Rotator cuff experts, Rotation Medical Inc., tell us about positive initial results for the REBUILD registry of the company’s Bioinductive Implant.
Background
Traditional approaches to treating degenerate or torn rotator cuffs often do not address the poor quality of the underlying tendon tissue, and a significant number of these tendons, after standard treatment, either degenerate further and/or re-tear.
The Rotation Medical Bioinductive Implant is designed to address both the biomechanics and biology required to heal a rotator cuff tendon tear by inducing new tissue growth at the site of implantation. This results in increased tendon thickness and healing of tendon defects with new tissue growth. The collagen-based implant is about the size of a postage stamp and it is part of the Rotation Medical rotator cuff system, which also includes disposable instruments that allow the arthroscopic procedure to be performed easily and quickly
Presented at the Arthroscopy Association of North America (AANA) Annual Meeting, the REBUILD registry adds to the growing body of literature supporting the use of the Rotation Medical Bioinductive Implant as a novel treatment for rotator cuff injury.
REBUILD (Rotation MEdical BioindUctive ImpLant Database) is a prospective, non-randomized, multicenter registry designed to collect patient reported outcomes, including shoulder function, pain and quality of life after receiving the Bioinductive Implant. Interim results of the first 200 patients showed significantly less post-operative pain and use of narcotics, less sling time, faster return to function and better overall shoulder rating. The study will follow up to 300 patients across 20 study centers.
When compared to data in a national orthopaedic database using standard rotator cuff treatment, patients in the REBUILD registry report feeling better six months after receiving the Bioinductive Implant than those who received standard treatment did at two years.
Investigator comments
“Patients often opt out or delay surgery in the early stages of rotator cuff disease due to long and painful rehabilitation,” said Dr. Louis McIntyre, study investigator and orthopedic surgeon at Northwell Health Physician Partners Orthopaedic Institute at Sleepy Hollow, New York. “Initial results of the REBUILD registry demonstrate statistically significant improvements in several outcomes measures, including pain, function and overall shoulder rating.”
Company comments
“Payors and providers are increasingly looking for data that demonstrate the effectiveness of medical devices on key health economic drivers,” said Martha Shadan, president and CEO of Rotation Medical. “With the results of the REBUILD registry, we believe our Bioinductive Implant is well-positioned to transform the treatment of rotator cuff disease, enabling patients to get back to work and other activities more quickly with less pain and use of narcotics than traditional rotator cuff repair.”
Source: Rotation Medical, Inc.
published: May 18, 2017 in: Clinical Studies/Trials, Congresses and Meetings, Shoulder