Rotator Cuff Tear Arthropathy

LOS ANGELES, Feb. 13, 2024 /PRNewswire/ -- TETROUS, INC. unveils the addition of EnFix TAC to its family of EnFix™ demineralized bone allograft implants for use in rotator cuff surgery. The new implants will be showcased this week at the American Academy of Orthopaedic Surgeons (AAOS) annual conference in San Francisco, CA. Our technology is focused on healing the bone-to-tendon interface known as the enthesis. A regenerative medicine company guided by a team of influential surgeons, regenerative medicine scientists, and business leaders with experience in the orthopaedic space, Tetrous is focused on the unmet need in bone-to-tendon healing following orthopaedic surgery. Numerous clinical and preclinical studies show that the enthesis does not re-form following surgery, but instead results in the formation of scar tissue. Scar tissue does not allow proper transmission of tensile load from soft tissue to bone and is prone to fail. "With strong pre-clinical data and promising early clinical results showing healing at the bone-to-tendon interface following surgery using our EnFix RC demineralized bone fiber implant, we are excited to add EnFix TAC to our product line," stated John Bojanowski, Tetrous' Chief Commercialization Officer. "EnFix TAC is specifically designed to deliver the same enthesis healing properties while offering the flexibility to be used independently of the surgeon's suture anchor choice, readily accommodating surgeons who are moving to all-suture anchors." "The EnFix TAC comes in two shapes to provide optimal coverage of the bony real estate available based on the size of the rotator cuff tear," stated Andy Carter, Ph.D., Co-Founder and CTO. "Our technology is focused on healing the bone-to-tendon interface known as the enthesis. Clinical literature shows healing does not occur on its own. Whilst our initial products focus on the rotator cuff, we are also working on additional applications for ACL and achilles repair as product line extensions in the EnFix family. We were pleased to have two US patents granted in 2023 covering the EnFix devices and we continue to grow our patent portfolio." Tetrous products are currently being distributed in the United States and Australia, manufactured by established local tissue banks that have extensive experience with the technology. About Tetrous, Inc. Founded in 2019, Tetrous, Inc. utilizes next generation advanced technologies for enthesis repair in sports medicine applications. The first offerings in the EnFix family of products are EnFix RC and EnFix TAC for rotator cuff repair. Tetrous was conceived from technology developed for spine surgery. The Company is employing and expanding the technology for novel applications in sports medicine. Its core technology has been used in nearly 150,000 surgeries in spine applications. The demineralized bone fiber technology used in Tetrous products is licensed exclusively for use in sports medicine from TheraCell, an ISTO Biologics Company. EnFix™, EnFix RC™ and EnFix TAC™ are trademarks of Tetrous, Inc. For more information visit and follow us on LinkedIn ( ). View original content to download multimedia: SOURCE Tetrous

ROSEMONT, Ill., Feb. 2, 2024 /PRNewswire/ -- The 2024 Kappa Delta Ann Doner Vaughn Award was presented to the Multicenter Orthopaedic Outcomes Network (MOON) Shoulder Group for shifting the way physicians treat patients with atraumatic, symptomatic rotator cuff tears. Their research determined that physical therapy (PT), is an effective treatment for over 70% of these patients to improve pain and patient-reported outcome measures (PROMs) followed for over 10 years. This award recognizes research in musculoskeletal disease or injury with great potential to advance patient care. Continue Reading The 2024 Kappa Delta Ann Doner Vaughn Award was presented to the Multicenter Orthopaedic Outcomes Network (MOON) Shoulder Group for shifting the way physicians treat patients with atraumatic, symptomatic rotator cuff tears. To read more about the award, please click here. According to the American Academy of Orthopaedic Surgeons (AAOS), each year, almost 2 million people in the United States visit their doctors because of rotator cuff tears. This type of injury creates a significant economic burden to the U.S. health care system, as the prevalence of rotator cuff tears accelerates with age, and more than two-thirds of patients who have surgery are of working age. "When I finished my training in 1994, we were taught that surgery was the preferred way to treat a rotator cuff tear," said John E. Kuhn, MD, MS, FAAOS, chief of shoulder surgery and director of Vanderbilt Sports Medicine and director of the MOON Shoulder Group. "As the approach to treating rotator cuff tears remained unclear, we wanted a more thorough understanding of the disease to help define the indications for rotator cuff repair surgery and determine which patients would benefit from nonoperative treatment." Over the course of 10 years, the MOON Shoulder Group used their multicenter outcomes network to prospectively collect data on patients with rotator cuff disease to answer clinically important questions and better understand the natural history and treatment of rotator cuff disease. To predict failure rates of nonoperative treatment of rotator cuff tears, the group developed a standard, evidence-based PT protocol that included a "gold standard" PT protocol, with elements derived from a systematic review. The cohort study enrolled patients aged 18 to 100 years with shoulder symptoms and MRI-documented, symptomatic, atraumatic, full-thickness rotator cuff tears (where the