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  #1  
Old 12-28-2008, 09:11 PM
Harrison's Avatar
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Exclamation ADR Risks, Complications, Disqualifications

Everyone,

What follows is a brief description of risks, complications and possible disqualification criteria for artificial disc replacement. It is by no means a comprehensive list. Please note:

1. this is for informational purposes only; use it to frame questions with your doctor(s) and future research;
2. it is focused on lumbar ADR, but many conditions may apply to cervical ADR;
3. the contraindications may vary considerably, based on a number of factors, including (partial list):
a) the device manufacturer’s FDA approval guidelines
b) the particular clinical trial’s design parameters
c) interpretive differences between doctors
d) domestic vs. international medical interpretations, laws, business (sales & mktg) practices
e) time between patient’s imaging studies; e.g. their change in physical condition
I’ll be iterating this post to improve it’s readability and comprehensiveness in the coming weeks. Given the questions and posts from the past months, I thought it would be smart to post this now.
__________________________________________________ ___________________

Surgery Risks and Complications: Lumbar ADR
Regarding possible complications from ADR surgery, there’s a lot to consider – so think about these possible surgical risks and talk to your doctor.

Possible Complications May Include:
  • Unresolved or new pain
  • New, unexplained symptoms
  • Reactions to anesthesia
  • Paralysis
  • Death
Mechanical Problems May Include:
  • Incorrect placement of the device into the vertebral body
  • Implants breaking, loosening, or moving
  • Abnormal stresses on facets joints and adjacent structures
Immunological Problems May Include:
  • Allergic reaction to device wear debris
  • Wound, device, skin or systemic infections
  • Infection introduced by intubation
  • Progression of undiagnosed disease at other levels
  • Blood transfusion risks
Neurological Problems May Include:
  • Injury to nerves causing sexual dysfunction
  • Nerve damage to urologic structures
  • Scar tissue accumulation on nerves
Vascular Problems May Include:
  • Blood flow restrictions, hematoma or stroke
  • Excessive blood loss
  • Injury to major blood vessels
ADR Contraindications (Exclusion Criteria):
  • Back or leg pain of unknown origin;
  • Previous major spinal surgery at affected level;
  • Abnormal abdominal vessel or fascial pathology or morphology;
  • Degenerative spondylolisthesis with greater than 3 mm slippage;
  • Isthmic (spondylolytic) spondylolisthesis;
  • Spondylitis (i.e., inflammation of the spine);
  • Significant spinal, foraminal or lateral stenosis;
  • Extensive facet arthritis or degeneration of the facets;
  • Scoliosis of the lumbar spine with greater than 11° coronal deformity;
  • Localized, metabolic or systemic bone disease;
  • Localized or systemic osteoporosis
  • Active, systemic infection;
  • Active malignancy or history of metastatic malignancy;
  • Any immunological disease which might impair healing;
  • Use of any drug known to interfere with bone or soft tissue healing;
  • Known metal allergy;
  • Morbid obesity (BMI >40 or more than 100 pounds overweight);
  • Transitional vertebrae at level to be treated that has not clearly fused;
  • Pregnancy
_________________________


May 27, 2009 Update

The following information was derived from the original FDA studies based on the Charite’ clinical trial. It was excerpted by an insurance provider and is now over five years old. As this information may have changed or evolved, use it carefully to frame questions for your doctors.
___________________________________________

Indications for properly selected patients for ADR were provided by the FDA and include the following:

§ Skeletally mature individuals with degenerative disc disease at one level (either L4-L5 or L5-S1);
§ Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies;
§ There should be no more than 3 mm of spondylolisthesis at the involved level;
§ The patient should have failed at least six months of conservative treatment prior to implantation of the artificial disc.

