Murray MM, Fleming BC, Badger GJ; BEAR Trial Team; Freiberger C, Henderson R, Barnett S, Kiapour A, Ecklund K, Proffen B, Sant N, Kramer DE, Micheli LJ, Yen YM. 1991;14(3):114120. Federal government websites often end in .gov or .mil. Murray MM, Flutie BM, Kalish LA, Ecklund K, Fleming BC, Proffen BL, Micheli LJ. 2013 Dec;20(6):532-6. doi: 10.1016/j.knee.2013.07.008. Background: Am J Sports Med. The caveat about using the implant is that the technique is most effective if the ligament ruptures mid-substance, or about the middle of the ligament, to provide two ends that are able to be sutured together. Network meta-analysis of knee outcomes following anterior cruciate ligament reconstruction with various types of tendon grafts. Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year - PubMed J Orthop Sports Phys Ther. Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. She said it had the potential to change the standard of care.. (14) Nomura Y, Kuramochi R, Fukubayashi T. Evaluation of hamstring muscle strength and morphology after anterior cruciate ligament reconstruction. However, given that BEAR is a new technology, most surgeons are unlikely to allow a return to sports at six months. Further work is planned . The FDA granted the marketing authorization to Miach Orthopaedics, Inc. Outcomes-including the IKDC Subjective Score, the side-to-side difference in instrumented AP knee laxity, and muscle strength-were assessed at 2 years by an independent examiner blinded to the procedure. The BEAR Implant is the first medical advancement to enable your body to heal its own torn anterior cruciate ligament (ACL). The preliminary work is very promising, but with any new research, we need more data to confirm the early findings, Lepley says. B.C.F. Lower left panel: The free suture ends (green) at the tibial end of the BEAR implant (which was positioned between the 2 ends of the torn ACL) are passed through the tibial tunnel to be tied over a second extracortical button. 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. A doctor has to weigh which patients would be an ideal candidate to receive the implant over traditional ACL reconstruction. The implant is aimed at patients at least 14 years of age who have experienced a complete ACL rupture confirmed with magnetic resonance imaging (MRI) scan. Harvard Health Publishing. Preserve and heal the . L.J.M. Keywords: When a patient tears the Anterior Cruciate Ligament (ACL) in the knee and physical therapy cannot return that individual to sports, ACL reconstruction surgery (ACLR) is usually the next step. sharing sensitive information, make sure youre on a federal Read our. Murray MM, Kalish LA, Fleming BC; BEAR Trial Team; Flutie B, Freiberger C, Henderson RN, Perrone GS, Thurber LG, Proffen BL, Ecklund K, Kramer DE, Yen YM, Micheli LJ. Like the ACLR surgery, the BEAR implant only focuses on repairing a single bundle, so the knee is more likely to remain rotationally unstable. Thank you, {{form.email}}, for signing up. On the other hand, those in the control group had a laxity in the treated knee of 1.77 mm. That's a big deal, because until now your ACL would have been replaced with either another tendon from your body or a tendon from a deceased donor. The BEAR III trial was designed to evaluate the effects of age on outcomes following the BEAR procedure. official website and that any information you provide is encrypted has received educational support and hospitality payments from Kairos Surgical. M.M.M. Am J Sports Med. 2021 Apr;29(4):518-526. doi: 10.1016/j.joca.2021.01.004. The problem is that the recent research from Harvard shows that drilling these graft tunnels likely means a significant second severe inflammatory hit to the cartilage (2-4). Updated December 17, 2020. At two years, control subjects had a laxity that, on average, was greater by 1.8 mm in the treated knee than that of the untreated knee. One of the most important findings of her research is that performing an ACL repair is very difficult, and it explains why initial attempts in the 1970's and 1980's did not work . Bridge-Enhanced ACL Repair vs ACL Reconstruction 2021 Jun;39(6):1281-1288. doi: 10.1002/jor.24783. If those that undergo the BEAR procedure return to sports faster and have lower rates of re-injury and osteoarthritis, it is definitely possible that it could become the new gold standard.. Epub 2013 Aug 18. Bridge-enhanced Anterior Cruciate Ligament Repair (BEAR) Implant It is a . 2009;17(2):162169. Bookshelf Miach Orthopaedics' Bridge-Enhanced ACL Repair (BEAR) Implant has received marketing approval for the treatment of anterior cruciate ligament tears. Patients received physical therapy and were followed for two years. So far, so good, Fleming reports. How The BEAR Implant Works To Heal ACL Tears When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. Federal government websites often end in .gov or .mil. The FDA granted marketing authorization for an implant to repair the injury. The Bridge-Enhanced ACL Repair (BEAR) Implant is an alternative to ACL reconstruction, which typically requires harvesting tendonsand sometimes bonefrom another part of the patients body or a deceased donor. Epub 2014 Mar 20. BEAR Implant | ACL Restoration | Miach Orthopaedics 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. At two years, subjects who received the BEAR implant had a laxity that, on average, was greater by 1.7 mm (about the same as the thickness of a penny) in the treated knee than that of the untreated knee. 