ANASTASIA’S       JOURNEY

  This is a living memoir to Anastasia Scott. She grew up in a small town of 800K people near Moscow. She loved her families picnic trips to woods, cross-country skiing …

1974 RUSSIA                 :  COLLEGE DEGREES: ACCOUNTING, COMPUTER TECHNOLOGY

1999 AMERICA             :  COLLEGE: BUSINESS BS. ACCOUNTING DIPL, COMP-SCI SR. , ELECTRONIC CAD DIPLOMA.

2005 GERMANY           :  FORCED TO WORK THROUGH PAIN DUE TO TRANSFER CONTRACT. NO MEDICAL HELP.

2005 JUN SURGERY 1  : MINIMALLY INVASIVE NUCLEOPLASTY DECOMPRESSION. FAILS TO REMOVE PROLAPSE

2005 SEP SURGERY 2  : MINIMALLY INVASIVE MICRODISCECTOMY WITH ABRASTION. FAILS TO REMOVE PROLAPSE

2006 JAN SURGERY 3  : ARTHROSCOPIC KNEE SURGERY TO CHECK MENISCUS.  NON-DISCUSSED PATELLA SHAVING

2006 OCT SURGERY 4 : PRODISC IMPLANTATION IN COLLAPSED DISC WITH ADVANCED FACET ARTHROSIS

2007 DR SEARCH:         : LOOKING FOR A SURGEON TO ANALYSIS AND TREAT THE DEVICE PROBLEM

2006 APRIL FOOLS      : ANALYTIC DISCOVERY OF NON-PHYSIOLOGIC PRODISC KINEMATICS

2007 OCT SURGERY 5 : PRODISC EXPLANTATION AND REVISION TO FUSION

1974: WELCOME TO RUSSIA!

Natalia (Mom), Anastasia 8 & Cousin Ana 4

Anastasia 8. Born  1974, Vladimir.

Anastasia and her Dad, Alexander

Anastasia & her Dad (Alexander), 2000 ?

Anastasia & Nephew Denis, 2001 ?

Anastasia first attended 2 colleges, obtaining diplomas in Accounting and Computer Technology. She worked in a hospital several years, before working as an accountant for a small distribution company.

1999: WELCOME TO AMERICA!

After moving to Tucson, Anastasia studied for two years to get a B.S. in Business. During this time she worked as a volunteer at the Y.M.C.A in Tucson. Simultaneously she completed a 2 year program (an Associate's Degree) in Accounting, from Pima Community College.Then studied Computer Science at the University of Arizona, advancing to a senior level on the Dean’s List, with a flair for Java. Bored with that, she then took up Computer Aided Design of Electronic Circuits (completed a 2 year program (an Associate's Degree in CAD IC Layout Design)  at the same Pima Community College. Which lead to job offers from National Semiconductor and Texas Instruments in Tucson.  She chose T.I. – and loved working with the really great guys there!  

Grandpa John (96 years old!) and his lovely flowers. We loved to take Grandpa to breakfast/lunch every Sunday morning.

Grandpa lived to 101, still walking, surfing (web), … and flirting.

Advanced Java Programming (Senior: Univ of Arizona).

Our Home: Between studying, landscaping, and enjoying Tucson’s café’s, bookstores, hiking, soccer, tennis … time really flew by.

Cabo San Lucas - 2001

Christmas by the fire, at home. 2003

Delayed Honeymoon-ish trip to Jamaica, Christmas, 2000

  Venice, September 2004 … two month’s left to live

Anastasia’s favorite place to study – circuit layout

Anastasia @ Texas Instruments, October 2004.

We sign contracts to transfer to Germany...

2005:  WILCOMMEN IN DEUTSCHLAND!

After our trip to Italy, we both were transferred from T.I. Tucson AZ to T.I. in Germany. Hey, what an opportunity! Paradise in the middle of Europe. Unfortunately, in the move, Anastasia pulled her back. Or, we thought she had only a minor radiculopathy. It took 2 days to get to Munich!  The disaster begins.  But … its not all disaster. Anastasia was in pain but still fully functional. It was very hard to give up our usual life style, i.e. outgoing adventure. In the first months we drove around nearest to our town German villages, taking in the beautiful scenery and amazing café’s.                       

"I didnt know that I will end up with 5 surgeries, lying down along in a small apartment, with no friends, no family. That I will be denied a medical treatment solely based on my USA citizenship. That I will be terminated by Texas Instruments while on disability....and much more".

 This place really could be a paradise … if your healthy.

MAR 2005 – WELCOME TO DDD HELL

Jan – Mar 14. Anastasia works in pain, on drugs.

German Doctors will not see her without a TKK Insurance card.

Anastasia can not quit work due to Transfer Contract (18 months).

MAR 14 2005. MRI’s show DDD in L4/5.

PROLAPSE IS APPARENT ON POSTERIOR. 

JUN 2005 –SURGERY #1.    FOLLOWED BY 3 MONTHS BED-RIDDEN

2 JUN 2005 MRI’s          SED: 12 JUN 2005              17 AUG 2005 MRI’s

Endoscopic Discectomy: 11.06.2005, Right side access.

 OBSERVATION: The procedure was not successful in removing the prolapse.

