LAKE FOREST, Calif., Dec. 17, 2015 /PRNewswire/ — A 3-year prospective medical study conducted in collaboration between Singapore General Hospital and the Mayo Clinic, between June 2011 and November 2014 has concluded that treatment with Tenex Health’s TX System provides sustained pain relief and functional improvement for patients suffering from Lateral Epicondylitis (Tennis Elbow).
Published in the American Journal of Sports Medicine, “Ultrasonic Percutaneous Tenotomy for Recalcitrant Lateral Elbow Tendinopathy: Sustainability and Sonographic Progression at 3 Years” documents the post-procedure experience of 20 patients, assessing pain relief as measured by the visual analog scale (VAS), quality of life measured by the Disability of Arm Shoulder and Hand (DASH)-Compulsory/Work Scores, need for additional procedures, and overall patient satisfaction. In the study 100% of patients expressed satisfaction with their treatment. Pain relief (VAS), improved from a baseline average of 5.4 to 2.0 at 3 months, 0.7 at 12 months and 0.4 at 36 months. Statistically significant benefit was observed in the DASH-Compulsory scores from 27.8 average at baseline to 0.4 at 36 months. No patient or product complications were observed in this study.
These results were achieved with a single treatment with the TX System and patients required no adjunctive or subsequent care. The study also showed that percutaneous tenotomy using the Tenex Health TX System is one of the few procedures that promotes post-procedure healing of tissue in the affected elbow.
Dr. Joyce Koh, co-author of the study, commented that “Patients suffering from recalcitrant response have limited solutions to address their pain and compromised function. The percutaneous tenotomy using the Tenex Health TX1 Microtip is an attractive alternative to surgical intervention for definitive treatment. All the patients tolerated the procedure well and underwent a short recovery period as compared to surgery.”
“This is an impressive study in its quality of documentation and length of follow-up in this patient population that has to date been provided limited options to treat their chronic pain. This strong safety profile of the TX1 Microtip provides an inherent benefit to surgery and with this study along with other supportive literature, it appears to have compelling clinical results to warrant treatment of patients with lateral epicondylosis who are not responsive to conservative measures,” remarked Dr. Bernard Morrey. Dr. Morrey is the Past-President of the American Academy of Orthopedic Surgeons, Emeritus Chair of the Department of Orthopedics, Mayo Clinic, and Chief Medical Officer of Tenex Health.
Percutaneous tenotomy using the Tenex Health TX System is a minimally invasive surgical procedure for the treatment of tendinosis that does not require a large incision like traditional surgery. It may allow patients to recover more quickly than with traditional surgery. The Tenex Health TX System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
While the clinical article did highlight positive outcomes associated with this study, it should be noted that the following limitations are present: small sample size and lack of a control group.
To learn more about the Tenex Health TX technology, visit us at www.tenexhealth.com
*Tenex Health provided the equipment used in the study.
**Dr. Bernard Morrey is an employee of Tenex Health.