Knee Surg Sports Traumatol Arthrosc. 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. 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. However, as shown above, just like an ACL reconstruction, the BEAR implant surgery still has the physician drill tunnels. Epub 2023 Apr 13. (7) Bczkowicz D, Skomudek A. BEAR and the Regenexx Perc-ACLR procedure are better than an ACLR surgery in many ways. Am J Sports Med. Hamstring strength asymmetry at 3 years after anterior cruciate ligament reconstruction alters knee mechanics during gait and jogging. Anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow nucleated cells: a case series. Tissue Eng Part A. Scand J Med Sci Sports. The BEAR-MOON trial is enrolling 200 English-speaking individuals nationwide who: Our team of board-certified orthopedic sports medicine surgeons and researchers specializes in arthroscopic repair of sports-related injuries including complex knee reconstructions. The preliminary work is very promising, but with any new research, we need more data to confirm the early findings, Lepley says. 2016;44(7):16601670. Fleming says the FDA approval was exciting news that provides a treatment alternative to ACL reconstruction that does not require removing the injured ligament and replacing it with a graft of tendon.. BEAR-MOON is an acronym for BEAR (Bridge-Enhanced ACL Restoration) MOON (Multicenter Orthopaedic Outcomes Network). Harvard Health Publishing. B.L.P. Fourth, there is no need to take a tendon graft with BEAR, so things like hamstrings and quadriceps weakness are avoided. There are four primary goals to ACL repair using the BEAR Implant: Provide a stable knee. 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. PMC Epub 2014 Mar 20. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. It is recommended that the BEAR device be implanted within 50 days of injury. Measurements below 3 millimeters (mm) are considered normal. It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Epub 2016 May 13. We hypothesized that female sex would have significantly worse early functional outcomes and higher retear rates following primary repair of the ACL enhanced with a tissue-engineered scaffold . Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. The https:// ensures that you are connecting to the 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. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. Although ACL reconstruction is effective, the procedure has drawbacks; the . Before sharing sensitive information, make sure you're on a federal government site. 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. Thats the Regenexx Perc-ACLR procedure (Percutaneous ACL Repair). AR065462 and R01AR056834). Her work has appeared in outlets like Healthline, Prevention, and HealthDay. -, Ageberg E, Roos HP, Silbernagel KG, Thomee R, Roos EM. There were no graft or repair failures in the first 24 months after surgery. 2 absorbable sutures attached to it is passed through the femoral tunnel and engaged on the proximal femoral cortex. 2023 Feb;51(2):413-421. doi: 10.1177/03635465221142323. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. . Results: is a founder, paid consultant, and equity holder in Miach Orthopaedics, Inc, which was formed to work on upscaling production of the BEAR scaffold. The primary objective of the BEAR I trial was to show that there would be no major complications (i.e., inflammation, infection, or rejection) in patients who received the implant. Patients report more satisfaction in terms of pain, symptoms, and readiness. Epub 2020 Apr 16. ACL reconstruction surgery has been a staple of modern sports medicine for decades. 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. Patients must have an ACL stump attached to the tibia to construct the repair. The Lifespan Orthopedics Institute is managing the only New England . 2017;45(1):97105. Lower right panel: The sutures and extracortical buttons are secured. 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. On the other hand, those in the control group had a laxity in the treated knee of 1.77 mm. "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. Its a multi-center, randomized, clinical trial seeking adult participants with a torn ACL that has occurred within the past 50 days, who qualify for surgery. 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. Before The site is secure. 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.". Hence, any implant procedure requiring tunnels to be drilled will likely harm cartilage. If the latter holds true in clinical patients, then the impact of the BEAR procedure will be even greater.. Methods: 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. ________________________________________________________________. Am J Sports Med. Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament 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). A small percentage of patients treated with the BEAR Implant re-tore their ACL when they returned to sports sooner than recommended and then had a standard ACL reconstruction. 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. 2022 Oct 31;10(10):23259671221132564. doi: 10.1177/23259671221132564. Please enable it to take advantage of the complete set of features! Patients received physical therapy and were followed for two years. eCollection 2019 Mar. The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. Migliorini F, Vecchio G, Eschweiler J, Schneider SM, Hildebrand F, Maffulli N. J Orthop Traumatol. The BEAR Implant is the first medical advancement to enable your body to heal its own torn anterior cruciate ligament (ACL). In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. 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. Epub 2013 Aug 18. Its an absorbable implant thats derived from bovine collagena naturally occurring protein present in the connective tissue. L.J.M. Why? The experts explain how BEAR technology works and answer the most common questions about ACL injury and repair. This is a bovine collagen implant inserted in the torn area of the ACL with sutures placed in graft tunnels. Patients must have an ACL stump attached to the tibia to construct the repair. That tendon is secured in the tunnels and now serves as a replacement ligament. AOSSM checks author disclosures against the Open Payments Database (OPD). Most of these injuries happen to non-professional athletes. The bodys own tissue eventually replaces the implant. 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. The Football Players Health Study is funded by a grant from the National Football League (NFL) Players Association. One or more of the authors has declared the following potential conflict of interest or source of funding: This study received funding support from the Translational Research Program at Boston Childrens Hospital, the Childrens Hospital Orthopaedic Surgery Foundation, the Childrens Hospital Sports Medicine Foundation, the Football Players Health Study at Harvard University, and the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases through grants R01-AR065462 and R01-AR056834. First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. February 2022. doi:10.1177/23259671211070542. Knee Surg Sports Traumatol Arthrosc. Bridge-enhanced ACL repair (BEAR) is a new FDA-approved procedure that allows a torn ACL to heal itself and does not require graft tissue to be taken from another part of the body. 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 . Upper right panel: After a cortical button carrying free sutures (green) is passed up through the femoral tunnel, the BEAR implant is loaded onto them and soaked with up to 10 mL of autologous blood. Adam S. Lepley, PhD, co-director of the Michigan Performance Research Laboratory at the University of Michigan, who specializes in rehabilitation, noted that traditional ACL reconstruction focuses on rebuilding the ligament while the implant centers on repairing it. 2013 Dec;20(6):532-6. doi: 10.1016/j.knee.2013.07.008. She said it had the potential to change the standard of care.. 2019 Sep;53(18):1168-1173. doi: 10.1136/bjsports-2018-100167. PMID: 32298131; PMCID: PMC7227128. Benefits of BEAR ACL Repair in Pediatric Patients. Clinical Research Progress of Internal Brace Ligament Augmentation Technique in Knee Ligament Injury Repair and Reconstruction: A Narrative Review. Bio Ortho J Vol 3(1):e29e39; October 5, 2021. Propensity for Clinically Meaningful Improvement and Surgical Failure After Anterior Cruciate Ligament Repair. *DISCLAIMER: Like all medical procedures, Regenexx Procedures have a success and failure rate. 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. Epub 2013 Aug 19. 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. Finally, the research on BEAR has shown a lower likelihood of tearing the ACL in the opposite knee, likely because the natural biomechanics are likely better preserved than ACLR surgery. Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. Businesswire. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. A doctor has to weigh which patients would be an ideal candidate to receive the implant over traditional ACL reconstruction. Background: This study assessed the safety of the newly developed bridge-enhanced anterior cruciate ligament (ACL) repair (BEAR), which involves suture repair of the ligament combined with a bioactive scaffold to bridge the gap between the torn ligament ends. The ACL implant isnt a traditional device like those used in most joint repairs. Key Takeaways. Keywords: 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. BEAR resulted in noninferior patient-reported outcomes and AP knee laxity and superior hamstring muscle strength when compared with autograft ACLR at 2-year follow-up in a young and active cohort. 