Long-term results of total knee arthroplasty in young and active patients with posterior stabilized design.
Morteza Meftah, Peter B White, Amar S Ranawat...
https://pubmed.ncbi.nlm.nih.gov/26833096Actively Recruiting
Age: 18Years +
All Genders
ID05653102
CR17-003 Truliant Knee PMCF: 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
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting data to assess the safety and effectiveness of the Truliant® knee prosthesis used in total knee replacement surgeries. This observational study aims to gather clinical and patient outcomes, including survivorship data, from individuals who have received or will receive this knee device. The study focuses on patients with various knee conditions, such as osteoarthritis, rheumatoid arthritis, and post-traumatic arthritis, who have undergone or will undergo surgery involving the Truliant® system. Participants include those enrolled before surgery, those enrolled after surgery who continue to participate prospectively, and those enrolled only retrospectively with no prospective follow-up. The study collects data from medical records and patient follow-ups over an extended period. The Truliant Total Knee System, compatible with Optetrak components, is the device being evaluated. Surgeries are performed by investigators or surgeon sub-investigators following approved device indications. During the study, participants will complete assessments using tools such as the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), Oxford Knee Score, and Visual Analog Scale (VAS) for pain at multiple time points from before surgery up to ten years post-surgery. Data collection includes demographic, operative, and postoperative information obtained from medical records and patient responses. This long-term follow-up helps researchers monitor outcomes and device performance over time, with the study expected to continue until 2035.
CONDITIONS
Brief Title
A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Skeletally mature individuals aged 18 years or older
- Willing and able to provide written informed consent
- Receiving or have received 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
- Knee replacement surgery performed by the investigator or a surgeon sub-investigator
- Use of Truliant® devices according to approved indications
- For retrospective participants, availability of demographic, operative, and relevant postoperative data in medical records
- Signed HIPAA waiver for use of clinical records if enrolled retrospectively only
You will not qualify if you...
- Patients under 18 years of age at time of surgery
- Patients who do not meet the indicated population for use criteria for the device
- Pregnant patients
- Prisoners
- Patients with physical or mental conditions that would invalidate study results
- Patients contraindicated for surgery, such as those with metal allergy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Surgical day
Participants receive a Truliant total knee replacement surgery using Exactech's Truliant branded components.
1 surgical visit
Post-operative Follow-up
Duration - Up to 10 years
Participants are monitored after surgery to collect clinical and patient outcomes and survivorship data.
Visits at 6 weeks, 6 months, 1 year, and annually up to 10 years
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
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Research Team
P
Pearl Harris
A
Alex Knisely
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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Published Research Related To This Trial
Five-year survivorship and patient-reported outcome of the Triathlon single-radius total knee arthroplasty.
Chloe E H Scott, Nick D Clement, Deborah J MacDonald...
https://pubmed.ncbi.nlm.nih.gov/24623184Long term survivorship following Scorpio Total Knee Replacement.
A Martin, C Quah, G Syme...
https://pubmed.ncbi.nlm.nih.gov/25818502