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-. 8600 Rockville Pike and transmitted securely. "Torn ACLs are among the most common knee injuries in the U.S., but for years, treatment has been limited to ACL reconstruction, which can be quite invasive and typically requires using tendon or a combination of tendon and bone from other parts of the body, or obtained from a tissue bank, to complete the reconstruction," said Capt. Patients must have an ACL stump attached to the tibia to construct the repair. Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. ACL injuries are among the most common knee injuries and affect around 400,000 Americans each year. Bridge-enhanced anterior cruciate ligament repair is not inferior to autograft anterior cruciate ligament reconstruction at 2 years: results of a prospective randomized clinical trial. This change to our approach will greatly benefit our patients. This provides a healing environment for the torn ACL fibers to repair themselves together, thereby eliminating the need to harvest any tissue for a graft. Ive summarized the comparison above. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. (10) Song EK, Seon JK, Yim JH, Woo SH, Seo HY, Lee KB. The request was submitted under section 513(f)(2) of the FD&C Act. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). How many patients fail the BEAR implant and still need ACL reconstruction surgery? Copyright Regenexx 2023. Preclinical studies suggest that for complete midsubstance anterior cruciate ligament (ACL) injuries, a suture repair of the ACL augmented with a protein implant placed in the gap between the torn ends (bridge-enhanced ACL repair [BEAR]) may be a viable alternative to ACL reconstruction (ACLR). The BEAR Implant from Miach Orthopaedics was approved by the U.S. Food and Drug Administration in December 2020. Patients were unblinded after their 2-year visit. Keywords: The preliminary work is very promising, but with any new research, we need more data to confirm the early findings, Lepley says. Bridge-enhanced anterior cruciate ligament repair (BEAR) combines suture repair of the anterior cruciate ligament (ACL) with a specific extracellular matrix scaffold (the BEAR scaffold) that is placed in the gap between the torn ends of the ACL to facilitate ligament healing. Lower right panel: The sutures and extracortical buttons are secured. The technique was approved by the Food and Drug Administration in late 2020 and has been used in a handful of patients at OHSU, beginning with the first case in Oregon this past February. Is the BEAR Implant Safe? Epub 2016 Jul 27. (8) Nyland J, Klein S, Caborn DN. The typical treatment for this injury is reconstructive surgery. And as it stands, implant recipients shouldnt return to a sport for nine months after their surgery, which is similar to traditional ACL reconstruction, Fleming says. Background: 2 absorbable suture (purple) is placed into the tibial stump of the ACL. Updated December 17, 2020. Network meta-analysis of knee outcomes following anterior cruciate ligament reconstruction with various types of tendon grafts. Epub 2014 Mar 20. Mansour J, Ghanimeh J, Ghoul A, Estephan M, Khoury A, Daher M. SICOT J. Many patients never regain their full level of physical activity, even after the procedure., There are a number of advantages to repairing a ligament instead of replacing it," Murray, who founded Miach Orthopaedics, which manufactures the implant, said in a statement. "That is why, more than 30 years ago, we set out to find a way to help the ligament heal itself.". The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard Medical School, Harvard University or its affiliated academic health care centers, the NFL Players Association, Boston Childrens Hospital, or the NIH. "Today's marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.". M.M.M. Disclaimer. This quicker return to play likely represents a less severe tear type for Perc-ACLR and the use of more powerful bone marrow concentrate versus whole blood for BEAR. These initial studies demonstrated that even the first surgeries performed for this technique had similar outcomes to the current gold standard of ACL reconstruction with autograft tendon, and patients did not have to have a graft harvested from their leg, she says. Am J Sports Med. This research study is approved by the FDA and funded by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. Hypothesis: We hypothesized that patients treated with BEAR would have a noninferior . (From Murray et al.). -, Akelman MR, Fadale PD, Hulstyn MJ, et al. However, as shown above, just like an ACL reconstruction, the BEAR implant surgery still has the physician drill tunnels. