ADR Risks, Complications, Disqualifications

[Carson]

In reading above it was mentioned hypnosis was part of testing for trial qualification.

1. Is that unusual to anyone else?
2. Does anyone know the extent of the purpose for hypnosis in context of qualifying for an ADR trial?

[Harrison]

Carson, I am sorry -- I really have no idea what you are referring too. Can you be more specific?!

[Carson]

Originally Posted by KBear

A bit of a correction to Steve's post. I was told I could not have surgery due to pysch reasons. I was able to do bio-feedback and then got through (it had nothing to do with me switching doctors). I was supposed to do 5 sessions. I did 2 sessions (in which I was actually extremely relaxed when I got there, according to their testing). The man who did the bio-feedback switched jobs, so they didn't have someone to finish mine. I refused to do hypnosis because of religious beliefs (nothing against anyone who has done it or has had benefits from it, I just did not feel comfortable letting someone have 'control' or at the minimum 'strong power of suggestion' over my mind).
Kathy

Oh, I was referring to KBear's mention of hypnosis (above) earlier in this thread. I never would have conceived of hypnosis as part of the trial approval process. Is that common?

[nornie73]

Very informative, Harrison. Just a few picky clarifications:

Generally speaking: Inclusion and Exclusion Criteria have to do with candidates (i.e. subject/patients) during a clinical trial. This language is not found on post market labeling. These will usually morph into Indications and Contraindications. None of this language is anything remotely like enforceable Laws, since the FDA's scope really doesn't extend to the actual practice and art of medicine. Physicians are generally peer governed. FDA product labeling can be construed as advisement and informational regarding Pre-Market Approval (PMA) of the Investigational Device Exemption (IDE) trial experience.

[Harrison]

I just wanted to refresh this topic since Nornie offered some very helpful comments here -- thx Nornie! Hope you are your hubbie are doing well!

And yes, you got the "morphing" part right -- since most of us here are morphing experts by virtue of the fact that we are willing to be pioneers with this new technology.

Peace and good health to all of us in ALL the days to come!

[nornie73]

Harrison,

Thanks for the reply. Not meaning to be deceptive but...

Actually that was me, Bob. I just didn't want to start a new account for me, so I post on her login. Chances are her need for the board will become less as I recover. I however may have new things to add as I recover and learn more.

Stop reading here -- unless you are prepared for a huge tangent(s).


In a not too distant previous life I used to do clinical research and marketing for a couple of medical device start-ups (both acquired by big boys with names on the big board). Was an interesting experience. Was able to participate in many of the aspects of product development. From the research side I was able to take a novel product from drawing board, to prototype(s), to in-vitro, in-vivo, human investigational device exemption (the actual clinical trial), to PMA submission (pre-market approval involving submitting truckloads of paperwork and analysis), to market. I was amazed and in awe of how much work goes into getting a class III medical device to market.

Most people would be blown away if they knew how concerned medical device companies are about patient safety and product efficacy. America's FDA clearance is a very high hurdle, however I believe we hold ourselves to the highest standards of safety and efficacy in the world.

It seems as if Europe and the rest of the world gets the cool stuff way before the USA, which is in some ways true. They also get devices to market by a MUCH easier path, which makes it easier for unsafe and unproven product to get to market over there. Remember too, liability and medico-legal risk are VERY different animals outside of the US. Anyway, I blather, but all these things should be food for thought as one considers racing over to Germany, Spain, Italy, Great Britain, India or elsewhere (by the way I have been to hospitals in all these places) to have a Gee Whiz 9000 hammered into my spine.

Nuff said,

Bob

[jss]

Bob,

Outstanding insight, thanks for the tangent.

Originally Posted by nornie73

... but all these things should be food for thought as one considers racing over to Germany, Spain, Italy, Great Britain, India or elsewhere (by the way I have been to hospitals in all these places) to have a Gee Whiz 9000 hammered into my spine.

The ProDisc-L is the only disc I've read of that some surgeons install with a hammer. As you received a ProDisc-C, did Dr.Lauryssen also use a hammer to install the ProDisc?

Thanks, Jeff

[nornie73]

ISS,

Depends on how one defines hammer. Many Cervical discs are inserted with the help of a mallet: Pordisc C, Mobi C, Prestige and etc. That really wasn't my point however, I was using the term for dramatic effect. It is so easy to over interpret language outside of oral conversation. Nothing wrong with a mallet it is part and parcel of an orthopedic surgeon's or neurosurgeon's armamentarium.

Dr. Lauryssen uses the milling device to cut the channels for the device, but finds he often has to use the included chisel to get the channels deep enough in some individuals.

[jss]

I see.

