CR17-003 Truliant Knee PMCF: A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System
Exactech
Summary
A Post-Market Domestic (US) and International Data Collection to Assess the Truliant® Knee System
Description
Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive a Truliant® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Cohort 1. Prospective / Subjects- Enrolled in the study pre-surgery 1. Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study. 2. Skeletally mature (18 years of age or older). 3. Subject is willing and able to provide written informed consent for participation in the study. 4. Subject is to receive a Truliant® total knee replacement for Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Polyarthritis, Primary Implantation Failure, or as a Conversion of Uni-Compartmental Knee. 5. The kn…
Interventions
- DeviceTruliant Total Knee System
Total Knee Arthroplasty using Exactech's Truliant® branded components are compatible with Optetrak branded components.
Locations (5)
- University of Colorado HealthAurora, Colorado
- Florida Research AssociatesDeLand, Florida
- Nevada Orthopaedic and Spine CenterLas Vegas, Nevada
- Crystal ClinicAkron, Ohio
- Medical University South CarolinaCharleston, South Carolina