Updated on 2026-03-02
200
Participants Needed
2
Research Sites
521 weeks
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
S
Stryker Orthopaedics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 of the Triathlon Hinge Knee System as per device indications
- Signed informed consent form approved by Institutional Review Board or Ethical Committee
- Male or non-pregnant female at enrollment
- Agree to follow all required clinical evaluations during the study
You will not qualify if you...
- Active or suspected infection in or around the knee joint
- Infection elsewhere that could spread to the implant site
- Rapid joint destruction or bone loss seen on X-rays
- Skeletally immature patients
- Severe knee instability due to loss of ligament function
- Bone condition or prior implants that do not support the prosthesis
- Known or suspected allergy to device materials
- Conditions increasing risk of implant failure, including uncooperative behavior, neurological disorders, osteoporosis, metabolic bone diseases, osteomalacia, or previous joint fusion
- Higher implant failure risk in paraplegia, cerebral palsy, or Parkinson's disease
- Any mental or neuromuscular disorder raising risk for implant problems or postoperative care issues
- Current prisoner status
AI-Screening
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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
CONTACT
S
Sanal Krishnan, PHD
CONTACT
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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