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Promising new ACL repair concept in clinic trials

marzNC

Angel Diva
#1
The ACL repair surgery based on a "sponge" to encourage the torn ends of a ruptured ACL to grow together moved forward successfully with a clinical trial in human volunteers. Interim results are very promising. The process is called BEAR for Bridge-Enhanced ACL Repair. Dr. Martha Murray has been working on the idea for quite a while. A randomized clinical trial with 100 patients to compare BEAR with ACL reconstruction surgery is underway. Unlike ACL reconstruction surgery that requires harvesting a substitute ligament, BEAR is an actual repair of the existing injured ACL.

The first patient to be treated with BEAR ruptured his ACL while skiing. Since he was a grad student in Boston, he was lucky to find out about the research and be picked for the procedure. He wrote about his experience here.

3/23/16 update report
https://www.bostonglobe.com/sports/...nee-repairs/BJISuh60AYKYTKWPwaYFWP/story.html

The procedure is described pretty clearly on the Boston Children's Hospital website:
http://www.childrenshospital.org/centers-and-services/anterior-cruciate-ligament-program
 

Pequenita

Ski Diva Extraordinaire
#3
Makes sense. From age 16 to 29, I skied/played soccer/etc with a partially torn ACL, without a knee brace after the first couple of years. I pretty much operated under the theory that the ligament had hypertrophied. Ligaments don't get a ton of blood supply, but it seems like especially for younger patients, a bridge makes sense.
 

marzNC

Angel Diva
#4
Turns out that the video in the blog entry by the first patient to ever have the BEAR procedure done contains a lot of information not in the news articles I've found so far. There are MRI pictures taken three months after surgery. The study was approved by the FDA in October 2014, the trial opened in Feb 2015 for 20 patients, 10 who for BEAR and 10 who were to be 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 wanted to share the news.

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 over twenty-five years ago. 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. The video includes the moment she viewed the first patient's MRI for the first time. Pretty understandable that she had a pretty emotional reaction.

 

altagirl

Moderator
Staff member
#5
Makes sense. From age 16 to 29, I skied/played soccer/etc with a partially torn ACL, without a knee brace after the first couple of years. I pretty much operated under the theory that the ligament had hypertrophied. Ligaments don't get a ton of blood supply, but it seems like especially for younger patients, a bridge makes sense.
I had the relatively unique opportunity to see pictures of my allograft ACL about 18 months after it was done (had to go back in for meniscus surgery) and there were blood vessels that had grown all over it. It was really neat to see, because the before pics were this ghostly white ragged looking tendon when it was first put in, and then later it was smoothed out and looking very much alive. I was probably 30 at the time.
 

marzNC

Angel Diva
#6
Found an article from 2015 where it was noted that in animal studies the procedure worked better in younger animals. The expectation is that BEAR will work better in younger humans as well. For the Phase I study, they restricted patients to ages 18-35 and surgery had to be done within 30 days of injury. They are recruiting 100 patients for the Phase II study. One reason to publicize the positive interim results for Phase I is to make it easier to recruit patients for the next study. Although not too likely there will be many skiing injuries near Boston in the next few months given how few slopes are still open.
 

ski diva

Administrator
Staff member
#7
I was reading this thread about ACL surgery -- something I know a lot Divas have gone through -- and it brought to mind the following video about bridge-enhanced ACL Repair, which is currently undergoing trials. Wouldn't this be a great alternative? Hope it becomes readily available soon.

 

marzNC

Angel Diva
#8
The next clinical trial using BEAR is recruiting patients. Looking for up to 100 patients ages 14-35 (closed growth plates) with a complete ACL tear that's very recent (within 30 days). Patients will be randomly assigned to BEAR (2/3 of patients enrolled) or ACL reconstruction (1/3). All surgeries will be done at Boston Children's Hospital. Patients will not be told which procedure was done until two years after surgery. Follow up will continue for 10 years.

For more info: BEAR Trial Brochure
 

marzNC

Angel Diva
#9
A June article noted that all 10 Phase I patients who had BEAR are over six months from surgery. Apparently part of the funding comes from the NFL.

http://www.foxbusiness.com/features/2016/06/14/new-acl-procedure-game-changer-for-nfl.html

"Murray and her team are actively tracking the results of BEAR’s first human trial, which consisted of 10 patients who underwent the new procedure and 10 who underwent traditional ACL reconstruction surgery. As of this week, all trial patients are at least six months removed from surgery, while about half are a year removed.

So far, BEAR patients are back to full strength after about six months, compared to nine to 12 months for a traditional procedure. It’s too soon to say if human patients will show the same reduced incident of knee arthritis as the animal models, but researchers are optimistic. "
 

bounceswoosh

Ski Diva Extraordinaire
#11
Interesting. DH was all excited about this procedure "for your next ACL surgery." Uh, dude.