 (SED) creates 7mm hole in right side of disc to decompress nucleus-pulpusus

(Studies indicate that a puncture to the disc will initiate degenerative disc disease.).

SEP 2005 –SURGERY #2.    FOLLOWED BY 3 MONTHS BED-RIDDEN

SEP 22, 2005. MRI’s AlphaKlinik

PROLAPSE IS STILL APPARENT

Anastasia experiences ‘electroshock’ pain from an apparent new prolapse. She is taken by ambulance to the Alphaklinik, which is the only place we know of to handle the emergency.

NOTE. FACETS ARE FINE HERE

SURGERY #2:  DISCECTOMY + ABRASION. (here)

Surgery At AlphaKlinik

DEC 12, 2005 MRI’s. 

PROLAPSE NOT RESOLVED

JAN 2006 –SURGERY #3.    FOLLOWED BY 6 MONTHS BED-RIDDEN + KNEE TRAUMA

   After this last procedure Anastasia was unable to bend her knees beyond 90 degrees - and felt pain occasionally.

   Anastasia 'presented' to a AlphaKlinik in Munich (Dec 2005) after experiencing knee pain for several weeks. Recall, she had been bed-ridden for 6 months prior to presenting with the knee pain.  Thus, she was obviously weak.  This was never considered by the knee specialist. The Pre-Op document we have says surgery is Urgent.  Another document, the radiology report from a local doctor, says there is 'no sign of chondromalacia'.

     After visiting the AlphaKlinik several times, with the intent of seeing the primary surgeon, we were never able to see him. We saw an assistant doctor, who examined her and proscribed the Urgent surgery: a look at the meniscus. The assistant never mentioned the chondroplasty.

     The surgeon did a 'Shaving Chondroplasty' on her left patella.  video.   She was given instructions to keep weight off the knee for only 2 weeks.  It took 6 months before the inflammation had reduced enough to see definition to the knee. After 4 years, she is still unable to put weight on the knee-cap (she walks with a straight leg). The latest MRI's  indicate a chondral lesion. Doctors do tell us that the patella was absolutely fine, that the operation was totally unnecessary. They tell us this after I show them the MRI's and the images from the operation video.

        EXAMPLE: NORMAL                    EXAMPLE: GRADE III              ANASTASIA’S (NORMAL!!!).

-EVERY ORTHOPEDIC DOCTOR WE SEE SAYS THERE WAS NOTHING WRONG WITH THE PATELLA-

INDICATION   (All quoted from Dr. Toft)

#1 "Chondroplasty - can it prevent knee arthroplasty ?"

#2  for medial compartment osteoarthritis of the knee with near complete loss of the articular cartilage

#3  grade III chondral lesions that underwent shaving-chondroplasty will recover

#7 "the procedure is for the severely destroyed arthritic knee." - Toft, M.D.

#7 “If nothing is left of all that and you are faced with a situation of bone-on-bone, the second best solution is fibro cartilage,”

#17 If patellar cartilage deterioration proceeds beyond simple softening and involves fissuring, disintegration and/or outright erosion

#20 If your MRI indicates 2^nd to 3^rd degree damage, shaving is the recommended procedure.” – Dr. Toft

When you see 2^nd- and 3^rd-degree damaged cartilage through an arthroscope, it looks like angel hair waving gently under water.

Doc Probes, Digs, and Proclaims: “See, there’s damage there.”

SURGERY #3: 10 JAN 2006

RESULT: RUINED KNEE

Medial Meniscus thermal abrasion

Lateral release

Chondroplasty Shaving: Dr. claims this is Chondromalacia II/III.

 “Prof. Toft has made his name in two areas.  The other highlight in his work is abrasion arthroplasty, … a very useful tool for "regeneration" of severely arthritic knee joints in order to prevent knee replacement surgery.” - Wikipedia

 KNEE Problem Overview HERE

All Knee MRI’s HERE

Full Knee Operation Review HERE

Full Research on Chondroplasty Procedures HERE

.        

            Atrophied Left Leg

           BEFORE & AFTER

Jan 10, 2006, Anastasia undergoes Knee surgery in Munich.  A lateral release and a look at the Medial Meniscus is expected.  Instead, the doctor also shaves the Patellar cartilage and RF-heats the meniscus. Inflammation continues to this day, with concomitant pain and disability

KNEE SURGERY OVERVIEW

·         We made it very clear that the patient had spent 6 months bed-ridden, due to 2 consecutive spine surgeries

·         We made it clear (email) that the surgery was to regain walking strength to enable rehab post TDR surgery.

·         The pre-op MRI report states: “Fuer eine Chondromalazia patellae kein Anhalt” – Dr. Rothmeier

·         Chondroplasty was never discussed with us. No form of treatment on the patella was mentioned

·         The retro-patellar cartilage is now severely damaged, the left quadriceps are severely atrophied.

·         The post-op plan was ‘absurd’ – according to Dr. Toft’s own literature regarding post-op treatment for same.

28 NOV 2005, PRE-OP                6 FEB 2006 (1 MO POSTOP)                  1 MAR 2007 (14 M POSTOP)

IT IS APPARENT THAT THE RETRO-PATELLAR CARTILAGE IS VERY ROUGH. THIS EXPLAINS

WHY ANASTASIA CAN NOT PUT ANY PRESSURE ON THE KNEE-CAP WITHOUT SEVERE PAIN.

