May 15, 2018 Ligamys, Canadian Research Ethics Board, bear trial

2am

Reply from my DIS ligamys inquiry arrives, still 21 days, so not an option.  Also received 5 more published papers on its results.

8am

I receive a reply from Canadian Research Ethics Board from my efforts to get an application in for BEAR Trial.

10:42am

I send the DIS published research to my Sports Medicine doctor at AKIC University of Calgary in preparation for my appointment 10am tomorrow.  Is it strange to expect someone would be interested in their field of expertise?

11:09am

BEAR explains they are confused that I’m trying to both introduce their device to Canada, as well as be a patient. 

12:27pm

I email BEAR again, and tell them I’m trying to both introduce their device to Canada, as well as be a patient.

3:07pm

BEAR trial let’s me know they won’t help even if I move to meet their 3 hour criteria.  Still no criteria provided for me to pass on to my friend in the US.

I never ended up receiving a link from BEAR Trial to their 3rd trial criteria which I asked for several times to forward to a US friend. 

I learn in addition to hospital funding, grant funding from the NFL (NFLPA player study harvard)  was a significant factor in making BEAR trials possible.  Curious if they are offering this to NFL players when they get injured.

8:52pm

I send the ultrasound to The Mackay Clinic, and inquire about my shortening timeline to avoid ACL attenuation, or other potential options to avoid removal if unnecessary.  And maple syrup.

Found more info on internalbrace primary repair #surgical technique here:

https://www.arthrex.com/what-surgeons-are-talking-about/131FD01B-7B44-491D-B5F7-015A9474A65E

Despite the situation, I still had awesome #ski season, including the day this happened – even though this happened it was still a great day!

knee Brace May 1-4, 2018

While all this has been going on, I haven’t missed a day of work & continue adapting to function.  There’s a noticeable difference in the way people look at me with a disability – in public I find they spend more time looking at me, perhaps trying to figure what’s different.  Perhaps we all blend in until a disability is visible which catches people’s attention and they try to figure it out.  One benefit is this will deepen my empathy.

People have also been helpful opening doors when they notice this which I’m thankful for. 

May 1, 2018

While on the call, the doctor recommended I wear a brace for this injury – which I think is funny, as apparently I haven’t needed one for the last 45 days since it happened I’ve been waiting for diagnosis.  He recommends getting one at Colman Prosthetics & Orthotics.  So I contact them and they say I need to provide them a prescription.

May 2, 2018

I call the doctor’s office and request he write a prescription for the knee brace he recommended.

May 3, 2018

I pick up the prescription from AKIC at the University of Calgary and drop it Colman Prosthetics

May 4, 2018

Get fitted for an Ossur GII Rehab knee brace.

Found these instructions online, hopefully they help someone:

A lot of running around over 4 days that would be quickly identified and addressed through lean healthcare, saving time for the patient, doctor & prosthetic supplier.  Let’s start

I also sent an inquiry to the BEAR Trial team on how this can be available in Canada (see pic).

They responded it is still in research phase, so I asked how to get it into research phase in Canada as well.

I followed this with a request for the BEAR III Trial criteria & details, as I learned the 100 BEAR Trial 2 outcomes were so strong a further round of 100 is proceeding with surgery to save ACLs.

BEAR trials ACL repair

I continued doing research on BEAR trial, including articles from ResearchGate, BEAR Trial 2 at Boston Childrens

Apparently an ACL tear is one of the most common types of knee injury, accounts for around 40% of all Sports Injuries.

Treatment can be surgical or conservative (which is reserved for sedentary patients).  Physically active patients seek surgical treatment to restore functional strength to the ligament.  The current standard surgery uses a graft made by stripping perfectly fine tendon tissue or ligament from elsewhere (hamstring, patella, etc.).  In addition to removing good tendon and having to recover from this in addition to the knee injury, I’m concerned from the high risk of early onset osteoarthritis in the injured knee from the standard surgery.

Rehabilitation from this takes 9 months to a year to regain the loss of quadricep strength and knee flexibility caused by having a portion of tendon removed.

From what I understand BEAR uses stitches and a bridging scaffold (a sponge injected with the patient’s blood) to stimulate healing of the torn ACL.  This maintains a clot that facilitates ACL regrowth by providing barrier from synovial fluid effects. 

Another way of saying it:

a suture repair to bridge the gap between torn ligament tends & incorporates a bioactive scaffold to promote self-repair.  The sponge is inserted into the area where the torn ACL once was, soaked in the patient's own blood and then attached to both torn ends of the damaged ACL. Over time, the sponge acts as a "bridge" and allows the ACL to reattach itself, thus re-growing a fully intact ligament.

The bovine scaffold acts as a bridge that lasts in the joint long enough to allow the ACL ends to heal back together. 

Patients then wear a restrictive hip-to-ankle post operative brace for 6 weeks, at which point they switch to another sports brace.

Recipients so far demonstrated faster recovery time than graft recipients, & hamstring strength at 3 months was significantly better in BEAR patients.

ACL regrowth BEAR trials (bridge assisted ACL Repair)

After first finding an ACL healed itself, the 2nd thing I found were the BEAR trials run Boston Childrens in these two articles from 2016:

http://www.stack.com/a/radical-new-surgery-allows-you-to-regrow-your-acl 2016 stackmedia

https://www.bostonglobe.com/sports/2016/03/23/new-surgery-could-revolutionize-knee-repairs/BJISuh60AYKYTKWPwaYFWP/story.html Boston Globe

A safety study had been done on 10 patients, all reported “doing well, with knees working as well as knees treated with ACL reconstruction.”  The 1st patient surgery was Feb. 2015 (> 3 yrs ago), for Corey Peak, who also tore it skiing.  He concluded that it was a better option to treat a torn ACL; within 3 months post-surgery, his MRI showed that his ACL had started to naturally knit together; he was jogging on a treadmill. Soon after, cycling to work. 

Bridge Enhanced ACL Repair - How it works:

When viewed under a microscope, ACLs still have active cells and blood vessels after injury.  The ligament itself works hard to heal, however the synovial fluid — the lubricating substance that exists inside of all joints —washes away the blood clot that serves as the initial connection between torn tissue ends in other parts of the body. 

Conventional treatment for an ACL tear involves removing the torn ends of the ligament that’s trying to heal itself, & fabricating another from a tendon graft, usually done by stripping away good tissue (hamstring or patella).  Patients who had 1 injury then have to recover from 2 separate injuries—the torn ligament + the uninjured area where the graft was taken out.

Whereas a traditional reconstructions involves removing good tissue for a graft from another part of the body to fabricate an ACL, BEAR allows patients to re-grow their own ACL. This resulted in both quicker #recovery and fewer long-term complications than the traditional ACL amputation & reconstruction.

An estimated 150,000 ACL tears still occur every year in the USA. “ACL re-tear rate can be as high as 20% for teens.  Up to 80% of patients develop arthritis 15-20 years after surgery.”

Given the eligibility criteria timeline, I need to figure this out fast, as I was at 38 days, and I didn’t want unnecessary ligament removal.