Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During TKA

Status:	Recruiting
Conditions:	Arthritis, Osteoarthritis (OA)
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	4/6/2017
Start Date:	April 2015
End Date:	December 2018
Contact:	Christopher R. Anderson, MS, MBA
Email:	canderson@orthosensor.com
Phone:	(954) 372-2641

Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty

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 rotation to the mid-third of the tibial tubercle. 2) Understand if patients
with a combined axial rotation couple at the tibiofemoral joint and quantitative
intercompartmental balance, achieved with the use of VERASENSE, exhibit less post-operative
knee pain and improved clinical outcomes. Radiographic outcomes will also be assessed to
measure post-operative alignment and to evaluate the prevalence and location of radiolucency
and/or osteolysis.

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.

Inclusion Criteria:

- 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 Criteria:

- Prior Total Knee Arthroplasty

- Avascular Necrosis

- Any knee surgery other than meniscectomy (can be arthroscopic or open)

- Ligament insufficiencies, prior surgeries such as 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.

We found this trial at

sites

NYU Hospital for Joint Diseases

New York, New York 10003

Principal Investigator: Ivan Fernandez-Madrid, MD

from

New York, NY