IT IS WELL KNOWN THAT CHONDROPLASTY SHAVING CREATES A ROUGH FIBROCARTILAGE.

CHONDROPLASTY GENERAL REJECTION in medical community

  Chondroplasty was never discussed with us.

#7 "most of the reports on abrasion arthroplasty are negative.” - Toft, M.D.

#8 “The unadulterated open abrasion of pathological articular cartilage has to be marked obsolete, today.” -Der Orthopäde

#9 "I have seen many patients who have had cartilage removed by surgeons for an average charge of $5000 and then they must have a knee replacement several years later." - Gabe Mirkin, M.D.

#9 “Surgery to trim cartilage in the knee is worthless”

#9  “arthroscopic lavage or debridement in patients with osteoarthritis of the knee is no greater than that of placebo surgery”

#9  “The people who did not have surgery on their cartilage did better than the people who had some of their cartilage removed”

#12 patients with traumatic chondromalacia had 60% good or excellent results compared to 41% good or excellent results in all others [4]

#13 “And to this day there is a very critical stance among the orthopaedic community towards abrasion arthroplasty.”- Toft, M.D.

#15 “The long-term value of this cartilage is dubious. Laboratory studies have shown that this repair tissue---histologically distinct from the normal hyaline articular cartilage---cannot endure for long.”

#19 “this procedure is not proven in terms of long-term improvement”

#20 “Many of the orthopedic community … argue that the new cartilage is of a quality inferior to that of the original hyaline” – Toft M.D.

#21  “satisfactory results were achieved in 25 per cent after forty shavings of the patellar cartilage”

POST-CHONDROPLASTY PT RECOMMENDATION: Our PT-Plans says: No Weight for 2 Weeks.

#2. The post-operative protocol included a 12-week non-weight bearing period, - Dr. Toft

#3 The key to success here is to keep the treated surface away from any excessive pressure or compression, which involves a total of two months on crutches. – Dr. Toft

#4 maintenance of a non-weight-bearing protocol for two months is essential. –Dr. Toft

#5 At any rate, you should reckon with a 8-week non-weight-bearing period after which time your articular cartilage defect will have healed over.

#7 the knee must be kept on a non-weight-bearing protocol for three months – Dr. Toft

#20 “Rehabilitation for shaving and abrasion patients requires up to three months of restricted activity,” – Dr. Toft

#20 “With some exceptions, this means not putting more than 30 pounds of weight on the operated leg for a period of three months following the operation.”

#20  “Surgeons who perform shaving and abrasion arthroplasty on a regular basis also understand the vital importance of a lengthy rehabilitation period”

GENERALLY ACCEPTED TREATMENT: Never discussed with us.  Surgery was ‘Urgent’.

#10  need for surgery in patellofemoral syndrome has been almost eliminated due to the improved understanding of its etiology and the introduction of the vastus medialis obliquus strengthening and taping program

#11  Strengthening of the quadriceps muscle when done properly often results in approximately 90% cure rate for this condition.

#14  An exercise program which strengthens the quadriceps muscles (extensors) and stretches the hamstrings

#17 Many cases of mild to moderate chondromalacia patella can be treated with just oral anti-inflammatory medication, weight loss and the proper type of therapeutic exercise.

Anastasia’s view … for 6 months. She can not go outside. We live on the 3^rd floor with no elevator.

We move to a new ground-floor apartment, with a Winter-Garden & Patio. This is really good news for Pushka! (And her slaves)

17 SEP 2006 – YOUR FAITH HAS HEALED YOU

17 September 2006. Though not Catholic, Nastia walks 2km to see the Pope. This is a small miracle in of itself.  She has not walked so far in 2 years.  She is nearly Pain Free … until she bends or lifts anything.

"I pray every day for a sign...Should I do a surgery or not? No signs...Noting. The God is silent"

 8 October 2006. Driving from Freising to Straubing.

Anastasia prays that if the car breaks down, it’s a sign.

One minute later, the car stops. (The engine is totally shot. The mechanics later can find no explanation for the burn-up.  The mileage was only a few thousand since I bought it.)

I call Anita to cancel and ask for a taxi. She sends their taxi, who takes us to Straubing.

OCT 2006 –SURGERY #4.    FOLLOWED BY 12 MONTHS BED-RIDDEN

In Straubing, the day before the surgery, MRI and Xrays are taken.  Dr. Bertagnoli is in Munich, at some very important meeting.  Thus, Dr. Bertagnoli is not able to have seen the new images.  Anastasia has not seen the doctor since May 2006, five months ago.  The images that he last saw are now one year old.  Anastasia insists that she wants to see or speak to the surgeon, to explain that her pain has subsided dramatically.  He calls her around noon, for about 3 minutes, and convinces her that ‘now is the perfect time’, and ‘the pain will just come back again later’.  She trusts him. She trusts that she is still a ‘Perfect Candidate’, and that her facets are fine, as well as her disc still having a prolapse. Both are wrong.

We ignored the SIGN.

TRYING OUT HER NEW BRACE.