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. Joint Fluid Proteome after Anterior Cruciate Ligament Rupture Reflects an Acute Posttraumatic Inflammatory and Chondrodegenerative State. PMID: 24646218. Within eight weeks, the body absorbs the implant and replaces it with new tissue that gets stronger over time. Find a Surgeon - ACL Implant and Treatment Options | BEAR Implant Schematic of the technique used to place the BEAR implant. That may be tough to do using an MRI report, as the reading radiologist often doesnt differentiate between the two tear types. (A) The torn anterior cruciate ligament (ACL) tissue is preserved. eCollection 2023 Apr. The site is secure. In theory, this is ideal, as it would be healing of native tissue to the knee and not require injuring a different portion of the body to just fix another, Lepley tells Verywell. Today, the U.S. Food and Drug Administration granted marketing authorizationunder the De Novo premarket review pathwayfor an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears. Background: While a sex effect on outcomes following anterior cruciate ligament (ACL) reconstruction surgery has been previously documented, less is known following bridge-enhanced ACL repair (BEAR). Two years after surgery, the outcomes of the two procedures proved to be similar in young and active patients, though the BEAR patients had better hamstring muscle strength. National Library of Medicine Accessibility 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. In a statement, Martha Shadan, president and CEO of Miach Orthopaedics, said the implant represented the first substantial advancement in the treatment of ACL tears in decades. Vandenrijt J, Callenaere S, Van der Auwera D, Michielsen J, Van Dyck P, Heusdens CHW. Copyright Regenexx 2023. ACL (anterior cruciate ligament) injuries. Dr. Hulstyn: Female athletes are at 2-8 times greater risk of primary ACL injury compared with males, even when controlling for sport and competition level. How is BEAR different than ACLR surgery? Am J Sports Med. Cartilage. Barnes DA, Badger GJ, Yen YM, Micheli LJ, Kramer DE, Fadale PD, Hulstyn MJ, Owens BD; BEAR Trial Team; Flannery SW, Ecklund K, Sanborn RM, Costa MQ, Chrostek C, Proffen BL, Sant N, Murray MM, Fleming BC, Kiapour AM. The BEAR Implant was granted De Novo Approval from the U.S. Food and Drug Administration in December 2020. Patients must have an ACL stump of at least 1 cm attached to the tibia to facilitate the restoration. Historically, the repair method of just suturing the two ends together has not been very effective.". Whether it replaces ACL reconstruction as the gold standard remains to be seen but I am optimistic it will, Fleming adds. M.M.M. Clinical Research Progress of Internal Brace Ligament Augmentation Technique in Knee Ligament Injury Repair and Reconstruction: A Narrative Review. By Kristen Fischer Epub 2020 Jun 29. ________________________________________________________________. 2021 Feb 3;103 (3):e14. -, Akelman MR, Fadale PD, Hulstyn MJ, et al. The BEAR procedure is a promising technique that will likely meet these goals. Surgery can be tailored accordingly. How The BEAR Implant Works To Heal ACL Tears Paul Norio Morton, MD 2023-03-12T17:47:17-10:00 October 13, 2022 | Comments Off on How The BEAR Implant Works To Heal ACL Tears The Bridged Enhanced ACL Repair ( BEAR ) implant is the first medical advancement to enable your body to heal its own torn anterior cruciate ligament (ACL). 2014;42(7):1567-1573. doi:10.1177/0363546514530088. Meaning the cartilage destruction markers after an ACL reconstruction surgery are similar to those seen right after the original injury, causing a double hit to the cartilage. Randomized controlled trial; Level of evidence, 1. Disclaimer. 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. The advantages are: In past decade, we have published two MRI analysis case series demonstrating good healing of the ACL with the Perc-ACLR procedure (16,17). The study will continue to monitor knee stability and outcomes for 10 years following the procedure, with 9 post-operative visits taking place throughout the duration of . 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. We think you need to have sufficient ACL tissue left to repair for the surgery with the implant to work, Murray says. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. official website and that any information you provide is encrypted First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. Epub 2010 Jun 16. Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair. Migliorini F, Vecchio G, Eschweiler J, Schneider SM, Hildebrand F, Maffulli N. J Orthop Traumatol. 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. Dec 16, 2020, 14:53 ET. (4) King JD, Rowland G, Villasante Tezanos AG, Warwick J, Kraus VB, Lattermann C, Jacobs CA. Osteoarthritis Cartilage. Based on what I have observed for MRI evidence of healing on the images shared by the company that makes the BEAR implant and physicians online trying this procedure, the ligament reconstitution is not complete until 12 months. Today, the U.S. Food and Drug Administration granted marketing authorizationunder the De Novo premarket review pathwayfor an anterior cruciate ligament (ACL) implant . 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. (3) Hunt ER, Jacobs CA, Conley CE, Ireland ML, Johnson DL, Lattermann C. Anterior cruciate ligament reconstruction reinitiates an inflammatory and chondrodegenerative process in the knee joint. Additional stitching holds the device in place. Complications observed in the study consisted of graft or repair failure and the need for additional surgical procedures. Thus, there remains a need to find a new method that is less invasive and has the potential to provide better outcomes. Given the promising results of the BEAR procedure in the BEAR I and BEAR II trials, two additional studies were approved by the FDA the BEAR III trial and the BEAR-MOON trial. A total of 74 patients with acute proximal isolated ACL tears will be assigned in a 1:1 allocation ratio to either (I) ACL repair using cortical button fixation and additional suture augmentation or (II) ACL reconstruction using an all-inside autologous hamstring graft technique. Upper left panel:, CONSORT (Consolidated Standards of Reporting, CONSORT (Consolidated Standards of Reporting Trials) diagram detailing patient flow through the study., MeSH Complications observed in the study consisted of graft or repair failure and the need for additional surgical procedures.
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