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. We published the first half of a Randomized Controlled Trial last year and have completed that trial, with the full study to be published this year (15). In addition, 14% of the BEAR group and 6% of the ACLR group had a reinjury that required a second ipsilateral ACL surgical procedure (P = .32). A comprehensive, integrated, academic health system with The Warren Alpert Medical School of Brown University, Lifespan's present partners also include Rhode Island Hospital's pediatric division, Hasbro Children's Hospital; Bradley Hospital; Newport Hospital; Gateway Healthcare; Lifespan Physician Group; and Coastal Medical. The site is secure. On June 4, 2020, FDA received your De Novo requesting classification of the BEAR (Bridge-Enhanced ACL Repair) Implant. James Lacy, MLS, is a fact-checker and researcher. Registration: For those looking for a tried and tested method, and who may need to get back to activity quickly, they may want to stick with a traditional ACL repair, Getgood says. Hamstring strength indices were significantly higher in the BEAR group compared with the ACLR group (P = .0001). -. eCollection 2022 Oct. See this image and copyright information in PMC. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. The FDA reviewed the BEAR Implant through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. -, Arneja S, Leith J. A whipstitch of No. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knee's natural anatomy and function. BEAR is a new technique that uses a collagen scaffold instead of a graft to repair the ACL. When Does a Partial ACL Tear Require Surgery? If you've torn your ACL and are interested in the new implant, you should talk to your doctors to see if you are a strong candidate for the new procedure or would be better off with an ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Am J Sports Med. is an assistant editor for The American Journal of Sports Medicine, the spouse of M.M.M. Likely lowered prevalence of early arthritis and tearing the opposite ACL as the normal biomechanics of the knee are preserved. Am J Sports Med. Benefits of BEAR ACL Repair in Pediatric Patients. A doctor has to weigh which patients would be an ideal candidate to receive the implant over traditional ACL reconstruction. National Library of Medicine The BEAR Implant is available in select cities across the U.S. Dr. David Johannesmeyer is the first sports medicine surgeon to perform a BEAR Implant ACL Repair. Ortop Traumatol Rehabil. PDF December 16, 2020 - Food and Drug Administration April 16, 2020. doi:10.1177/0363546520913532. PDF Bridge-Enhanced Anterior Cruciate Ligament Repair: The Next Step The FDA reviewed the BEAR Implant through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. FOIA The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction. At the same time point, the Regenexx Perc-ACLR procedure had an 8% surgery rate, which more similar to the 6% conversion to a second surgery after ACLR surgery reported in the BEAR study. NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. FDA Authorizes Marketing of New Implant to Repair a Torn ACL In order to classify the BEAR (Bridge-Enhanced ACL Repair) Implant into class I or II, it is necessary that the government site. The International Knee Documentation Committee Subjective Knee Evaluation Form: normative data. Am J Sports Med. J Orthop Surg (Hong Kong). Glasbrenner J, Raschke MJ, Kittl C, Herbst E, Peez C, Briese T, Michel P, Herbort M, Ksters C, Schliemann B. Am J Sports Med. Epub 2013 Jun 28. We hypothesized that patients treated with BEAR would have a noninferior patient-reported outcomes (International Knee Documentation Committee [IKDC] Subjective Score; prespecified noninferiority margin, -11.5 points) and instrumented anteroposterior (AP) knee laxity (prespecified noninferiority margin, +2-mm side-to-side difference) and superior muscle strength at 2 years after surgery when compared with patients who underwent ACLR with autograft. 2019 Sep;53(18):1168-1173. doi: 10.1136/bjsports-2018-100167. Knee Surg Sports Traumatol Arthrosc. Patients must have an ACL stump attached to the tibia to construct the repair. Arthroscopy. Meaning these patients return to sports just like those who get ACLR surgery. Y.-M.Y. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. Accessibility See this image and copyright information in PMC. Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year - PubMed PMID: 33549723. BEAR and the Regenexx Perc-ACLR procedure are better than an ACLR surgery in many ways. When applied correctly to suitable patients, these two really shouldnt compete head to head in that they are focused on two different types of ACL injuries. Despite being a very common injury, until today, the only surgical treatment available for torn ACLs has been ACL reconstruction using allograft, autograft or suture-only repair. She said it had the potential to change the standard of care.. Hip Avascular Necrosis | Preservation & Replacement Data on the first patients who got the implant reporting on their six-year post-surgical outcomes is starting to come in, he says. In the study, 65 patients received the BEAR Implant and 35 members of the control group received ACL reconstruction with autograft (using their own tendon from another part of the body). Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. BEAR ACL Repair Technique | Knee Surgeon | Minnesota with the inherently same conflicts. Am J Sports Med. FOIA Dr. Owens: During the course of my career, we have seen some small incremental changes to the surgical techniques in ACL reconstruction. Study Goal Orthop J Sports Med. Hence, you would need a Regenexx network physician to look at your actual MRI images. Arthrometry measures the difference in laxity between a persons healthy leg and their injured leg. AR065462 and R01AR056834). Would you like email updates of new search results? Third, while it's unknown if knees repaired with BEAR retain their position sense, that's much more likely than the tendon graft . official website and that any information you provide is encrypted The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. eCollection 2021 Nov. Barnett S, Badger GJ, Kiapour A, Yen YM, Henderson R, Freiberger C, Proffen B, Sant N, Trainor B, Fleming BC, Micheli LJ, Murray MM, Kramer DE. -, Astur DC, Cachoeira CM, da Silva Vieira T, Debieux P, Kaleka CC, Cohen M. Increased incidence of anterior cruciate ligament revision surgery in paediatric verses adult population. However, the BEAR technology has the potential to transform the way we treat ACL injuries, with restoration of the native ligament and without the need to harvest a graft from another part of the knee. has patents/patents pending for the BEAR technology from Boston Childrens Hospital and Rhode Island Hospital, is a paid associate editor for The American Journal of Sports Medicine, has received royalties from Springer, and has received research grants from the NIH and the Department of Defense. That would be a shame, as its exposing the patient to more risk than is required to get good clinical results. Tian S, Wang B, Liu L, Wang Y, Ha C, Li Q, Yang X, Sun K. Am J Sports Med. Patients received physical therapy and were followed for two years. 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. 2023 Feb;51(2):413-421. doi: 10.1177/03635465221142323. Would you like email updates of new search results? L.J.M. Raquel Peat, Ph.D., MPH, USPHS, director of the Center for Devices and Radiological Healths Office of Orthopedic Devices, Todays marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.. Find a Surgeon. A new absorbable device known as the Bridge-Enhanced ACL Repair (BEAR) was approved by the Food and Drug Administration (FDA) to repair some anterior cruciate ligament (ACL) injuries. Am J Sports Med. No surgery, drilling, or graft tunnels are required. Schematic of the technique used to place the BEAR implant. We hypothesized that the BEAR group would have physical examination findings, patient-reported outcomes, and adverse events that were similar to those of the ACLR group. How is the BEAR implant different from reconstruction? The patient needs to have some tissue intact after the tear for the implant to work. In addition, the retear rate that were about to publish is lower for Perc-ACLR than BEAR, and most of our patients end up with a natural double-bundle repair which is less likely with BEAR. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently- available alternative to reconstruction with allograft, autograft or suture-only repair for the treatment of ACL rupture. It bridges the gap between the torn ends of a patients ACL, and the body then absorbs the implant within about eight weeks of surgery. The gold standard of ACL rupture is using a graft of tendon to replace the ACL, Fleming explains. The .gov means its official. Why? The ACL, a ligament located with the knee, is the tissue responsible for bridging the shinbone to the thigh bone. This is a bovine collagen implant inserted in the torn area of the ACL with sutures placed in graft tunnels. They had an average score of 88.9, while those who underwent traditional ACL repair had an average of 84.8. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The https:// ensures that you are connecting to the However, now a new surgical implant called BEAR is shaking up that world by offering a solution to try to regrow the torn ACL. PMC Bridge Enhanced ACL Restoration (BEAR Implant) The BEAR Implant is absorbed by the body as the ACL heals. 2020 08:00 AM Eastern Standard Time. Although ACL reconstruction is effective, the procedure has drawbacks; the . In the late 1990s, Martha Murray, MD, then an orthopedic surgeon with Boston Childrens Hospital, was researching why the ACL failed to heal on its own. Bridge-Enhanced ACL Repair (BEAR) | Lifespan To learn more, see my video below: Our research has shown that for the right type of tears, you end up with MRI and functional evidence of a repaired ACL. Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomized Clinical Trial. (11) Barenius B, Ponzer S, Shalabi A, Bujak R, Norln L, Eriksson K. Increased risk of osteoarthritis after anterior cruciate ligament reconstruction: a 14-year follow-up study of a randomized controlled trial. Please enable it to take advantage of the complete set of features!