NOT SHOWN: MASSIVE BRUISE ON BEHIND.

DESPITE THIS TRAUMA DIRECTLY TO THE SPINE, SURGERY WAS NOT POSTPONED.

ALL THE SOUP BOWL’S ARE SALTY-BROTH.  ANASTASIA CAN NOT HAVE SODIUM.  ALL OUR REQUEST FOR A LOW-SODIUM DIET WERE IGNORED. SHE HAS TO TAKE HER OWN EX-LAX, BECAUSE THE DOCTOR DOESN’T KNOW THAT AN ENEMA HAS 8000mG SODIUM.  

ANASTASIA PASSES OUT DUE TO DEHYDRATION FROM THE EX-LAX, HITS HER UPPER SPINE ON TOILET, AND TAIL. DOCTORS SHOW NO CONCERN FOR IT.

EXAMPLE IMAGE

SURGERY #4: IMPLANT OF PRODISC ADR,

9 Oct 2006. ADR by Dr. Bertagnoli, ProSpine.

THE INCISION IS BARELY STITCHED UP, AND SPLIT.

THE DOCTOR NEVER VISITS. WE WONT SEE HIM, OR HEAR FROM HIM, UNTIL 3 MONTHS LATER.

BEGIN 12 MONTHS HELL, BED-RIDDEN, UNABLE TO SLEEP PAIN.

AT LEAST BEFORE THE ADR, ANASTASIA COULD SLEEP.

DEC 13 2006.

IT CAN BE SEEN THAT THE DEVICE DOES NOT MOVE FROM EXTENSION TO FLEXION.

JAN 31^st 2007. VISIT TO STRAUBING TO MEET DR. B.

AFTER WAITING 7 HOURS FOR THE SURGEON, WE FINALLY GET TO SEE HIM AROUND 5:00PM.  BUT, HE BRINGS IN TWO SECRETARIES AS WITNESSES TO TAKE DICTATION!!!

ANASTASIA IS HORRIFIED and HUMILIATED. SHE’S BEING TREATED LIKE A LEGAL CASE!  SHE CAME BEGGING FOR HELP!

AFTER THE MEETING, FRAU HEINE ASKS TO BORROW OUR IMAGES TO MAKE COPIES.  OF COURSE, WE ARE NAÏVE AND HAND THEM OVER. IT WILL BE THE LAST WE EVER SEE THOSE IMAGES. MULTIPLE EMAILS, PHONE CALLS AND A PERSONAL VISIT LATER WE STILL CANT GET OUR IMAGES BACK. 

WHY!?

APRIL 14, 2007 – AFTER CONSULTATION WITH HIGH LEVEL NEUROSURGEON:

11/04 Lordosis, 8mm disc      10/06 Collapsed disc << 5mm 

LEVEL IS BONE-ON-BONE . This is a KNOWN cause of Facet Arthrosis.  As the disc collapses, the Facets take the load.

A COLLAPSED DISC IS A CONTRAINDICATION TO ADR BY SYNTHES’ DEVICE LABELLING.

Eisentein et. al.                                 SEP 2005 L4/5   

 OCT 2006  L3/L4: OK               L4/L5: FACETS FUSED  

PRE-SURGERY MRI: AXIAL PLANE

FACETS SHOW ARTHROSIS GRADE IV, HYPERTROPHY AN ABSOLUTE CONTRAINDICATION  TO TDR

“ANASTASIA LIKELY HAS NO MOVEMENT AT ALL BECAUSE OF HER PRE-SURGERY 'AUTO-FUSED L4/5 FACETS' AND THEREFORE I DO NOT EXPECT ANY MOVEMENT POST-ADR EITHER. THIS IS CONFIRMED BY PRE-SURGERY FLEXION/EXTENSION FILMS AND AXIAL MRI SHOWING NO MOVEMENT AT L4/5 SEGMENT AND END-STAGE (GRADE 4) FACET ARTHRITIS!!  … PLACING A MOBILE ADR INTO A NON-MOBILE OR STIFF L4/5 DOES NOT MAKE IT MOBILE.”  - (PRIVATE EMAIL FROM HIGH LEVEL ADR SURGEON)

MAR 2005.                                 AUG                                             DEC 2005 

Prolapse survives Jun and Sep 2005 surgeries, but is gone by Oct 2006.

OCT 2006: Prolapse Resolved.

concordant with Pts lower pain levels.

PRE-OPERATIVE IMAGES ABOVE

·        COLLAPSED DISC

·        GRADE III/IV FACET ARTHROSIS

·        PROLAPSE REABSORBED (LOW PAIN!)

CONTRAINDICATIONS TO TOTAL DISC REPLACEMENT:

1.    Synthes Spine: ”Radiographic confirmation of facet joint disease or degeneration.”

2.      FDA: ”Radiographic confirmation of facet joint disease or degeneration.”

3.      Spine-Health.com: ”clinically significant degenerative facet disease”

4.      Dr. Kulkarni: ”Facet arthropathy has been appreciated as a major contraindication”

5.      Rudolf Bertagnoli et.al.: ”Care should be used to assess patients for the presence of facet arthropathy,”

6.      Rudolf Bertagnoli et. al: ”Patients should be screened carefully for evidence of facet joint impingement/degeneration”

7.      Delamarter et. al: ”severe facet degeneration were excluded from the study”

8.      Zigler et. al.: ”The authors identify factors leading to clinical failure, including posterior facet arthritis”

9.      Tropiano et. al: ”Exclusion criteria included facet Arthrosis”

10.  David Thierry: ”emphasized the importance of normal facet architecture.”

11.  Matthew Scott-Young:  ”This is a failure of indication, in which the facet arthropathy is overlooked by the surgeon.”

