Actively Recruiting
A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System
Led by Exactech · Updated on 2024-06-18
1000
Participants Needed
5
Research Sites
861 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Post-Market Domestic (US) and International Data Collection to Assess the Truliant® Knee System
CONDITIONS
Official Title
A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must be 18 years or older and skeletally mature.
- Subjects must agree to participate and provide written informed consent.
- Subjects will receive or have received a Truliant4 total knee replacement for specified conditions including osteoarthritis, avascular necrosis, rheumatoid arthritis, post-traumatic arthritis, polyarthritis, primary implantation failure, or conversion of uni-compartmental knee.
- The knee replacement surgery must be performed by the investigator or a surgeon sub-investigator.
- Devices must be used according to approved indications.
- For retrospective subjects, medical records must include detailed pre-operative, operative, and post-operative data related to the Truliant knee prosthesis.
- Patients enrolled pre-surgery must not have had prior surgery before enrollment.
- Patients enrolled post-surgery must have completed surgery prior to enrollment and meet all study criteria.
You will not qualify if you...
- Patients younger than 18 years at time of surgery.
- Patients who do not meet the indicated population criteria for device use.
- Pregnant patients.
- Prisoners.
- Patients with physical or mental conditions that would invalidate study results.
- Patients contraindicated for surgery, such as those with metal allergies.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Colorado Health
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Florida Research Associates
DeLand, Florida, United States, 32720
Actively Recruiting
3
Nevada Orthopaedic and Spine Center
Las Vegas, Nevada, United States, 89128
Actively Recruiting
4
Crystal Clinic
Akron, Ohio, United States, 44333
Actively Recruiting
5
Medical University South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
P
Pearl Harris
CONTACT
A
Alex Knisely
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
3
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