Well, the confusion was on my side because I have seen a video in which a well known European surgeon is rejoicing in the new technique that he has developed to implant the ProDisc-L. He says, "We just hammer(s) it into the bone". The video shows him coming from shoulder height with what looks to be a three pound rubber mallet. I'd eyeball that he delivered about 35 ft/lbs of momentum to whatever tool he'd placed over the ProDisc. If I ever need a ProDisc-L, I'm NOT going to see this particular surgeon.

It almost sounded like Dr Lauryseen used that technique to implant your ProDisc-C. (I'm glad that he didn't) I'd post it if I had a way to get that video from a DVD to an .mpg file.

[Harrison]

This is a good summary article of lumbar artficial disc replacement for new community members. Note the particular "relative" contraindications!
__________________________________________________ ________

Lumbar Disc Arthroplasty

By: Kene T. Ugokwe, M.D.
Monday, November 15, 2010

Mechanical low back pain (LBP) continues to be a major cause of morbidity within the current population in this country and contributes approximately $34 billion in annual health care costs.

The etiology of mechanical LBP is multifactorial and may be as a result of degenerative changes with the disc spaces. It may sometimes be difficult to accurately diagnose and effectively treat.

Patients with mechanical LBP are first managed conservatively with therapies that may include epidural steroid injections, non-steroidal anti-inflammatory agents, oral narcotic medications and physical therapy to strengthen core muscles. If all the conservative measures are exhausted without any relief to the patient, surgical intervention is often recommended.

Surgical treatment of mechanical LBP has historically centered on fusion of the abnormal or dysfunctional spinal segment with subsequent loss of the motion segment. The rationale behind fusion is the fact that fusion eliminates painful, non-physiologic motion across the destabilized or degenerated segment. When the fusion includes the addition of interbody devices and spacers, normal disc space height may be restored while also preserving sagittal balance.

However, spinal fusion alters the normal biomechanics of the spine and transmits forces to adjacent vertebral levels which may lead to accelerated disc degeneration, facet arthropathy and osteophyte formation, all of which may cause recurrent back pain and symptomatic spinal stenosis at levels adjacent to the fusion site.

This has lead to the development and evolution of other treatment modalities for mechanical LBP leading to the advent of lumbar disc arthroplasty which in the popular vernacular is called the artificial disc. The concept behind lumbar disc arthroplasty is that it allows for pain relief by eliminating presumed pain generators including the annulus and nucleus while preserving motion thereby eliminating the development of adjacent segment disease.

Lumbar disc arthroplasty can be divided into total disc replacement (TDR) and partial disc replacement (PDR) which is also known as nucleus replacement. Lumbar artificial disc technology restores the normal anatomy and preserves physiologic motion rather than eliminating it as fusion does. A degenerated disc leads to an abnormal joint which is unable to completely support the weight of the body thereby causing pain with motion. Fusion of the joint eliminates the abnormal motion thereby relieving the pain. The artificial lumbar disc preserves motion, restores disc height, lumbar lordosis and restores the normal instantaneous axis of rotation without exerting undue stress on the adjacent segments.

In order to place an artificial disc, the degenerated disc is completely removed. This eliminates the risk of any further disc herniation which hopefully retards spondylosis, stenosis and instability. Placement of the artificial disc restores anatomical disc height and prevents exiting nerve root compression at the dynamically stabilized level.

Good candidates for artificial lumbar discs are young patients with single level disc disease and non-osteoporotic bone without instability and facet arthropathy. Since disc replacements only provide anterior column reconstruction, patients with significant posterior disease are not good candidates.

Indications for disc replacement may include the following:

• Degenerative disc disease with loss of disc height and dehydration
• Extensive Modic changes of the disc space
• Intensive annular pathology including high intensity zones and annular disruption
• Degenerative disc disease with annular pathology including disc fragment extrusion or containment within the annulus
• Degenerative disc disease or acute disc space collapse after previous microdiscectomy using facet saving techniques.

Relative contraindications for artificial lumbar disc include:

• Multilevel pathology with indeterminate source of pain
• Lumbar scoliosis with apical degenerative disc disease
• Translational instability syndromes including spondylolisthesis and spondylolysis
• Previous infection, tumor or vertebral body dimorphism
• Presence of stenosis and subarticular disease and severe facet joint pathology
• Persistent epidural fibrosis.
• Patients with a body mass index greater than or equal to 34 should be counseled extensively to try and achieve a body mass index less than 30 prior to implantation.

Artificial joints are not a new concept in orthopedics as demonstrated by the various widely available artificial hip and knee joints. As technology continually improves, similar success may be encountered in lumbar disc arthroplasty.

Dr. Kene T. Ugokwe is a spine fellowship trained neurosurgeon at St. Elizabeth Health Center in Youngstown, Ohio.