12.  Le Huec, J.C.: ”This improvement is significantly correlated with facet arthrosis and muscle fatty degeneration.”

13.  M.E. Jansen: “pathology of the posterior elements. In such cases, fusion is still the first choice for treatment,”

14.  Balkan Cakir,: “The inclusion criteria …absence of facet joint arthrosis confirmed by CT, no pain relief after facet joint infiltration,”

Our opinion is that we would (despite of what you told me) still perform fluoroscopically guided spine infiltrations, especially since the MRI´s do show signs of facet degeneration (II° (-III°). – HIGH LEVEL ADR SURGEON FROM BAVARIA

 I think it´s possible a grade 4 arthrosis, I would never implant a pro disc in a such degenerated level.– ADR SURGEON, BAVARIA

INSTALLED DEVICE IS CLEARLY OVERSIZED.

HYPERLODOSIS  > 14.7 Deg. NORMAL < 3 DEG.

“In regards to the problem, the xrays do show 50 -75% distraction of the disc space over the level above and below.  It seems that this abnormally loads the facets - really sort of crushes them  sometimes -  or it can abnormally distract them and the nerves to the nerve roots causing leg pain too.”  – SPINE SURGEON FROM L.A.

“Indeed, the segment L 4/5 seems to be almost locked in hyperlordosis.”  – SPINE SURGEON, WEST GERMANY

Nine months Post-Op. Anastasia can not sit even a few minutes to eat dinner.  She spends all day in bed. Staring at the ceiling.

RESEARCH ON BIOMECHANICS OF THE PRODISC

Dr. Peloza states that the Prodisc will 'predictably' cause excessive loads to the facets.

Arvind G. Kulkarni et al.: disc incompetence (DDD) transfers the load to the facet joints which may lead to facet joint degeneration.

Dr. Thierry Marnay: placing a segment into too much lordosis may load the facet joints
Dr. Siepe's research indicates a 9.2% facet pain complex post ADR for L4/L5, and 28.1% for L5/S1.

DR. Moumene M, Geisler F.: ProDisc increases facet loading by 10%
DR. Shim CS et al.:  Degradation of the facets was seen in 36.4% of the CHARITE and 32% of the ProDisc.

S. M. EISENSTEIN, et al:  “Loss of height of an intervertebral disc can be expected to produce increased pressure on the facet joint surfaces posterior to it”

Dr. van Ooij A,: From 27 patients requiring revision there were: "eight patients with hypertrophic facet joint arthrosis … and three patients had developed hyperlordosis at the site of the prosthesis."

R.A. Kube et. a., CT/MRI saw 8/10 facet degeneration at the operative level. (SAS7)

Guilhem Denozière et al.: the model for an implanted movable artificial disc illustrated complications common to spinal arthroplasty and showed greater risk of instability and further degeneration than predicted for the fused model.

Dr. Bertagnoli: There was a trend that the facet force was decreased throughout flexion/extension for the Prodisc; [in cadavers]

(Who is right? Dr. Bertagnoli, or EVERYONE ELSE)

APRIL – SEPTEMBER 2007, SEARCH FOR AN ADR REVISON SPECIALIST.

AT 3 MONTHS: Dr. Fenk-Mayer’s email:

 “[Dr. B] after thorough review decided that a primary mechanical finding is not the leading pain generator - and thus further surgical intervention neither fruitful nor justified.”

BASICALLY, THEY DENIED THERE IS ANY PROBLEM, AND THUS IMPEDED HER TREATMENT.

“More than 90% of device-related complications are iatrogenic. Poor patient selection, improper implantation, and wrong sizing are the most common examples of surgical errors causing a higher risk of failure.”

“Due to the high vascular risk in anterior revision surgeries, these latter options should be performed only in specialized spine centers with a large experience in anterior approaches, using an experienced vascular surgical team.”

- R. Bertagnoli, Complications and Strategies for Revision Surgery in

Total Disc Replacement

APRIL 2006 – CENTER OF ROTATION PROBLEM DISCOVERY

  Neutral – Note Lordosis                 Attempted Flexion

Device height = 11mm vs 8mm above level.   Flexion @ L4/5 Locked. Fused facets torn by exaggerated arc and leverage effect of Prodisc core.

Red Arrows: Center of Weight shifts to the posterior, over the facets.

The level collapsed, crushing the facets. Then, putting an over-tall device into the space created a condition of hyperlordosis. 

With the fulcrum effect, flexing forward tears the facets apart.

Due to the hyperlordosis, the center of weight lies over the facets, putting a majority of the bodies load over them.

Anastasia could not bend forward or backward, or sit or stand. All she could do was lie in bed.

