UBMD Orthopaedics & Sports Medicine has begun enrolling patients with massive rotator cuff tears (MRCT) in an ongoing FDA study of the InSpace™ System (Orthospace Inc., Caesarea Israel). Four patients have been enrolled in the study to date with a goal of enrolling at least 10 by early 2018.
The study is being led by Matthew DiPaola, MD, a shoulder and elbow surgeon with UBMD Orthopaedics & Sports Medicine and clinical Assistant Professor of Orthopaedics in the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo.
“A tremendous number of people live with terrible pain from massive rotator cuff tears,” Dr. DiPaola said. “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.”
Buffalo General Medical Center, part of Kaleida Health, is the only hospital in Western New York to be participating in the trial in partnership with UBMD Orthopaedics & Sports Medicine.
Rotator cuff tears are one of the main sources of shoulder pain in adults, leading to sleepless nights and difficulty performing everyday tasks.
The incidence of rotator cuff tears increases with age. As such, with an aging population, the rate is expected to rise in the coming years.
Treatment for rotator cuff tears range from cortisone injections and physical therapy to surgery. However, for some patients, relief is elusive.
Dr. DiPaola added that patients of UBMD Orthopaedics & Sports Medicine benefit from the practice’s affiliation as part of UBMD Physicians’ Group with the Jacobs School of Medicine and Biomedical Sciences.
“Part of our mission is to conduct research to seek out the newest and best evidence-based approaches to diagnosing and treating our patients,” he said. “Our participation with the InSpace™ clinical trial is a perfect example of that process.”
The InSpace™ device is a biodegradable balloon spacer implanted arthroscopically (a minimally invasive surgical technique in which a small tube is inserted into a joint) in the shoulder, to relieve pain and improve function in patients with a MRCT.
“The new technology that we are evaluating in this study has been found to be safe and effective in studies done overseas. In North America, it has the potential to provide new surgical options to address an unmet clinical need,” states Dr. DiPaola.
The InSpace™ System is currently being evaluated in a prospective, single-blinded, multi-center, randomized, controlled study that will enroll up to 184 patients in North America. The study is designed to assess the safety and effectiveness of the new device.
Eligible patients are at least 40 years of age with imaging-confirmed full-thickness MRCTs, and have documented failure of conservative therapy – in addition to meeting other criteria. Enrolled subjects are randomized to undergo arthroscopic implantation of the InSpace™ device or arthroscopic partial repair of MRCTs.
InSpace™ is currently commercially available outside of the United States and has been implanted in over 10,000 patients in 15 countries. The InSpace™ System is investigational in the U.S. and Canada. Details for the clinical study, including participating institutions and complete eligibility requirements, are available at ClinicalTrials.gov under identifier NCT02493660.