Orthopaedic Associates Taking Part in U.S. Clinical Study on Carpal Tunnel Treatment With Ultrasound Guidance

Orthopaedic Associates has enrolled its first patient in the Trial of Ultrasound Guided Carpal Tunnel Release (CTR) Versus Traditional Open Release (TUTOR) — the first multicenter randomized controlled trial in the United States to compare the efficacy and safety of traditional mini-open carpal tunnel release (mOCTR) and carpal tunnel release using the FDA-cleared UltraGuideCTR and real-time ultrasound guidance. Orthopaedic Associates is one of nine orthopaedic hand surgery sites participating in the study.

Dr. James Watt, an orthopaedic hand surgeon with Orthopaedic Associates, enrolled the first patient in the post-market TUTOR study. “I am honored to be an investigator in the TUTOR study and provide UltraGuideCTR and real-time ultrasound guidance as a safe and proven option to treat my patients suffering from debilitating carpal tunnel syndrome,” said Dr. Watt. “I believe this technique is the biggest game changer in how carpal tunnel will be treated. I look forward to using this minimally invasive approach to help patients recover faster and return to enjoying the activities they couldn’t do prior to being treated.”

Traditional mOCTR procedures to treat patients suffering from debilitating carpal tunnel syndrome (CTS) are performed by making an incision in the base of the palm (i.e., a palmar incision) and then dividing the transverse carpal ligament to relieve pressure on the median nerve. A CTR procedure using real-time ultrasound guidance enables physicians to make a small wrist incision (rather than a palmar incision) and use real-time ultrasound guidance to visualize the anatomy throughout the procedures. This less-invasive approach (as compared to an mOCTR) allows most patients to resume activities in a matter of days versus weeks or months with the traditional surgical approach.

“Both surgeons and patients prefer the smallest incisions possible so patients can quickly get back to doing the things they love,” said Dr. Kyle Eberlin, associate professor of surgery at Harvard Medical School, a plastic and reconstructive surgeon at Massachusetts General Hospital and the study’s principal investigator. “The TUTOR study gives the investigators the opportunity to undertake a disciplined comparative assessment of an approach to treat CTS that requires only a very small incision while using ultrasound guidance to maintain visualization of the anatomy throughout the procedure.”

TUTOR investigators and sites include:

  • The study’s principal investigator: Kyle R. Eberlin, M.D. — Massachusetts General Hospital, Boston.
  • Christopher J. Dy, M.D., M.P.H., F.A.C.S. — Washington University Physicians, St. Louis.
  • Mark D. Fischer, M.D. — Twin Cities Orthopedics, Minneapolis.
  • James L. Gluck, M.D. — Kansas Orthopaedic Center, Wichita, Kansas.
  • F. Thomas D. Kaplan, M.D., F.A.A.O.S. — Indiana Hand to Shoulder Center, Indianapolis.
  • Thomas J. McDonald, M.D. — Sierra Orthopedic Institute, Sonora, California.
  • Alexander Palmer, D.O. — Sano Orthopedics, Kansas City, Missouri.
  • Marc E. Walker, M.D. — University of Mississippi Medical Center, Jackson, Mississippi.
  • James F. Watt, D.O. — Orthopaedic Associates, Destin, Florida.

Data and Safety Monitoring Board (DSMB) members include:

  • The study’s DSMB chair and independent medical reviewer: Kevin C. Chung, M.D., M.S., professor of surgery, plastic surgery and orthopaedic surgery — University of Michigan Medical School, Ann Arbor, Michigan.
  • Julie E. Adams, M.D., professor of orthopaedic surgery — University of Tennessee College of Medicine, Chattanooga, Tennessee.
  • Warren C. Hammert, M.D., D.D.S., professor of orthopaedic surgery — Duke University School of Medicine, Durham, North Carolina.

“We are very grateful for the impressive depth and breadth of clinical hand surgery knowledge and experience that each of the TUTOR investigators and members of the Data and Safety Monitoring Board bring to this study — which is the first CTR randomized controlled trial in the United States,” said Sonex Health CEO Bob Paulson. “We sincerely appreciate the commitment of the TUTOR investigators to independently evaluate the clinical and health economics benefits of using UltraGuideCTR and real-time ultrasound guidance to treat the painful and debilitating effects of carpal tunnel syndrome.”

UltraGuideCTR is a single-use, hand-held device developed by the physician co-founders of Sonex Health — Dr. Darryl Barnes and Dr. Jay Smith — both of whom previously practiced at the Mayo Clinic in Rochester, Minnesota, and founded the Institute of Advanced Ultrasound Guided Procedures, which focuses on product innovation, clinical research and educating physicians on how to hone their musculoskeletal ultrasound skills. UltraGuideCTR is indicated for the treatment of carpal tunnel syndrome.

To learn more about UltraGuideCTR at Orthopaedic Associates, call 850-863-2153.