tendon is completely detached from the bone). Patients were given two instructive rehabilitation books—one for physical therapists and another for home-based PT written at the eighth-grade level—with an accompanying DVD. The specific exercises included daily range of motion (postural exercises, active-assisted motion, active training of scapular muscles and active range of motion); daily flexibility (anterior and posterior shoulder stretching); and strengthening three times per week (rotator cuff and scapula exercises). Therapists were instructed to provide manual mobilization exercises as needed based on evidence that supports their use in impingement and to progress the patient to a home therapy program when ready. Based on the systematic review, heat and cold were recommended as modalities, but ultrasound was not.i Patient outcome scores were tracked at entry into the study and during each follow-up visit at six weeks, 12 weeks, one year, and two, five, seven and 10 years. At the six-week mark, patients were given three options: no additional follow up if they considered themselves "cured"; continue PT for six more weeks if they were "improved"; and, if they were "no better", they could elect to have surgery. At any point during the study, patients could opt to have surgery. Results from the research include: At 10 years, PT was shown to be highly effective in over 70% of patients with atraumatic, symptomatic, full-thickness rotator cuff tears in reducing pain and improving PROMs. Most patients who decided to have surgery within six months were driven primarily by their expectations of the effectiveness of physical therapy. In other words, if they thought PT would work, it worked. If they didn't believe it would work, it didn't. When comparing those who had surgery before six months and those who had surgery between six months and 10 years, worker's compensation status and activity level were more important in predicting the need for surgery after 6 months. Structural factors (tear size, retraction), visual analog pain score and weakness were not predictors of having surgery and are likely not helpful in determining surgical indications. There was no correlation between rotator cuff tear anatomy and pain, the duration of symptoms, and patient activity level. "Our team was shocked when so many patients in the cohort improved with physical therapy, because it's not at all what we expected," said Kuhn. "We're also optimistic about the finding that low expectations for therapy drives patients to having surgery because we can modify this variable by educating patients that physical therapy can work." The MOON Shoulder Group and other surgeons are engaged in the Arthroscopic Rotator Cuff Trial, a multicenter, randomized trial funded by the Patient Centered Outcomes Research Institute, where patients with symptomatic, atraumatic full-thickness rotator cuff tears are randomized to either treatment with PT or surgical repair of their rotator cuff tear to help determine which treatment option might be best suited for a particular patient. In addition to Dr. Kuhn, the MOON Shoulder Group includes the following researchers: Warren R. Dunn, MD, MPH, FAAOS, Rosemary Sanders, BA, Keith M. Baumgarten, MD, FAAOS, Julie Y. Bishop, MD, FAAOS, Robert H. Brophy, MD, FAAOS, James L. Carey, MD, MPH, FAAOS, Brian G. Holloway, MD, Grant L. Jones, MD, FAAOS, C. Benjamin Ma, MD, FAAOS, Robert G. Marx, MD, MS, FAAOS, Eric C. McCarty, MD, FAAOS, Sourav K. Poddar, MD, Matthew V. Smith, MD, FAAOS, Edwin E. Spencer, MD, FAAOS, Armando F. Vidal MD, FAAOS, Brian R. Wolf, MD, MS, FAAOS, and Rick W. Wright, MD, FAAOS. About the Kappa Delta Awards In 1947, at its golden anniversary, the Kappa Delta Sorority established the Kappa Delta Research Fellowship in Orthopaedics, the first award ever created to honor achievements in the field of orthopaedic research. The first annual award, a single stipend of $1,000, was made available to the AAOS in 1949 and presented at the AAOS meeting in 1950. The Kappa Delta Awards have been presented by the AAOS to persons who have performed research in orthopaedic surgery that is of high significance and impact. The sorority has since added two more awards and increased the award amounts to $20,000 each. Two awards are named for the sorority national past presidents who were instrumental in the creation of the awards: Elizabeth Winston Lanier and Ann Doner Vaughn. The third is known as the Young Investigator Award. For more information about the manuscript submission process, please visit aaos.org/kappadelta. Learn more about the Kappa Delta Foundation, here. About the AAOS With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world's largest medical association of musculoskeletal specialists. The AAOS is the trusted leader in advancing musculoskeletal health. It provides the highest quality, most comprehensive education to help orthopaedic surgeons and allied health professionals at every career level to best treat patients in their daily practices. The AAOS is the source for information on bone and joint conditions, treatments and related musculoskeletal health care issues; and it leads the health care discussion on advancing quality. Follow the AAOS on Facebook, X, LinkedIn and Instagram. Disclosure Funding and Conflicts of Interest For a list of disclosures, funding and conflicts of interest, email [email protected]. i Kuhn JE. Exercise in the treatment of rotator cuff impingement: a systematic review and a synthesized evidence-based rehabilitation protocol. J Shoulder Elbow Surg. 2009 Jan-Feb;18(1):138-60. SOURCE American Academy of Orthopaedic Surgeons

