Biostat Biologx Fibrin Sealant for Degenerative Discs

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n37fef
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September 15, 2012 at 6:10 am

Post count: 1

#6945

I hope all is well with you in Vail. I am one of your patients that you performed a discetomy at L5-S1 back in December of 2009. I am doing pretty good and doing my core exercises, cardio and started light lifting. I still have some pain in both legs and feet but it is manageable most the time.

Last month I stumbled across a You Tube video about the Biostat Biologx Fibrin Sealant on CBS Sunday Morning. The video is about an FDA clinical trial NCT01011816 – Biostate System Drug – 11/9/2009. The creator is Dr. Kevin Paulza of the Texas Spine and Joint Clinic in Tyler, TX.

The clinical participants can not have prior surgery for herniated discs.

What is your opinion on this and how far away is it from being approved by the FDA? What other advancements can we look forward to with biologics or regenerative medicine with stem cells for disc issues?

Donald Corenman, MD, DC
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September 16, 2012 at 9:49 pm

Post count: 8660

#6956

One of the biggest problems with biologics and the disc is that the disc is avascular (has no blood supply). I have treated patients that have had previous stem cell injections into the disc with no good results. I think the reason for failure is that there has to be a good blood supply to the structure injected with stem cells and the avascular disc will not support new cells that are implanted.

That reasoning continues with this fibrin sealant. I have treated patients who have had platelet gel (PRP or platelet rich plasma) injected into the disc without good results. I understand that the contents of this injection are similar to PRP so I have a difficult time understanding how this is going to be different.

I would love to believe that we now have a new treatment for the disc that can be performed by injection but I have been in the spine field for 35 years. I have seen many “new and improved” treatments come and then go (cage rage, IDETT, PRP, nuceloplasty, chymopapain, dynamic stabilization). All the past new treatments were brought in with much press and fanfare and all left without any notice. The only real new breakthrough in the last 10 years has been BMP (bone morphogenic protein) and that was only for fusion of the spine.

We will have to see if this new injection has any promise. The good news is that it should not be injurious to the disc so there should be minimal downside (except for the injection itself) if it does not work.

Dr. Corenman

PLEASE REMEMBER, THIS FORUM IS MEANT TO PROVIDE GENERAL INFORMATION ON SPINE ANATOMY, CONDITIONS AND TREATMENTS. TO GET AN ACCURATE DIAGNOSIS, YOU MUST VISIT A QUALIFIED PROFESSIONAL IN PERSON.

Donald Corenman, MD, DC is a highly-regarded spine surgeon, considered an expert in the area of neck and back pain. Trained as both a Medical Doctor and Doctor of Chiropractic, Dr. Corenman earned academic appointments as Clinical Assistant Professor and Assistant Professor of Orthopaedic Surgery at the University of Colorado Health Sciences Center, and his research on spine surgery and rehabilitation has resulted in the publication of multiple peer-reviewed articles and two books.
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Donald Corenman, MD, DC

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81 reviews

Eric S

Sep 26, 2021

by Eric S on Donald Corenman, MD, DC

Successful pars repair at 46 years old

Back in November of 2018 (at 46 years old) I came from Vancouver BC to have a pars repair done with Dr. Donald Corenman at the Steadman Clinic in Vail Colorado. I'm finally posting this review nearly three years later in late 2021. The reason I waited so long was I wanted to know the final result before I posted my review. Unfortunately in that time Dr. Corenman has retired. Nevertheless, I want to post this review of Dr. Corenman and his staff at the Steadman Clinic in their excellent treatment of my L5 pars interarticularis.

