Rotation Medical Inc., a medical device company focused on developing new technologies to treat rotator cuff disease, announced results of the first study of the company’s collagen-based Bioinductive Implant on patients with large and massive rotator cuff tears. The results, which were presented at the American Academy of Orthopaedic Surgeons (AAOS) in San Diego, showed the Bioinductive Implant induced new tissue formation in all study participants.
“Failure of large and revision rotator cuff repairs continues to be a challenging problem,” says Felix H. “Buddy” Savoie, MD, study investigator and chairman of the Department of Orthopedics at Tulane University School of Medicine in New Orleans. “This study is exciting for the field of rotator cuff repair, as it showed that the Bioinductive Implant induces new tissue formation and assists in healing for patients with large and massive rotator cuff tears.”
The study enrolled 23 patients – 11 with large (two tendon) and 12 with massive (three tendon) rotator cuff tears – 16 of whom had previous rotator cuff repairs. All patients received the Rotation Medical Bioinductive Implant via arthroscopic surgery. New tissue formation was observed in all 23 patients, and 22 successfully healed their rotator cuffs. Postoperative ultrasound was used to assess tendon thickness at three, six and 12 months, and MRIs were taken at six and 12 months to confirm healing and tendon thickness. Rotator cuff thickness ranged from five to nine millimeters at most recent follow-up, and all clinical scores improved significantly over time.
“Results of this study are consistent with the biopsy study published last month in Arthroscopy showing that our Bioinductive Implant promotes the growth of tendon-like tissue,” says Martha Shadan, president and CEO of Rotation Medical. “There is a growing body of evidence demonstrating that the Rotation Medical Rotator cuff system has the potential to transform the treatment of rotator cuff disease by addressing both the biomechanics and biology required to heal a rotator cuff tendon tear.”
The study, “Preliminary Investigation of a Bio-Inductive Collagen Patch used on Large/Massive Rotator Cuff Tears,” adds to the growing body of literature supporting the use of the Bioinductive Implant as a novel and effective treatment for rotator cuff tears. Additional publications and information about the Rotation Medical rotator cuff system are available on the company’s website.