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Possible New ACL Repair Method

post #1 of 10
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post #2 of 10


Good to know they have started human trials.  I remember reading about the idea a while ago.  Looking forward to the results of the randomized trials to compare the sponge procedure to current ACLr surgery using a harvested ligament.

 

In the experimental technique, the surgeons placed a blood-soaked sponge between the ligament’s severed ends; the sponge acted as a bridge, helping the ligament grow back together over the next six to eight weeks.

It was the first time the technique had been tried in humans.

No participants in either group had ligaments that failed to reconnect, got an infection or had stiff knees.

Only the first patient — Corey Peak, 26 — has passed the one-year mark since the experimental procedure. The other patients had it done a roughly six months.

post #3 of 10

Looked around for more info.  Turns out that a Phase 2 randomized clinical trial has started that will recruit 100 patients to compare the new procedure to current ACL reconstruction surgery.

 

The procedure is called BEAR for Bridge-Enhanced ACL Repair. Dr. Martha Murray has been working on the idea for quite a while.  Unlike ACL reconstruction surgery that requires harvesting a substitute ligament, BEAR is an actual repair of the existing injured ACL.

 

 

The procedure is described pretty clearly on the Boston Children's Hospital website:

 

 

The first patient to be treated with BEAR ruptured his ACL while skiing. Since he was a grad student in Boston, he found out about the research and decided to join the trial. The surgery was three weeks after injury.  He wrote about his experience about a year after surgery.

 

ACL repair: What it’s like to be first to have a new surgery​

 

 
 
 
post #4 of 10

The video in the blog entry by the first patient to ever have the BEAR procedure done includes MRI pictures taken three months after surgery.  The study was approved by the FDA in Fall 2014 and includes 20 patients, 10 who did BEAR and 10 who were treated with the current standard ACL reconstruction surgery.  By March 2016, all 10 BEAR patients have had 3-month MRI pictures taken and all show signs of the ACL healing in place.  No wonder Dr. Murray and her team are excited.

 

The target patient population that Dr. Murray is most focused on are teens and young adults.  The increasing number of ACL tears in that population is pretty staggering.  She started working on the idea in 1989.  Teens and young adults stand to lose the most if ACLr surgery fails for whatever reason or if the reconstructed ACL is ruptured in another sporting accident.  Apparently that happens around 20% of the time in young athletes.

 

I think that young folks playing on a sports team are likely to be diagnosed quickly when there is a knee injury.  My guess is that BEAR is most effective when surgery is done quickly.  For the Phase 1 trial, the protocol was to do BEAR within a month of injury.  The first surgery was done three weeks after the skiing accident.

 

 

post #5 of 10

Very cool.  Always great to see breakthroughs, especially since ACL reconstruction has had very little progress in multiple decades.

 

Interesting to hear about long term prognosis and possibly expanding this technique onto other ligaments should this deemed to be successful for the ACL.

post #6 of 10

There was a story about this in the Boston Globe today.  I was amused to note that it appeared in the Sports section.

post #7 of 10
Quote:
Originally Posted by mdf View Post
 

There was a story about this in the Boston Globe today.  I was amused to note that it appeared in the Sports section.


Assuming it was the same article that I linked that was online on 3/23, could be in Sports because the focus for the Phase I study is on younger adults who are avid recreational athletes.  For the clinical trials, surgery must be performed within 30 days of injury.  I assume a lot of teens and young adults playing on sports teams get diagnosed fairly quickly if there is any suspicion of an ACL injury.  The hope is that the post-op recovery time will be 6-9 months, which is a few months shorter than after ACL reconstruction surgery.  Obviously for someone on a sports team, a few months could make a huge difference in that means they can be fully recovered before the next season starts.

 

"To be eligible for Phase 1, Murray required that patients be 18-35 years old, with a bottom ligament stump 6-8 millimeters to ensure a solid attachment to the sponge. Additionally, they couldn’t have extensive damage to the knee besides an ACL tear or be more than 30 days out from the injury. 

It took only eight months to fill all 20 slots in the safety study — 10 who opted for the BEAR procedure and 10 in a control group who underwent tendon-graft reconstructions. The average age of participants was 24, and Micheli described them all as avid recreational athletes."

post #8 of 10

The surgeon who is did all the Phase I surgeries for both the BEAR and the ACLr patients has been innovative for a long time.  He figured out how to help a toddler born without an ACL over 30 years ago who was too young for ACL reconstruction surgery that requires drilling holes in bones.  The man moved to Colorado about 15 years ago so he could ski more.  At the end of a 2015 article Dr. Micheli talked about the work being done with the sponge bridge idea.

 

So far it works in animals — and works better in younger animals, Micheli said. It's expected to work better in younger human patients — high school and college-age athletes.

"If it works in humans," Micheli said, "it will be revolutionary."

http://www.denverpost.com/news/ci_27978466/denver-man-born-without-acl-inspired-bold-revolution

post #9 of 10

INTERESTING. Yes, I agree that there is "stuff" where the torn ACL was, and that it could very likely represent healing tissue. One of the later images in the video, apparently of a different patient, has "stuff" that more closely resembles what a native ACL looks like on MRI.  Seems to be very promising.

post #10 of 10
Quote:
Originally Posted by cosmoliu View Post
 

INTERESTING. Yes, I agree that there is "stuff" where the torn ACL was, and that it could very likely represent healing tissue. One of the later images in the video, apparently of a different patient, has "stuff" that more closely resembles what a native ACL looks like on MRI.  Seems to be very promising.


The way I understand the video, all the MRI images starting at about the 4:00 mark are of the first patient, Cory Peak, at 3 months after surgery.  The reason for the press coverage this week is that now all 10 of the BEAR patients have passed the 3 month time point and their MRIs all show healing in progress.  Since it's a Phase I safety study, I would expect there to be follow up for these patients will have follow up for quite a few years.

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