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Promising new ACL repair concept in clinic trials

Post #4 includes a video about the first patient to undergo BEAR. The young man tore his ACL while skiing during the 2015-16 season.

The repair surgery includes adding a special blood-soaked sponge as a "scaffold" to help the ligament heal naturally. Normally the synovial fluid inside the knee prevents blood from staying around during the healing process. The ACL is the only ligament completely inside the knee. This repair process works best on younger patients based on research in animal models. Younger patients are at higher risk for failure when ACL reconstruction surgery is performed. The Phase 2 trial recruited patients ages 18-35.

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Angel Diva
While the results of the BEAR trial based in Boston won't be known for a while longer, there are other surgical approaches being used successfully in Europe to repair torn or fully ruptured ACLs in both children and adults. The following link is for an article on the website for the Knee Preservation Foundation based at Univ. of Winchester, UK that was established Feb 2016 by Dr. Adrian Wilson, one of the innovators actively doing and promoting ACL repair surgery. It provides a brief history of ACL repair treatment starting in the 1970s.

Why Does Adult ACL Repair work now when it didn't before?

In addition to the Internal Brace Method that's been used by Dr. Wilson and Prof. Mackay (Glasgow) for about five years, there is a repair process called Ligamys (TM) that seems to be based in Switzerland but has centers all over Europe. In general repair surgery must be done relatively soon after an ACL injury, usually within a few months. That means early diagnosis using an MRI is important, which can be an issue in some situations.

Could Innovations in Ligament Preservation Techniques Bring Personalised Medicine to ACL Treatment?

Ligamys: Preservation of the ACL
"Dynamic intraligamentary stabilisation (DIS) represents an alternative treatment method for ruptures of the anterior cruciate ligament. The affected knee joint is dynamically stabilised by the Ligamys implant: A polyethylene thread that is anchored in the femur and tibia follows the natural course of the anterior cruciate ligament and temporarily takes over its function. In doing so, the spring system in the monobloc enables the dynamics needed for movements. The stumps of the anterior cruciate ligament are approximated and can heal, protected by the Ligamys implant.
In contrast to the methods described above, the Ligamys implant offers the patient the possibility of preserving the natural cruciate ligament."
The 2-year followup is complete for the BEAR Phase I patients. The official report was prepared for a conference in March 2019. Note that the target population for Bear is younger patients because the ability to heal is much better than for older patients. Those patients who participate in sports in high school and college at an elite level are an important group given the high rates of ACL rupture.

Boston Children's Hospital announces results of Bridge-Enhanced® ACL repair study
The first-in-human study shows BEAR® procedure has similar outcomes to traditional reconstruction

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"At 24 months, nine of the ten repaired subjects and seven of the ten reconstructed patients completed a study visit," says Lyle Micheli, director of the Boston Children's Division of Sports Medicine and lead surgeon on the trial. "There were no graft or repair failures and recovery was similar for both groups, providing us with encouraging outcomes and an exciting road ahead."
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There is a little more info on the Boston Children's Hospital website about the ongoing research for BEAR. A third study that has already enrolled patients expanded the age range to include patients well over 35. Animal studies showed better results for younger subjects who obviously heal faster.


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Promising early results for new ACL surgery

In an article in the Orthopaedic Journal of Sports Medicine and in a presentation at the Arthroscopy Association of North America (AANA)/American Orthopaedic Society for Sports Medicine (AOSSM) 2019 Specialty Day, we reported the 24-month results of our phase I, FDA-approved, first-in-human study assessing the safety and early efficacy of the BEAR procedure.

The study, led by orthopedic surgeons Martha Murray, MD, and Lyle Micheli, MD, began in 2015. Of the 20 patients who participated, 10 underwent the BEAR procedure and 10 received standard ACL reconstruction. All of the subjects were between the ages of 18 and 35. Nine of the 10 subjects who received BEAR surgery and 7 of the 10 subjects who received traditional ACL reconstruction completed a 24-month study visit, which included an MRI.

The two groups had similar clinical, functional, and patient-reported outcomes, with significant gains over baseline preoperative values. At 24 months, all 9 patients in the BEAR group exhibited continuous tissue in the region of the ACL. Similarly, the ACL grafts were intact in all 7 patients in the ACL reconstruction group who returned for follow-up, with no gap between the proximal and distal limbs. The only difference between the two groups at 6, 12, and 24 months after surgery was significantly greater return of hamstring strength in the BEAR group.

ACL Study | Safety first

This phase I study was the culmination of 15 years of laboratory work developing a safe and effective scaffold. In unrelated studies conducted at other research centers, 20 percent of subjects had a serious inflammatory response to other extracellular matrix patches. With this in mind, we designed our phase I study with a small sample size to screen for problems that might occur in a larger study. Happily, none of the subjects who received a BEAR implant developed an infection or severe inflammatory reaction, arthrofibrosis, or reaction that required scaffold removal.

We are now conducting a randomized, blinded trial with 100 patients to compare the outcomes of the BEAR procedure with those of standard ACL reconstruction. We started enrolling patients in May 2016 and completed enrollment in June 2017. We have implanted more than 100 BEAR scaffolds with no sign of infection. We expect that two-year follow up data will be available later this year.

A third study, BEAR III, has enrolled 49 subjects at two sites, Boston Children’s and Rhode Island Hospital. We have expanded the age range of this study to include patients between 12 and 80 years old. We anticipate enrollment for the BEAR-MOON study, a five-site multicenter study led by Kurt Spindler, MD, of the Cleveland Clinic, will begin later this year.

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