7 OCT 2007 RADIOGRAPHS:

EXTENSION                                                   FLEXION (severe pain)

Blue-Circle: Natural arc, Red: Prodisc Rotation arc

Center of Rotation (COR) of Prodisc (Red) doubles the facets arc.

Furthermore, the Prodisc translates A/P 1mm for every 3° of rotation.

Thus, for a total possible 20°, we see 6.6mm shear added to the already double arc.

MDK: Medizinischer Dienst der Krankenversicherung

(Medical Service of the Health Insurance)

Official Investigation Report by Dr. R Kargl, MDK

Bahnhofplatz 9, 84463 Mueldof, DE

06 February 2009

Regarding the Artificial Disc Replacement Surgery, by Dr. Rudolf Bertagnoli, 9 Oct 2006

“A Grave Error in Treatment”

     "In summary the appraiser must come to the conclusion that in the available case for completely incomprehensible, medically not understandable reasons,  it has been contravened grossly against the indication criteria for implantation of spinal disk protheses "

     Summary: Given the whole set of contraindications against this intervention, this measure has to be qualified as grave error in treatment.

BEGIN SEARCH FOR A SURGEON TO FIX DR. B's MESS

The following are the responses received from contacted surgeons regarding their experience in revision of a Prodisc, particularly at level L4/5, and their preferred or required method of revision (removal with anterior and posterior fusion, or posterior fusing leaving the device in-situ).   Notably, none admit experience with removal of a Prodisc at L4/5.   All, save Dr. Phong Dam Hieu, recommended fusing the device in-situ.

1. Dr. Jack Zigler, Plano Texas:  I would strongly recommend that you leave the ProDisc in place and do a posteriolateral fusion with good pedicle screw instrumentation.
2. Dr. Jeffrey Spivak (NY,NY):  I would personally favor leaving it in situ and doing a robust instrumented posterolateral and facet fusion with posterior decompression if needed. . Prodisc removal at L4-5 has significant added risk and is of little proven benefit.
3. Dr. Jonathan Steiber: My experience with ProDisc revision is limited ... I would favor some sort of posterior stabilization, likely with a posterior fusion in addition to an anterior interbody fusion.
4. Dr. Jean Paul Steib, Strasbourg FR:  I suggest to you an infiltration under CT scan of the both facets of L4-L5. If there is a good improvement, that means that the pain is coming from these joints. In that case a fusion without doing anything to the prosthesis would give a good result.
5. Dr. Charles Rosen, UCLA: As far as your surgery, I do NOT believe it is necessary nor wise to remove the prosthesis.
6. Dr. Reinhard von Bremen-Kühne (Hamburg, Germany): I dispose of only limited experience in TDR- Removal or Revision I would think of leaving the TDR in situ and adittionally fusing it from the dorsal via transpedicular instrumentation. This minimizes surgical riscs and showed satisfactory clinical outcome in the cases I have done.
7. Chefarzt Priv.-Doz. Dr. Oliver Diedrich: (Mannheim, DE), Ein Ausbau der Prothese ist sicherlich die letzte Behandlungsalternative. ... In unserem Patientenkollektiv wurde bisher noch keine Prodisc-L-Bandscheibenprothese in der Etage LWK 4/ 5 entfernt.
8. Dr. med. Roland Rißel (Albstadt, DE): In common it is quit difficult to remove a TDR from the level L4/5, also it is not impossible.Also it is not necessary to remove the artificial disc in all cases. Sometimes it will do to add an posterior fixation.
9. Dr. med. Stephan Noe (München, DE) I never removed a pro disc in level L4/5.  The easier and saver way is to fuse the level from behind and leave the pro disc in his place. There exist a removing tool for the pro disc. In level L4/5 i would prefer the anterior lateral aproach due to the risc of vascular complikations.
10. Dr. Phone Dam Hieu, (Brest, FR): I would recommend removing the lumbar prothesis then replacing it by a fusion with a cage + BMP. ... I think we have reasonable chances to reduce the hyperlodosis by decreasing the height and the anterior opening (or angle) of the L4-L5 space.

                     DENIAL OF MEDICAL CONSULTATION/TREATMENT BASED ON USA CITIZENSHIP

Here, we have asked Dr. Michael Mayer’s office for an appointment – for several reasons:

1. Dr. Mayer is an expert on Prodisc in Germany
2. Dr. Mayer has written an article questioning Dr. Bertagnoli’s 98.2% result claims (vs. 82.5%)
3. The Schoen-Kliniken apparently has an advanced MRI capability (Gd-DTPA-MRI)

 Herfs, Silvia Thursday, April 12, 2007 1:25 AM

Dear Mr. Scott, thank you for your e-mail. Mr. Scott, I regret to inform you that the Schoen-Kliniken-Group does not treat patient from the USA.
With best regards, Silvia Herfs

Brüggemann, Nils, (Director Schoen-Kliniken) Monday, April 16, 2007 8:31 AM

Dear Mr. Scott, Thank you very much for your e-mail and for your understanding that – as explained - we are not able to treat your wife in the Orthozentrum.

OCT 2007 –SURGERY #5.    WELCOME TO BEVERY HILLS, USA! – (on your back)

Dr. Regan to Anastasia: “BMP has been 100% successful. We plan to restore normal height and lordosis.  Sometimes because of the increased distraction with the artificial disc the number may be 10-11.

