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ACL reconstruction/repair without a graft? Bioscaffold repair

post #1 of 8
Thread Starter 

Whoa - how did we miss this?


A new technique to repair a torn ACL with a bioscaffold instead of a graft was approved for a 20 person human trial last November. The surgery must be done within 30 days of the injury. It will dramatically shorten the recovery time and reduce post injury arthritis. Huge props to Martha Murray (more info on that link). There were a couple of steps to go through in the trial before they actually tried the surgery on people, but we ought to be getting close to that step by now. Maybe in a few years this technique will become widespread and the word biosponge will enter our lexicon.


I can't find any fresher news.

She's written The ACL Handbook

Boston Globe Article

There was an article in Fast Company

post #2 of 8

Very interesting! The article in the Boston Globe is informative.  Dr. Murray was a grad student in engineering with an interest in materials science at Stanford before deciding to go into medicine.  The inspiration came from observing how a torn MCL can heal without medical intervention.  Given that the study approved in 2014 was only a safety study and not Phase I, it will take years before full FDA approval can happen, assuming all goes well.  First trials were in pigs.  First human study included 10 control patients doing ACL reconstruction and 10 patients doing the experimental procedure with a bioscaffold.  Having a repair option would be most helpful for children who are still growing, which makes ACL reconstruction surgery more complicated because bones must be drilled while they are still growing.


Haven't read it thoroughly yet, but this article in AAOS from Feb 2013 has a fair amount of info.


Award-Winning Research May Make ACL Healing Without Reconstruction Possible

post #3 of 8

Video is an explanation by Dr. Murray from March 2015 of the idea behind "bioenhanced ACL repair."  Basic idea came from observing what happens when a torn MCL heals without medical intervention.  The ACL is different because it's inside the knee and always in synovial fluid.


post #4 of 8
Thread Starter 

As best as I could tell, the 20 person human trial (10 real, 10 control) has been approved but has not gotten to the point where humans have had the surgery, The sponge device has to be approved  for human use before it can be used in the trial.

post #5 of 8

Well it's been a few years for me, so I guess I am out of luck here. 

post #6 of 8

The results of the Phase I trial for the BEAR "sponge" are quite promising.  The researchers in Boston are following 10 patients who were treated with BEAR, in comparison to 10 treated with traditional ACL reconstruction.  Also in the midst of recruiting for a Phase II trial that will include 100 patients who will be followed for 10 years.  Part of the funding comes from the NFL.




"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.  "

post #7 of 8

The first patient to have BEAR done wrote a blog entry that was posted in March 2016.  At three months, an MRI showed that the ACL was healing.


What's it's like to be the first to have a new surgery



post #8 of 8

I would imagine they are still recruiting patients for the Phase II trial that is based on randomly assigning participants to BEAR (2/3 of patients enrolled) or ACL reconstruction (1/3).  The trial began looking for patients in early 2016.  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.  They will close enrollment when there are 100 patients ages 14-35 with a complete ACL tear.  The tear must have happened within 30 days to be a potential subject in the study.  Young patients must have closed growth plates.


For more info:  BEAR Trial Brochure


The brochure include a simple comparison between the reconstruction and a repair using BEAR.


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