In addition to the above FDA indications, the following criteria are commonly found in the literature and are recommended:

§ Age 18 to 60 years;
§ Degenerative disc disease defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies with one or more of the following factors:
1. Contained herniated nucleus pulposus;
2. Paucity of facet joint degeneration changes;
3. Decrease of intervertebral disc height of at least 4 mm; and/or
4. Scarring thickening of annulus fibrosis with osteophytes indicating osteoarthritis.
§ Radiographic studies (usually computed tomography or magnetic resonance imaging) supporting the diagnosis of degenerative disc disease. Findings include vacuum disc sign, high-intensity zone signal, Modic changes, degenerative cyst formation, and marginal vertebral body osteophyte formation;
§ Discogram performed by an independent radiologist or anesthesiologist demonstrating concordant pain reproduction and that includes at least one control level that was not painful and did not reproduce the patient’s symptoms;
§ Nonradicular leg pain or back pain in the absence of nerve root compression (i.e., pain resulting from disc herniation) as determined by MRI or CT without lateral recess stenosis. (The only exception is that in carefully selected cases neuroforaminal stenosis could be corrected by the artificial disc restoring the intervertebral disc height and increasing the neuroforaminal height);
§ Oswestry Disability Index score of more than 30;
§ Visual analog Scale (VAS) score of greater than 40 (of 100) assessing pain.

Contraindications or exclusion criteria generally include:

§ Previous attempted lumbar fusion procedure anywhere in the thoracolumbar spine;
§ Patients with bone abnormality such as osteoporosis or osteopenia;
§ Objective evidence of nerve root compression;
§ Straight leg raise producing pain below the knee;
§ Spinal fracture, spondylolysis, spondylolisthesis, scoliosis, spinal tumor, or severe facet joint arthrosis;
§ Patient being more than one standard deviation greater than normal body weight;
§ Patient with significant psychosocial symptoms;
§ Patients who have had prior discectomy, IDET, or chemonucleolysis may be appropriate for artificial disc replacement if there is no leg pain below the knee and enough of the posterior facets are present to prevent overdistraction of the facet joints.
__________________
"Harrison" - info (at) adrsupport.org
Fell on my ***winter 2003, Canceled fusion April 6 2004
Reborn June 25th, 2004, L5-S1 ADR Charite in Boston
Founder & moderator of ADRSupport - 2004
Founder Arthroplasty Patient Foundation a 501(c)(3) - 2006
Creator & producer, Why Am I Still Sick? - 2012
Donate www.arthropatient.org/about/donate
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  #2  
Old 01-04-2009, 02:47 PM
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I had a partial discectomy at l4/l5 in 2007. Does that mean they can't replace this disc? If so,why? thank you Phyllis
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  #3  
Old 01-04-2009, 03:07 PM
mango
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Post Why?

Hi

Why go through it
Death was a major red flag for me,I understand all major surgery have risk.
Thanks for the information.
What is the longest ADR result in a patient, I have found it to be about five years.
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  #4  
Old 01-04-2009, 04:01 PM
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The Charite ADR has been in use in Europe for better than 22 years.
__________________
Laura - L5S1 Charitee
C5/6 and 6/7 Prodisc C
Facet problems L4-S1
Knee, Shoulder, Toe, Finger, Elbow Problems

Jim - no spine problem but lots of other fun medical challenges

"There are many Annapurnas in the lives of men" Maurice Herzog
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  #5  
Old 01-05-2009, 02:53 AM
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Default answers

RadkeNY,

I don't believe a prior disectomy will prevent you from getting your disc replaced. Other factors like osteoporosis and spondylolisthesis (vertebrae slipping over each other) and severe facet arthritis most likely will disqualify people from getting ADR. The surgeon will do what he/she is trained for or comfortable with so some will recommend fusion because that is what they know. Also in Europe, I believe the docs have done more advanced surgeries like three level ADR and hybrids which haven't been done here as much.

Mango--Why go through ADR?
Well for me, I weighed the pros and cons of the surgery and decided ADR was better for me than fusion. Plus the surgeon I trusted was recommending ADR vs. fusion. ADR was started in 1989 (I think. I forget the dates and am too tired to look it up, but google it and you will find the info of when they were started here) in the United States in trials. More than 20 years ago in Europe.
IMHO, the best thing is to be well-informed about any procedures available to you. The surgery is major and should only be undertaken if you need it. I was in severe pain and I was practically begging for surgery and I am pretty surgery adverse.