Waiting outside surgeon’s building – of course there was a fire-alarm test. Once per year.

SURGERY #5: PRODISC EXPLANTATION AND REVISION TO A FUSION

1. Dr. van Ooij's report on 27 revisions with posterior instrumentation,  had only 1 out of 27 with an acceptable outcome.  The other 26 had continuing leg/back pain.

“The other solution, a posterior fusion without removing the disc prosthesis, was performed eight times in our group. The results were disappointing in most patients up till now. The reason for this finding is unclear. One of the reasons could be a constant pain source of the remaining disc prosthesis, as is possible after a posterior or posterolateral solid fusion without removal of the painful disc at the same level.”

Yellow arrows point to great vessels

Anterior extraction was probably precluded by the scaring over the common iliac and vena cava at the L4/5 level.

The optimal extraction would have been anteriorly, taking the device out the same groove it went in on. Unfortunately, at this level, the vascularity blocks this path, as seen to the left. The only way to get the device out is laterally, through the Psoas muscle.  This will also require a significant osteotomy (removal of bone) from the vertebra to clear space for the 6.5mm tall keels. 

The surgery results in aggravation of the genitofemoral nerve:

Transpsoas access to vertebra

                   Transpsoas access to vertebra

The ‘Genitofemoral’ nerve transits the Psoas, which had to be sectioned (split vertically) to make space to extract the Prodisc through.  This nerve wires up the groin area and thighs.  Irritation causes parathesia, weakness and spasms.

 http://www.medscape.com/viewarticle/487929_4

Six patients in this series developed groin/thigh discomfort after surgery. These symptoms are consistent with the cutaneous innervation of the genitofemoral nerve. This presumable 30% incidence of genitofemoral nerve palsy is of some concern. However, these symptoms resolved within 4 weeks in 4 of the 6 patients who developed them after surgery. Both patients experiencing longer-lasting symptoms underwent a 3-level procedure. Two other patients underwent multilevel fusions without similar complaints. At this point, it is unclear to us whether or not this technique is appropriate for multilevel cases. It is difficult to draw firm conclusions regarding the incidence of complications given the relatively small number of patients. In most of the cases performed, the genitofemoral nerve was identified but necessitated retraction to access the disc space.

The lateral retroperitoneal approach obviates the need to dissect and mobilize the common iliac vein and artery, as is necessary with transperitoneal exposure. Dissection of the sympathetic plexus is also excluded through this approach.

The genitofemoral nerve arises from the L1 and L2 roots. It passes obliquely through the substance of the psoas and emerges from its inner border at a level corresponding to the L3-L4 interspace. It then descends on the surface of the psoas muscle, normally under the cover of the peritoneum, and divides into the genital and femoral branches. The genital branch passes outward on the psoas major and pierces the fascia transversalis or passes through the internal abdominal ring. It then descends along the back par of the spermatic cord to the scrotum, and supplies, in the male, the cremaster muscle. In the female, it accompanies and ends in the round ligament. The femoral branch of the genitofemoral nerve descends on the external iliac artery, sending a few branches to it and, after passing beneath the Poupart ligament to the thigh, supplies the skin of the anterior aspect of the thigh down about midway between the pelvis and knee.

The authors recommend staying in the anterior one-third of the psoas muscle to avoid nerve root injury. Visualization and protection of the genitofemoral nerve should avoid permanent paresthesias in the anterior thigh. Intraoperative neurologic surveillance may also provide added benefit in avoiding the exiting nerve roots, especially at L4-L5, where the L3 nerve root can cross the disc space and may be at risk if the approach is in the anterior one-half of the psoas muscle. The electromyograph (EMG)-based Neurovision (Nuvasive, San Diego, CA) is designed to provide real time detection of proximity to the nerve root.

LOS ANGELES IS A BLUR OF LIGHTS AND PAIN

 LA. BEVERLY HILLS. CHRISTMAS 2007. NEW YEAR 2008.

ANASTASIA IS IN BED, WITH A MASSIVE TRAUMA AFTER THE REVISION SURGERY

AFTER THE SURGERY:  ANASTASIA MUST USE A WALKER FOR SEVERAL MONTHS

Anastasia was terminated by Texas Instruments while on disability,

1999: WELCOME BACK TO AMERICA!

NOTE THE MASSIVE CORPECTOMY OF THE L5 VERTEBRA!

After this surgery, Dr. Regan publishes an article:..."The large central keel effectively precludes a lateral approach in the case of revision surgery..."

 Revision Strategies Involving Lumbar Artificial Disc Replacement

Pablo R. Pazmiño, MD  and John J. Regan, M.D.

Seminars in Spine Surgery, Vol 20, No. 1, March 2008

 Pg. 44: Advantage of CHARITE’ Artificial Disc

It is important to note one definite advantage of the CHARITE’ Artificial Disc compared with others that posses a large central keel, such as the ProDisc (Synthes) or Maverick (Medtronic Sofamar Danek).  The large central keel effectively precludes a lateral approach in the case of revision surgery because a corpectomy would need to be performed to free the prothesis from the adjacent vertebral bodies.”