2017;45:97-105. Kristen Fischer is a journalist who has covered health news for more than a decade. Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the body's own tissue. (14) Nomura Y, Kuramochi R, Fukubayashi T. Evaluation of hamstring muscle strength and morphology after anterior cruciate ligament reconstruction. Orthop J Sports Med. This study is designed to evaluate bridge-enhanced ACL restoration (BEAR), a new surgical technique for repairing knees injured by a tear of the anterior cruciate ligament (ACL) that promotes reattachment and healing of the ACL using a blood-enriched implant. (15) Centeno C, Lucas M, Stemoer I, Dodson E. IMAGE-GUIDED INJECTION OF ANTERIOR CRUCIATE LIGAMENT TEARS WITH AUTOLOGOUS BONE MARROW CONCENTRATE AND PLATELETS: MIDTERM ANALYSIS FROM A RANDOMIZED CONTROLLED TRIAL. 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. Third, while it's unknown if knees repaired with BEAR retain their position sense, that's much more likely than the tendon graft . Third, while its unknown if knees repaired with BEAR retain their position sense, thats much more likely than the tendon graft placed by ACLR surgery. has equity interests in and is a consultant for MIACH Orthopaedics, a company that has licensed the BEAR scaffolding technology from Boston Childrens Hospital, which is also an equity holder in MIACH Orthopaedics; has patents/patents pending for the BEAR technology from Boston Childrens Hospital and Rhode Island Hospital; has received payment for grant review from the Musculoskeletal Transplant Foundation; receives royalties from Springer; and has research grants from the NIH, the Department of Defense, and the NFL Players Association through the Football Players Health Study. Accessibility J Orthop Res. PMID: 26261424; PMCID: PMC4527573. J Transl Med. 2016 Sep;32(9):1887-904. doi: 10.1016/j.arthro.2016.03.008. J Pain Res. 2014;42(5):1049-1057. doi:10.1177/0363546514526139. 2009;17(2):162169. The BEAR device must be implanted within 50 days of injury. PMID: 23959965. Her discoveries led to the conceptualization of an implant that could be placed between the torn ends of the ACL to bridge the gap, which is then mixed with the patients own blood to stimulate healing. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDAs 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. That may be tough to do using an MRI report, as the reading radiologist often doesnt differentiate between the two tear types. The BEAR Implant is a resorbable implantmeaning it is absorbed by the bodymade from bovine collagen and is secured via suture to bridge the gap between the torn ends of a patients ACL. ACL (anterior cruciate ligament) injuries. 33,34 The scaffold is used to bridge the . During surgery, the patients own blood is injected into the implant to form a device-protected clot that enables the body to heal. 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. By clicking Accept All Cookies, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. Unauthorized use of these marks is strictly prohibited. government site. Fleming says research is ongoing at Boston Children's Hospital, University Orthopedics, and Rhode Island Hospital to determine if there are specific patients that may do particularly well or may not do as well following the BEAR procedure. Perhaps the single biggest question from an athlete is, When can I return to play? For ACL surgery, the current recommendations are 1-2 years. Am J Sports Med. Conclusion: Despite this, the young and active population that BEAR was tested had excellent outcomes that were at least as similar as those receiving ACL reconstruction.. Updated December 16, 2020. Disclaimer. The BEAR Implant is indicated for skeletallymature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. 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. The BEAR group had a significantly higher mean hamstring muscle strength index than the ACLR group at 2 years (98.2% vs 63.2%; P < .001). M.M.M. Epub 2010 Jun 16. By Kristen Fischer 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. Study design: Hamstring strength indices were significantly higher in the BEAR group compared with the ACLR group (P = .0001). (2) Culvenor AG, Eckstein F, Wirth W, Lohmander LS, Frobell R. Loss of patellofemoral cartilage thickness over 5 years following ACL injury depends on the initial treatment strategy: results from the KANON trial. