Clareo Health | Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty (TKA)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Orthosensor, Inc.
Hypothesis: TKA with VERASENSE results in a more reliable and precise option for establishing implant-to-implant congruency and joint balance leading to less knee pain, faster return to normal activities and higher patient satisfaction compared to TKA without VERASENSE.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Patients who meet the indications for use for Triathlon® Total Knee System using VERASENSE™
Subject must be diagnosed with one or more of the following conditions
osteoarthritis
rheumatoid or other inflammatory arthritis
post-traumatic arthritis
Subject is likely to be available for all study visits
Subject is able and willing to sign the informed consent and follow study procedures
You may not be if
Prior Total Knee Arthroplasty
Avascular Necrosis
Any knee surgery other than meniscectomy (can be arthroscopic or open)
Ligament insufficiencies, prior surgeries such as anterior cruciate ligament (ACL) or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
Ipsilateral foot/ankle and hip arthritis
Range of motion less than 90°, flexion contracture greater than 20°
Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
Any subjects meeting any contraindication criteria as identified in the locally approved labeling for the device should be excluded from this study.
