A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System
Recruiting now
Conditions studied: Knee Arthroplasty, Total
In brief
A Post-Market Domestic (US) and International Data Collection to Assess the Truliant® Knee System
Key facts
- Study ID
- NCT05653102
- Run by
- Exactech
- People needed
- 1000
- Starts
- 2019-01-23
- Expected to finish
- 2035-07-31
- Last updated by the study team
- 2024-06-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Cohort 1. Prospective / Subjects- Enrolled in the study pre-surgery
- Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study.
- Skeletally mature (18 years of age or older).
- Subject is willing and able to provide written informed consent for participation in the study.
- 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.
- The knee replacement will be performed by the investigator or a surgeon sub-investigator.
- The devices will be used according to the approved indications.
- Cohort 2. Retrospective to Prospective / Subjects enrolled in the study post- surgery then continue to participate in the study prospectively.
- Subjects who agree to participate in the study that have undergone surgery prior to enrollment in the study. Data for these subjects will collected from the subject's medical record for the time period prior to enrollment in the study containing data pertaining to the index surgery (retrospective data) and from the patient after they are enrolled in the study during the post-operative time period (prospectively).
- Skeletally mature (18 years of age or older).
- Subject is willing and able to provide written informed consent for participation in the study.
- Subject 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.
- The knee replacement was performed by the investigator or a surgeon sub-investigator.
- The devices are/were used according to the approved indications.
- Special consideration should be taken to ensure that these subjects meet all inclusion criteria, none of the exclusion criteria, and have a minimum of the following pre-operative, operative, and applicable postoperative data available in the subject's medical records, related to the Truliant® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA). Prior to inclusion in the study, the following details must be available for data submission: Pre-Operative:
- o Demographic Data
- Gender
- Age at surgery
- Height/Weight
- Indication for surgery
- Prior Injuries/Surgeries on index knee
- Comorbidities
- Operative:
- Date of Surgery
- Type of Surgery (Primary / Revision)
You may not qualify if…
- Patient was <18 years of age at time of surgery
- Patient does not meet indicated population for use criteria for this device
- Patient is pregnant
- Patient is a prisoner
- Patient has a physical or mental condition that would invalidate the results
- Patient is contraindicated for the surgery (e.g., metal allergy)
Where it is running
- University of Colorado Health — Aurora, Colorado, United States (enrolling)
- Florida Research Associates — DeLand, Florida, United States (enrolling)
- Nevada Orthopaedic and Spine Center — Las Vegas, Nevada, United States (enrolling)
- Crystal Clinic — Akron, Ohio, United States (enrolling)
- Medical University South Carolina — Charleston, South Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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