BEAR® Implant Surgery Can Be Performed Days, Weeks or Months After ACL Injury
Over 3,000 patients have received the BEAR® Implant since it was approved by the U.S. Food and Drug Administration (FDA). These patients from across the U.S. have experienced the benefits of naturally healing the ACL and restoring the function of the knee, instead of replacing it with a graft in an ACL reconstruction (ACLR).
While during the clinical trials and initial product release patients were required to have surgery within 50 days of injury, commercial experience has shown ACL tissue quality, not time, determines eligibility for the BEAR implant.
Read on for insights on the impact of ACL tissue quality on BEAR Implant surgery, as well as stories of three patients who received the implant after 50 days.
Clinical Trial Requirements Were Different
Clinical trials that supported product approval by the FDA used the 50-day eligibility window. As with any clinical trial, it was important to control variables, so ensuring surgery be performed within 50 days of injury aimed to remove tissue quality as a variable to outcomes.
In the BEAR I study, which assessed the safety and early efficacy of the BEAR Implant to repair an ACL in comparison to ACLR, patients treated with the BEAR Implant had similar clinical, functional and patient-reported outcomes to ACLR. In the pivotal BEAR II study, patients who received the BEAR Implant had similar ACL healing outcomes and superior hamstring muscle strength in comparison to ACLR.
Learn more about clinical study results.
Tissue Quality Determines BEAR Implant Eligibility
In real-world use, there is not a strict timeframe for when BEAR Implant surgery must be performed. Eligibility for BEAR Implant surgery is based on one thing: the quality of the remaining tissue as assessed by an orthopedic surgeon. Earlier may be better because ACL tissue quality degrades over time, but the timing of this process is different for everyone. Therefore, assessing the ACL tissue quality is more important than adhering to a specific window of time.
“We often think about the time from injury in consideration for BEAR ACL repair,” said Dr. Shawn Anthony of Mount Sinai Orthopedics. “While sooner is certainly better, what really matters is what the quality of that remaining ACL stump tissue is at the time of surgery. We have patients who are over 50 days from their time of injury who still have excellent and very repairable ACL stump tissue.” Learn more from Dr. Anthony about who is a candidate for BEAR Implant surgery.
A Quarter of Patients Have Surgery After 50 Days
Since approval by the FDA in 2020, approximately 25% of patients have received the BEAR Implant past 50 days. Here are some of their stories:
Deirdra Milord, 58 days post ACL tear
Deirdra, 16, tore her ACL her sophomore year of high school during a soccer game when her foot got stuck in a hole on the field. She received the BEAR Implant 58 days after her injury and returned to playing soccer nine months post-surgery.
“This school year, I’ve been able to return to playing J.V. and varsity soccer at my school, and I’m continuing to build my strength and mobility,” Deirdra said 14 months after surgery. “I look forward to the potential of playing competitively in college in a couple more years.”
Curtis Karwacki, 3 months post ACL tear
Curtis, 32, tore his ACL while sparring with an opponent during a jiu jitsu class. He received the BEAR Implant three months after his injury and returned to jiu jitsu one year post-surgery.
“I am living proof that the BEAR Implant works, and I am able to do everything I used to prior to my injury,” said Curtis 17 months after surgery. “I feel supremely confident in my knee and am continuing to make progress in my physical health journey.”
Susan Bertrand, 10 months post ACL tear
Susan, 59, tore her ACL during a fall while downhill skiing on a family trip to Vermont. She received the BEAR Implant 10 months after her injury and returned to yoga and hiking nine months post-surgery.
“At my age, patients typically either live with the pain after an ACL injury or opt for ACLR,” said Susan 17 months after surgery. “I believe in the healing power our bodies have and am grateful the BEAR Implant allowed me to naturally regrow my own ACL. I have full confidence in my knee, and I don’t feel any restrictions from my body.”
Read more stories of BEAR Implant recipients who have returned to sport in the Comeback Community.
Learn more about the BEAR Implant and find a surgeon
The BEAR Implant is available across the U.S. Learn more about the BEAR Implant or find a surgeon in your area.
The BEAR Implant from Miach Orthopaedics was approved by the U.S. Food and Drug Administration in December 2020. It is indicated for adults, adolescents and children with a complete or partial rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair. Children with open physes must have sufficient bone in the femoral and tibial epiphyses on either side of the intended tunnel locations to avoid disruption of the growth plates.
It is important to follow the BEAR Implant physical therapy program. Your surgeon can explain the program details.
Be sure to discuss your individual symptoms, diagnosis and treatment with your surgeon. The BEAR Implant has the same potential medical/surgical complications as other orthopedic surgical procedures, including ACL reconstruction. These include the risk of re-tear, infection, knee pain, meniscus injury and limited range of motion.
Visit www.miachortho.com for complete product information, including Instructions for Use.
ML-1174 Rev A 06/2024