But if they're limiting it to 35 max in any case, if I ever do need another one, I'm sure it'll be the traditional route.
 

bounceswoosh

Ski Diva Extraordinaire
#13
"Thanks a lot, dear!"

How is he recovering, anyway?
Oh, he's doing great. He is still hobbling down stairs and walking slowly, but he's back to work (partly from home) and went out to eat yesterday (me, I couldn't deal with having my leg down long enough to eat dinner for over a month).
 
#14
Interesting. DH was all excited about this procedure "for your next ACL surgery." Uh, dude.

But if they're limiting it to 35 max in any case, if I ever do need another one, I'm sure it'll be the traditional route.
I seem to remember that in the early animal studies, the younger animals recovered much better. So the thinking is that younger humans will have greater success with the "sponge" procedure in self-repair of the ACL. There still is a long way to go before potential FDA approval for general use. Limiting the current trial to age 14-35 improves the changes for significant differences between the two groups. Patients are not being told which procedure was done for the initial period of recovery.

Another reason for emphasizing relatively young patients is that ACL reconstruction surgery is more complicated for them. Can't remember exactly why. Unfortunately more and more high school and younger kids are blowing out ACLs in non-contact sports like soccer, lacross, ultimate frisbee, etc.
 

bounceswoosh

Ski Diva Extraordinaire
#15
I seem to remember that in the early animal studies, the younger animals recovered much better. So the thinking is that younger humans will have greater success with the "sponge" procedure in self-repair of the ACL. There still is a long way to go before potential FDA approval for general use. Limiting the current trial to age 14-35 improves the changes for significant differences between the two groups. Patients are not being told which procedure was done for the initial period of recovery.

Another reason for emphasizing relatively young patients is that ACL reconstruction surgery is more complicated for them. Can't remember exactly why. Unfortunately more and more high school and younger kids are blowing out ACLs in non-contact sports like soccer, lacross, ultimate frisbee, etc.
Yeah, I wasn't complaining. Just observing. I am more annoyed about DH planning on me blowing out another ACL! Although he said it's because I'll be hucking cliffs and such .... so I guess that's all right ...
 
#16
Came across a journal article about the results of the Phase 1 trial for BEAR. It was a safety study but was designed to help design the first efficacy study that is currently looking for patients. Seems pretty clear that the 10 subjects who had the BEAR procedure all did well. The same surgeon did all the BEAR surgeries and the comparison ACL reconstruction surgeries.

The current study is recruiting 100 patients. More than half will have BEAR. It's actually a blind study in the sense that patients and the examiner looking at knee performance at predetermined time points will not know which surgery was done. Patients will be told after two years. It's going to be another year or so before all patients are enrolled.
 
#17
It remains possible that over-35s may have this option in the future. This is early days, just baby steps. I hope to put off ACL rupture until they have perfected it for the over-65s!

Or, somehow not tear it at all...!

I had a fairly routine hand surgery done for a broken pinkie metacarpal. Now, a year later, I can't complain but every day I know it's there. When someone notices me clenching my fist, I just tell them it's my PT. Clenching and stretching. Worse on damp days.
 

bounceswoosh

Ski Diva Extraordinaire
#18
I had a fairly routine hand surgery done for a broken pinkie metacarpal. Now, a year later, I can't complain but every day I know it's there. When someone notices me clenching my fist, I just tell them it's my PT. Clenching and stretching. Worse on damp days.
I had an avulsion fracture on my left middle finger years ago. An itty bitty little chip. Did all the hand therapy. Worked the crap out of it. It still can't straighten fully, so I can't really do the proper hand position for downward dog (ie, there shouldn't be a ton of pressure on the palms). So that results in more pressure on my wrists, which are tetchy ...

I'm only 39!!!
 
#19
I do think this means we shouldn't break bones or tear ligaments, at least after the age of . . . 6? 10? My daughter broke something in her hand when she was 7 or so, and no trouble at all. The bones were still growing, so I guess they took it in stride. Mine, not so much! Although I think the majority of my problem is from scar tissue. Many of us are familiar with this!
 
#20
The next clinical trial using BEAR is recruiting patients. Looking for up to 100 patients ages 14-35 (closed growth plates) with a complete ACL tear that's very recent (within 30 days). Patients will be randomly assigned to BEAR (2/3 of patients enrolled) or ACL reconstruction (1/3). All surgeries will be done at Boston Children's Hospital. Patients will not be told which procedure was done until two years after surgery. Follow up will continue for 10 years.

For more info: BEAR Trial Brochure
The Phase 2 trial for BEAR that is a randomized clinical trial that will include about 60 BEAR patients and long term monitoring completed enrollment in 2017.

https://skintobone.com/new-acl-surgery-bear/ - Sept. 18, 2017

" . . . 100 patients were enrolled for a randomized controlled trial. Two-thirds of the study participants will undergo the BEAR surgery, while the rest will undergo a traditional ACL reconstruction procedure. Their progress will be monitored over a 10-year period.
. . ."
 

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