I fractured my pars at age 42 back in 2014 when rolling on the gym floor, and was denied treatment by the Canadian healthcare system, probably due to my age. First my GP told me there was no surgical option for a pars defect, which was quite incorrect! I tried to live with it, but the symptoms worsened (periodic random spine slippage and weeks of resultant pain after just bending over to tie my shoe, so I eventually learned to mostly squat and hardly bend). When I finally consulted with Canadian spine surgeons, I was told they believed my pars defect had been congenital (since birth). This was absurd, considering I had done extreme martial arts (including jiu jitsu) for years prior, as well as 5 years of reinforcing steel full time in my 20s, probably the hardest job on the back you can find. No pars defect like mine would possibly have allowed this--ergo it was impossible that I had had the defect since birth. I did however have an asymptomatic congenital spina bifida occulta that made me more susceptible to a pars fracture. In 2014 in one instant, I went from having the strongest back people I knew said they'd ever seen, to being unable to safely bend over and tie my shoe without a non-negligible risk of my spine slipping randomly (which would lead to weeks of pain after each occurrence). This was due to the unilateral L5 pars defect, otherwise known as spondylolysis. It was when lying in pain on the floor 4 years later after maybe the 6th spine slippage event post injury, that I had had enough, and resolved to have surgery. If Canada's "universal health care" said no, I would make lemonade from lemons, and find the very best surgeon in the world at pars repairs. That was Dr. Donald Corenman. Dr. Corenman back in 2018 ran a website https://neckandback.com/ that dedicated many pages to the science of every aspect of pars repairs, from eligibility (good discs on MRI), to best surgical techniques (minimal open compared to minimally invasive), best imaging to use (i.e., O-Arm with Stealth imaging vs. older fluoroscopy), the ideal amount of BMP to use and why not use too much or too little, and much more, all to do with pars repairs, pages upon pages of his site just on the pars, with scientific references and his own extensive expert opinion. As a health research statistician, I was very impressed with this. It was in stark contrast to the websites of other spine surgeons which barely gave the pars a word or two, focusing almost exclusively on fusions. I had found the best surgeon in the world for pars repairs, and so after Dr. Corenman personally screened my MRI to ensure my discs were healthy, I booked the surgery.

Being 46 years old at the time of surgery in 2018, with a 4-year-old pars fracture from 2014 combined with a congenital SBO meant my pars fragment was somewhat atrophied, but it was "very solid", said Dr. Corenman in the operative report. Nevertheless, it was challenging with two things to fix, the pars and SBO, and OR time was around 4 hours. Recovery over the following months was guided by a very clear "Spine binder" from the Steadman Clinic with strict rules of "no BLT" (no bending, lifting or twisting), and illustrated physiotherapy guidelines. They even warned patients to avoid fish oil supplements, which could excessively dampen inflammation and hence slow bone healing. They answered many questions I had during months of recovery, with responses coming from the very supportive Lori Fugate (then director of Dr. Corenman's practice), and Ehrich Bean (then physician's assistant at the practice), as well as a couple calls with Dr. Corenman himself after two of the CT scans. Ehrich Bean offered great advice for taking the spine binder conservatively due to the nature of pars repairs vs. fusions. The final post-op CT scan I had was a couple weeks ago at 34 months post-op, and Dr. Corenman had retired, but I got a very positive and informative call from Eric Strauch (current PA at the Steadman Clinic under Dr. Corenman's replacement there, and who had also worked with Dr. Corenman previously). The staff at the Steadman Clinic were extremely supportive all the way through the process. I should mention, the local Canadian spine surgeon did offer me very good post-operative support including antibiotics as needed to deal with a mild surface incision-site infection early on, booking numerous x-rays when I felt something was amiss, as well as booking all four of my post-op CT scans. I am very grateful for that support also.

My final result shows plenty of solid bone across the pars and a healed SBO, with my vertebral body now a solid bone ring instead of being broken at two places as it was pre-op. Does my spine hold up in the real world? You bet! I have recently dug and moved several yards of dirt and sand and gravel by myself (shovel and wheelbarrow!) to fix our water main, pulled roots from the yard, moved several "portable" (these are HUGE) air conditioners up several flights of stairs my myself, and lifted weights. I now run 2 miles (3.2 KM) several times weekly with a hard 100 meter dash in the middle. I bend deeply before each run I go on, with no spine slippage. My spine feels amazing. I can bend over to do exercise, or real word tasks, with no risk of spine slippage.

My sincere thanks to God, Dr. Donald Corenman, Lori Fugate, Ehrich Bean, Eric Strauch, and the Steadman Clinic, as well as the Canadian spine surgeon who offered me excellent post-operative care back in Canada. You have all given me a new lease on life.

Sincerely,
Eric S

Robert S

May 11, 2021

by Robert S on Donald Corenman, MD, DC

Back Fusion Surgery

I had my entire lumbar spine fused in November of 2018. I had scoliosis , with pinched nerves that were so painful I could hardly walk - and standing for more than a few minutes was impossible. Even sitting was painful.
The fusion surgery produced immediate relief! And the recovery was much easier than I expected.
To this day I can do all the activities I love from hiking, to standing in a stream fly fishing to riding my bike long distances - or just walking down the street with my wife.
Kudos to Dr. Corenman and his staff, (including the two Erics) for taking such good care of me!

Leslie R

Jul 9, 2020

by Leslie R on Donald Corenman, MD, DC

TLIF

I had my TLIF surgery on 6/24/2020 by Dr. Corenman, I can not say enough good things about the Dr or his staff. I was always treated with respect and explained everything throughly, that made it easy for everyone to understand. I highly recommend Dr. Corenman and the Steadman Clinic.

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