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA Authorizes Marketing of New Implant to Repair a Torn ACL, Office of Orthopedic Devices, Office of Product Evaluation and Quality. Patients with the implant had an average that was greater by 1.61 mm in the treated knee compared to their untreated knee. Am J Sports Med. Miach Orthopaedics' Bridge-Enhanced ACL Repair (BEAR) Implant has received marketing approval for the treatment of anterior cruciate ligament tears. Epub 2019 Feb 8. Orthop J Sports Med. In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. 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. Bethesda, MD 20894, Web Policies One or more of the authors has declared the following potential conflict of interest or source of funding: This work was funded by the Translational Research Program at Boston Childrens Hospital, the Childrens Orthopaedic Surgery Foundation, the Childrens Sports Medicine Foundation, and the National Institutes of Health (NIH)/National Institute of Arthritis and Musculoskeletal and Skin Diseases (grant Nos. The BEAR Implant was granted De Novo Approval from the U.S. Food and Drug Administration in December 2020. 2021 Apr;29(4):518-526. doi: 10.1016/j.joca.2021.01.004. Disclaimer. However, now a new surgical implant called BEAR is shaking up that world by offering a solution to try to regrow the torn ACL. 2015;43:121-127. 2023 Apr 12;11(4):23259671221146815. doi: 10.1177/23259671221146815. Would you like email updates of new search results? PMID: 23962647. 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. Mansour J, Ghanimeh J, Ghoul A, Estephan M, Khoury A, Daher M. SICOT J. 2023;9:8. doi: 10.1051/sicotj/2023007. This is a potential problem as the natural ACL has two bands that cross each other (hence the name Cruciate, which in Latin means cross). The .gov means its official.Federal government websites often end in .gov or .mil. Before 2015 Jun;25(3):301-7. doi: 10.1111/sms.12205. During that time, we have observed that younger patients are ready to return to sports at four months, with older patients at six months. Age, graft size, and Tegner activity level as predictors of failure in anterior cruciate ligament reconstruction with hamstring autograft. 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. Am J Sports Med. Epub 2013 Jun 28. Zhang Y, Xu C, Dong S, Shen P, Su W, Zhao J. Arthroscopy. Other patients showed higher signal intensity within the graft itself (eg, bottom row [third from left]), reflecting increased fluid within the graft. How is BEAR different than ACLR surgery? sharing sensitive information, make sure youre on a federal Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair. (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. all have disclosures as listed in the American Academy of Orthopaedic Surgeons database, none of which are related to this current project or technology. The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study. PMID: 33549723. The request was submitted under section 513(f)(2) of the FD&C Act. PMID: 23813800. Regenexx Perc-ACLR has been performed since 2012. ACL tears are often treated with surgery called ACL reconstruction. Tian S, Wang B, Liu L, Wang Y, Ha C, Li Q, Yang X, Sun K. Am J Sports Med. Bethesda, MD 20894, Web Policies Hypothesis: We hypothesized that patients treated with BEAR would have a noninferior . The IKDC subjective scores in both groups improved significantly from baseline (P < .0001) at 12 and 24 months, to 84.6 17.2 in the ACLR group and to 91.7 11.7 in the BEAR group. What if the anterior cruciate ligament (ACL) had the ability to repair itself? However, given that BEAR is a new technology, most surgeons are unlikely to allow a return to sports at six months. The BEAR Implant from Miach Orthopaedics was approved by the U.S. Food and Drug Administration in December 2020. Registration: 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. This site needs JavaScript to work properly. Murray also believes the implant will be a new gold standard for ACL repair in the future. 2023 Dotdash Media, Inc. All rights reserved, Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Patients were randomly assigned to receive either BEAR (n = 65) or autograft ACLR (n = 35 [33 with quadrupled semitendinosus-gracilis and 2 with bone-patellar tendon-bone]). PMID: 32558951. Commonly, they occur in a non-contact fashion with an acute twisting of the knee. Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. The upshot? That would be a shame, as its exposing the patient to more risk than is required to get good clinical results. 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.
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