First published randomized controlled trial for market-leading implant demonstrates impressive outcomes for rotator cuff tears Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces standout results for its REGENETEN Bioinductive Implant from a recently completed randomized controlled trial (RCT). Published online in Arthroscopy in December, the report concluded that at one-year, medium and large full-thickness rotator cuff tears repaired and augmented with the REGENETEN Bioinductive Implant had better tendon healing compared to the standard of care,1 as evidenced by: A significantly lower re-tear rate (8.3 vs 25.8%; p=0.01)A three times lower risk of re-tear (RR=0.32; 95% CI:0.13–0.83)No difference in the number of serious or minor complications The blinded, multi-centre RCT compared the healing rate of full-thickness rotator cuff tears repaired with and without augmentation with the REGENETEN Bioinductive Implant. In total, 124 patients with reparable medium and large (1–4cm) full-thickness posterosuperior rotator cuff tears were randomized to receive either an arthroscopic transosseous equivalent double-row rotator cuff repair or the same repair augmented with the REGENETEN Bioinductive Implant. Dr. Miguel Ruiz Ibán, Head of the Shoulder and Elbow Unit at Hospital Universitario Ramón y Cajal in Madrid, Spain, and Principal Investigator for the study commented on the results, “Rotator cuff repair is traditionally associated with re-tear rates in excess of 20%, presenting a challenge for surgeons and patients alike. This RCT demonstrates that the REGENETEN Bioinductive Implant substantially and significantly reduced this risk. With no increase in complications seen in our study, these findings support the use of the implant to reduce re-tear rates in the population studied.” With more than 100,000 procedures completed globally since its introduction in 2014, the REGENETEN Bioinductive Implant has had a transformative impact, offering a better solution for more than 1 million2 people having surgery for a rotator cuff tear each year. The collagen-based implant supports the body’s natural healing response to facilitate the formation of new tendon-like tissue to biologically augment the existing tendon and change the course of rotator cuff tear progression.1,3-8 Smith+Nephew's REGENETEN Bioinductive Implant “Smith+Nephew is committed to proving the value of our technology through support for clinical evidence generation,” said Christie Van Geffen, SVP Sports Medicine Global Marketing at Smith+Nephew. “We are pleased and excited by the opportunity presented by this evidence to drive adoption of, and access to, the REGENETEN Bioinductive Implant. Our goal is to help surgeons improve the care of many more patients with rotator cuff injuries.” The REGENETEN Bioinductive Implant is part of Smith+Nephew’s comprehensive Advanced Healing Solutions portfolio – redefining biological healing in rotator cuff repair. To learn more about the REGENETEN Bioinductive Implant, please click here. - ends - Media Enquiries David SnyderSmith+Nephew +1 978-749-1440 david.snyder@smith-nephew.com References Ruiz Ibán MA, Navlet MG, Marco SM, et al. Augmentation of a transosseous equivalent repair in posterosuperior non-acute rotator cuff tears with a bioinductive collagen implant decreases the re-tear rate at one year. A randomised controlled trial. Arthroscopy. Published online 12/27/2023.iData Research. Rotator cuff repair and reconstruction market size, share and trends analysis (2023). Available at: https://idataresearch.com/product/rotator-cuff-repair-reconstruction-market-size-share-and-trends-analysis-global-2023-2029-medsuite-includes-grafts-allografts-xenograft-synthetic-and-1-more/#. Accessed December 19, 2023.Bokor DJ, Sonnabend D, Deady L, et al. Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up. Muscles, Ligaments Tendons J. 2016;6(1):16-25.Schlegel TF, Abrams JS, Bushnell BD, Brock JL, Ho CP. Radiologic and clinical evaluation of a bioabsorbable collagen implant to treat partial-thickness tears: a prospective multicenter study. J Shoulder Elbow Surg. 2018 27(2):242-251.Van Kampen C, Arnoczky S, Parks P, et al. Tissue-engineered augmentation of a rotator cuff tendon using a reconstituted collagen scaffold: a histological evaluation in sheep. Muscles Ligaments Tendons J. 2013;3(3):229-235.Arnoczky SP, Bishai SK, Schofield B, et al. Histologic Evaluation of Biopsy Specimens Obtained After Rotator Cuff Repair Augmented With a Highly Porous Collagen Implant. Arthroscopy. 2017;33(2):278-283 Bokor DJ, Sonnabend DH, Deady L, et al. Healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a highly porous collagen implant: a 5-year clinical and MRI follow-up. Muscles, Ligaments Tendons J. 2019;9(3):338-347.McElvany MD, McGoldrick E, Gee AO, Neradilek MB, Matsen FA, 3rd. Rotator cuff repair: published evidence on factors associated with repair integrity and clinical outcome. Am J Sports Med. 2015;43(2):491-500. About Smith+NephewSmith+Nephew is a portfolio medical technology company focused on the repair, regeneration and replacement of soft and hard tissue. We exist to restore people’s bodies and their self-belief by using technology to take the limits off living. We call this purpose ‘Life Unlimited’. Our 19,000 employees deliver this mission every day, making a difference to patients’ lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global business units of Orthopaedics, Sports Medicine & ENT and Advanced Wound Management. Founded in Hull, UK, in 1856, we now operate in more than 100 countries, and generated annual sales of $5.2 billion in 2022. 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