Patients with massive rotator cuff tears are being enrolled in an ongoing FDA study of the InSpace System through UBMD Orthopaedics & Sports Medicine.
“A tremendous number of people live with terrible pain from massive rotator cuff tears,” Dr. Matthew DiPaola, a shoulder and elbow surgeon with the practice, said in a news release. “In collaboration with Buffalo General Medical Center, we are pleased to be one of the 20 study sites evaluating the InSpace System, a minimally invasive approach to treating this difficult condition.”
Rotator cuff tears are a main source of shoulder pain in adults, leading to sleepless nights and difficulty performing everyday tasks. Treatment ranges from cortisone injections and physical therapy to surgery. Still, relief is elusive for some.
The InSpace device is a biodegradable balloon spacer implanted arthroscopically in the shoulder to relieve pain and improve function.
The study is designed to assess the safety and effectiveness of the new device, which has been implanted in more than 10,000 patients in 15 countries, DiPaola said.
Doctors in the U.S. and Canada are in the midst of a single-blinded, randomized, controlled study that will enroll up to 184 patients in North America. Eligible patients must be at least 40 years old with imaging-confirmed, full-thickness rotator cuff tears, and have documented failure of conservative therapy. Enrolled subjects are randomized to undergo arthroscopic implantation of the InSpace device or arthroscopic partial repair the tears.
For more information, call 204-3200.