Earlier this summer, ValleyOrtho announced that Tomas Pevny, MD, was using a relatively new procedure that involved using an implant – trade name BEAR (Bridge-Enhanced ACL Restoration) – to repair torn anterior cruciate ligaments (ACL) in knees. ValleyOrtho, based at Valley View Hospital (VVH) in Glenwood Springs, also has branch clinics in Aspen, Willits, Eagle and Silt. Pevny has been an orthopedic surgeon since 1995; he is the only physician at ValleyOrtho using the procedure.
In a VVH press release, the procedure was described as “the first disruptive technology in ACL tear treatment in more than 30 years.” It continued, “Transforming how this common, mountain community injury is addressed, the BEAR Implant enables a torn ACL to heal and restores the natural function of the knee.”
In a conversation with The Sopris Sun, Pevny explained that “disruptive” in this case referred to the fact that the BEAR procedure allows surgeons to repair torn ACLs rather than reconstructing them, as, he said, has been the “gold standard” up until now. He noted that previously, an attempt to repair a torn ACL (rather than reconstruct it) was “pretty much a disaster,” which made surgeons “skeptical” of attempting it.
Thus, until the advent of the BEAR Implant, surgeons would replace the damaged ligament. As Pevny described it, that would involve obtaining tissue (a section of quad, patellar or hamstring tendon) from a “harvest site” on the patient’s leg and grafting it into the knee joint. This meant more invasive surgery, more discomfort (since two wounds had to heal), longer rehabilitation time and more pain than the new procedure.
The press release described the BEAR Implant as “a bovine collagen-based sponge that bridges the torn ends of the ACL and promotes healing.” It continued, “Surgeons inject a small amount of the patient’s own blood into the implant before positioning it between the ACL’s torn ends. The combination of the implant and the patient’s own biological healing factors allows the ligament to regenerate naturally while preserving its original attachments to the femur and tibia. Over time, the implant is absorbed by the body.”
The implant was approved by the FDA in late 2020, but Pevny decided to wait until there were published studies on its efficacy. After those became available and showed that the implant “did very well,” he began using the procedure “about a year-and-and-a-half ago.” Noting that the BEAR Implant “acts like a scaffolding” between the two damaged sections of the ACL, Pevny said that “the healing rate is much better” and that “we’ve been able to repair ACL tears that we couldn’t in the past.”
Initially, the BEAR Implant was approved only for complete ACL tears and was available only for adults and children as young as 14 whose bone growth was largely complete. Pevny said, “My cutoff was 25,” adding, “Historically, the ideal patient is someone in their 30s to 50s.” However, in May this year, the FDA approved the implant for partial tears as well as for children as young as six months old.
The new approval holds great promise for partial tears of the ACL. Until now, as the press release stated, normal treatment options were “limited to physical therapy, bracing or full ACL reconstruction.” It continued, “The BEAR Implant provides a ligament-preserving surgical option that stabilizes the knee while retaining the remaining healthy ACL tissue.”
Even more promising is the effect the expanded approval is expected to have on pediatric ACL treatment. As Dr. Sean Keyes, a pediatric orthopedic surgeon at AdventHealth for Children, described in a MedPath article earlier this year, “Surgery to fix an ACL disease tear is different in children because we are concerned about causing damage to the growth plates, which can lead to issues such as limb length discrepancies and angular deformities. The BEAR Implant allows us to restore the ACL to its original, natural state while preserving the growth plates.”
While acknowledging the potential impact for younger patients, Pevny said that he was again waiting for the results of clinical studies before performing the procedure on them. He stated, “If the results are good or better than reconstructive surgery, I’ll do it.”
Author’s note: Dr. Pevny was the subject of an October 2023 article on his pioneering use of iovera⸰, a cryoanalgesia device, in knee-replacement surgery. Asked about it recently, he said, “It’s been a game-changer” that he uses in every procedure.