Good luck and happy decision making,

Kimmers
__________________
hurt back lifting, herniated disc at L4/L5. DDD
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  #6  
Old 01-05-2009, 03:01 PM
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Default More educated now

Mango,
Now that I know a little more, I realize that if you have to fuse the bottom disc L5-S1, you will not lose that much movement. It is the ones above that are so much more critical for movement. I would also worry about adjacent segment problems if you fuse but each procedure has a consequence. Death rarely happens but you do have to think about it. Sometimes pain is like death too. This post may not help and we have to trust the doctor that does the procedure and feel confident in his ability.
RadkeNY,
I agree with Kimmer"s post.
Phylly
__________________
Cervical fusion C4-C6 2002
Fall on tailbone April 2005
Discogram concordant at L4-S1 2007 for back pain not leg pain
Prodisc ADR surgery L4-L5-S1 November 2007
Decompression surgery L4-S1 for left sided sciatica July 2008
Continued back and leg pain, looking at possible fusion
Removal of Prodiscs and L4-S1 fusion February 2009
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  #7  
Old 01-05-2009, 07:46 PM
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Quote:
Originally Posted by phylly View Post
Now that I know a little more, I realize that if you have to fuse the bottom disc L5-S1, you will not lose that much movement.
I recognize that I'm in a losing battle here but this statement is an opinion that has never been proven nor does it make any sense if you look at the mechanics of any simple structure. The degree of motion in L5-S1 isn't the only determiner of how much trouble you'd be in if you fused it, look at the loads across the segment as well.
__________________
Laura - L5S1 Charitee
C5/6 and 6/7 Prodisc C
Facet problems L4-S1
Knee, Shoulder, Toe, Finger, Elbow Problems

Jim - no spine problem but lots of other fun medical challenges

"There are many Annapurnas in the lives of men" Maurice Herzog
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  #8  
Old 01-05-2009, 11:40 PM
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Quote:
Originally Posted by annapurna View Post
I recognize that I'm in a losing battle here but this statement is an opinion that has never been proven nor does it make any sense if you look at the mechanics of any simple structure. The degree of motion in L5-S1 isn't the only determiner of how much trouble you'd be in if you fused it, look at the loads across the segment as well.
Why not a hybrid surgery? I am by no means an expert on ADR, barely a rookie. But, from what I have read, it seems like people who have ADR on S1-L5 and L4-L5 end up with 'too much motion' that can cause problems. I think I possibly read this in a clinical study (retrospective one I think), and/or a spine article. Plus, there are some on here with problems that had ADR on L4-L5 and L5-S1. If it were me, I would have a hybrid, if I had the problems with those 2 levels. Any other 2 levels, I would have 2 ADR's. Disclaimer: I'm not stating any of this as fact, just my personal opinion; which I know that some will disagree with me and some will agree and a lot just won't care
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  #9  
Old 01-06-2009, 07:28 AM
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Hybrid would work. Heck, there's people that need to fuse L5-S1 and an ADR at that level would leave them in worse shape. I'm protesting the notion that L5-S1 has little motion so it can be fused without consequence.
__________________
Laura - L5S1 Charitee
C5/6 and 6/7 Prodisc C
Facet problems L4-S1
Knee, Shoulder, Toe, Finger, Elbow Problems

Jim - no spine problem but lots of other fun medical challenges

"There are many Annapurnas in the lives of men" Maurice Herzog
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  #10  
Old 01-12-2009, 07:10 AM
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Posts: 127
Default Left out another Contraindiction for ADR surgery

Failing the doctor's Psyche tests!!! Myself and Kbear were told by the TBI Psyche dept that we weren't candidates for ADR surgery and we were made to believe that denial for surgery was going to be a likely result. But Kbear ended up making it past them in the end due to a new doctor being assigned to her case who overlooked that. My TBI psyche doctor told me that they will often deny patients ADR surgery due to Psyche reasons.
__________________
------------------------------
4/08- DDD at C5/6 & C6/7 & bulging discs. C5/6 portrusion.

6/08- Disco results- C6/7 painful, C5/6 popping sounds

7/08- Plasma disc decompression-significant relief obtained

11/08- pain returned to almost pre surgical levels

1/09 -Disco w/ Dr Ziglar shows C5/6 & C6/7 painful-2 level ADR recommended

2/26/09 - c4-c7 ADR Prodisc Nova with Dr Bertagnoli. 100% Success but need C6/7
ADR revision due to subsidence.
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