VERASENSE™ Sensor-Assisted TKA Two-Year Multicenter Study Data Demonstrates 97% Patient Satisfaction Following Total Knee Arthroplasty
New Data Presented at 2015 American Academy of Orthopaedic Surgeons Annual Meeting
DANIA BEACH, FL (March 26, 2015) – OrthoSensor Inc., a leader in Sensor-Assisted Surgery, today announced the results of the two-year VERASENSE™ Multicenter Evaluation during the American Academy of Orthopaedic Surgeons (AAOS) 2015 Annual Meeting in Las Vegas, Nevada.
Dr. Gregory Golladay, Associate Professor at Virginia Commonwealth University and a leading specialist in knee and hip reconstruction who served as a lead investigator for the multicenter evaluation, highlighted the study data during a presentation at the OrthoSensor Booth on Thursday, March 26, 2015. The data demonstrated that patients whose knees were balanced with the use of VERASENSE™ during Total Knee Arthroplasty (TKA), defined as having an intercompartmental loading difference of ≤ 15 lbs, showed statistical improvement exceeding that of unbalanced patients in Knee Society Scores (KSS) for pain and function and Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) scores. After just six months, patients whose knees were balanced with VERASENSE™ achieved scores that unbalanced patients had not yet achieved even two years after surgery.28, 32
“The two-year data from the VERASENSE™ Multicenter Evaluation further validates that VERASENSE™ balanced knees offer significant improvement in patient and clinical outcomes after sensor-assisted TKA,” said Dr. Golladay. “Balanced TKA patients scored higher on every test, experienced less pain, and had more mobility and higher satisfaction throughout the recovery process than unbalanced patients. In fact, at both the one-year and two-year end-points, 97% of balanced patients indicated they were “satisfied” or “very satisfied” with their sensor-assisted knee replacement. These overall findings support that VERASENSE™ offers a significant advantage to those in need of TKA.”*
Detailed two-year clinical data includes:
- At two years, patients whose knees were balanced with the use of VERASENSE™ achieved total average KSS scores of 178.6, exceeding the average score of unbalanced patients by 17.6 points. Balanced patients achieved an average KSS pain score of 96.2 and an average KSS function score of 82.4, scores 8.1 points and 9.5 higher than the average KSS pain and function scores of unbalanced patients, respectively.
- The balanced group achieved a WOMAC score of 11, a 6.6-point improvement than the average WOMAC score of unbalanced patients.
- Balanced patients achieved an average activity level score of 66.8, corresponding to light to moderate labor categories (tennis, light jogging, heavy yard work). Unbalanced patients’ activity level score was 47.6, well within the semi-sedentary range (light housework, walking short distances). It is important to note that balanced patients showed drastically improved activity level scores from six months to 24 months after surgery, while the average activity level scores of unbalanced patients remained relatively flat over the same time period.*
“This exciting new VERASENSE™ clinical study data demonstrates a significant and positive impact on patient activity level, pain and satisfaction,” said Ivan Delevic, President and Chief Executive Officer of OrthoSensor. “Our simple, easy-to-adopt technology has been shown to improve function and implant stability, which leads to better quality patient outcomes. We believe these findings coupled with our previously published data further establish the important role that VERASENSE™ Sensor-Assisted Surgery plays in TKA procedures.”
Studies were conducted using a sample size of 135 patients and 8 contributing surgeons. Data indicate that all patients scored in the same range regardless of site or surgeon. These data are a follow-up to six-month and one-year data that were previously published in peer-reviewed journals.28, 29, 32
About OrthoSensor, Inc.
OrthoSensor, Inc., a leader in Sensor-Assisted Total Knee Arthroplasty develops and commercializes intelligent orthopaedic devices and data services that provide quantitative feedback to surgeons and hospitals. The company’s intelligent orthopaedic devices utilize advanced proprietary sensor and communications technologies, coupled with the company’s innovative software products, to facilitate evidence-based decisions in orthopaedic surgery – with the goal of improving patient outcomes and potentially reducing the cost of treating musculoskeletal disease.
OrthoSensor® and VERASENSE™ are trademarks of OrthoSensor, Inc.
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*2-Year Clinical Outcomes, OrthoSensor Multicenter Evaluation. Pending Publication. Data on file at OrthoSensor, Inc.