Status:
TERMINATED
Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty (TKA)
Lead Sponsor:
Orthosensor, Inc.
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist the surgeon with tibiofemoral rotational alignment by testing the precision and variability of setting tray ...
Detailed Description
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 activit...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT02286739
Start Date
April 1 2015
End Date
May 1 2020
Last Update
August 19 2024
Active Locations (6)
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1
The Cleveland Clinic Foundation
Weston, Florida, United States, 33331
2
Emory University
Atlanta, Georgia, United States, 30329
3
Illinois Bone & Joint Institute
Morton Grove, Illinois, United States, 60053
4
NYU Hospital for Joint Diseases
New York, New York, United States, 10003