Fig. 4   25 NOV 2005                          Fig. 5:     1 APL 2007  XRAY               Fig 6:      14 OCT 2007 XRAY

The natural disc height and lordosis is seen Fig 4., and in Fig 5. in the level above the L4/5 Fusion (measure to be 7mm).The Fusion space is 14mm. 

The normal L4/5 lordosis angle is about 3 degrees.  The Fusion is about 15 degrees.

NOTE THE EXTREME SPACE BETWEEN VERTEBRAE WITH THE FUSION

Dr. Regan stated that the reason to remove the Prodisc, was, in his words:

“BMP has been 100% successful. We plan to restore normal height and lordosis."

COMPARISON OF L4/5 INTERSOMATIC HEIGHT AND LORDOSIS: PRODISC VS. FUSION

Fig. 1.   Measurements of disc space heights                    Fig. 2.  Lateral Xray image, 14 Oct 2007

NOTE THAT THE L3/L4 HEIGHT IS 0.71um, WHILE L4/L5 IS 1.40um

THE FUSION HEIGHT IS EXACTLY 2X NORMAL!

PROOF OF EQUIVALENCE OF DISC SPACE HEIGHT AND LORDOSIS, PRE AND POST REVISION

Fig. 7:    PRE- REVISION                                           Fig. 8.          POST-REVISION

NOTE THAT THE RED AND GREEN DOTS OUTLINE THE L4/5 L5/S1 VERTEBRAE.

THIS IS A MERGE OF THE TWO ABOVE IMAGES. 

GIVEN THAT THE RED & GREEN DOTS ALIGN NEARLY EXACTLY HERE, SUCH THAT THE VERTEBRAE ARE AS WELL MATCHED,    IT IS CLEAR THAT THE PRODISC SEGMENT AND FUSION SEGMENT HAVE THE SAME HEIGHT AND LORDOSIS.

     Fig. 9:  Graphical Overlay of Fig 7 and Fig 8

The final image reflects the result that would have been obtained had the Prodisc been left intact.  Given that the Disc Space Height and Lordosis are exactly the same, there is very little advantage to having removed the device.   The disadvantages include a massively traumatic approach through the Psoas, resulting parathesia of the left thigh, a sypathectomy (sympathetic plexus) onset Complex Regional Pain Syndrome (in remission, from Hyperbaric Oxygen Treatment), and an expense of over $130,000 (the patient could have had the device fused in-situ with full coverage by her insurance in Germany).  Furthermore, rather than a solid, well seated Prodisc between the vertebrae, there is now apparently nothing.  The extreme distance between the vertebrae resulted in Psuedarthrosis … regardless of the 100% fusion successes with BMP reported by Dr. Regan.

INVESTIGATION OF CAUSES OF FUSION SUCCESS AND FAILURE

According to Gerard K. Jeong et. al.:

 “Several factors dictate the successful incorporation of grafted bone and include (1) the type of bone graft, (2) the host site, (3), the vascularity of the graft and host-graft interface,(4) the immunocompatibility between the donor and the host, (5) preservation techniques, and (6) local (cytokines, growth factors, etc) and systemic factors (smoking, steroids, etc). In the posterolateral spine, autogenous bone fusion matures through a series of steps including inflammation, fibrocartilage formation, enchondral ossification, and final remodeling.

Osteogenesis is the synthesis of new bone by cells derived from either the graft or host and refers to the ability of graft or host cells to directly form bone. Only autogenous bone marrow elements possess osteogenic properties with osteoinductive proteins, osteoprogenitor cells, and a local blood supply. Osteoinduction is the process by which mesenchymal stem cells at and around the host site are recruited as osteoprogentior cells to differentiate into mature osteoblasts. Recruitment and differentiation are the two characteristic processes of osteoinduction and are tightly modulated by various graft matrix–derived growth factors and cytokines. These growth factors include BMP, platelet-derived growth factors (PDGFs), fibroblast growth factors (FGFs), insulin-like growth factors (IGFs), vascular endothelial-derived growth factors (VEGFs), and various interleukins (ILs). Osteoconduction refers to the process by which an organized, microarchitectural framework is established that acts as a scaffold to support the formation of new host bone. Most commercially available bone graft extenders (DBM, allograft, calcium salts, coral, hydoxyapatites, etc) serve as osteoconductive agents with limited to no osteoinductive potential.”  , HSS J. Sep 2005, 1(1): 110-117

 It is clear that inter-body disc space height is highly correlated to osteogenesis, given the communicative properties of inflammation, growth factors and cytokines to stimulate osteoinduction.  As with any communication, the signal decays as the square of the distance, and the development of a microarchitectural framework is proportionally unlikely.

The following compares a successful arthrodesis (right image) of a 50 year-old male, with that of a psuedarthrosis of a 32 year-old female.   Both employed osteogenic rhBMP-2 and allograft.

                     PSUEDARTHROSIS                                                SUCESSFUL ARTHRODESIS / OSTEOGENESIS

32 Y/O Female,  L4/5 PEEK+rhBMP-2, @ 24 months               50 Y/O Male, L4/L5  (online Fig. 4)

NOTE THE GROSS DIFFERENCE IN INTERVEREBRAL DISC SPACE HEIGHT!