Hybrid Help

[bogiewan]

Well I have been reading the posts in this community for a while and thought I should jump in. I have been dealing with lumbar pain for nineteen years this December, so there is a lot of history that I cannot possibly share here. It all started with a bending and twisting injury that was diagnosed as pulled muscles. I met with many docs for ten years and ended up with a diagnosis of Ankylosing Spondylitis. I was treated for this for seven years, which included numerous drugs and PT sessions. I was encouraged to visit the Cleveland Clinic because things just didn’t seem correct for AS. Cleveland verified that I did not have AS but did have significant damage to L4-L5. MRIs later showed DDD at L4-L5, herniations at L5-S1, C6-C7, T2-T3, & T3-T4, with numerous Schmorls nodes in Thoracic. Met Nuerosurgeon and did fusion of C6-C7 in October of 2010. Finally had enough of lumbar region and went back to Nuero for consult. He told me that I was ADR candidate for lumbar and to get an opinion from someone who is doing a lot of these. I Found Dr. Don Kovalsky in Mount Vernon Ill. He was a principal investigator during the Prodisc clinical trials. He wants to do a hybrid surgery of fusion at L4-L5 and Prodisc at L5-S1. He wants to do fusion because I only have 1mm of disc left and some arthritis in facet joints at L4-L5, but wants to put Prodisc at L5-S1. He said I have some miss alignment at L5-S1 and he may not be able to put Prodisc in, but would not know for sure until he was in there and could see if he could correct the alignment. My wife and I seem very impressed with this Doc and are ready to do something. Of course BCBS Anthem denied, and we are in the appeal process. As I have been reading the posts, I find that I may have to get Laurie Todd’s book for this process. I do have some questions for the community.
1. It seems like a lot of people are going out of country, am I missing something?
2. Has there been any experience with Dr. Don Kovalsky in Mount Vernon Ill?
3. Has anyone had this hybrid surgery in the lumbar?

[annapurna]

1) Most, if not all, of the people who've gone overseas did so because they couldn't get the treatment in the US or couldn't afford it in the US. As you can obviously get treatment from this surgeon, the first doesn't apply. As BCBS didn't approve your plan, the second might.

2) No experience on our part

3) It's a little unusual to see an ADR at L5S1 and fusion at L45. Most of the lumbar hybrids you see on this board are the reverse. You should ask if this surgeon has done this before or has experience with hybrids in general. My wholly untrained instinct says that you've got the potential to overload the L5S1 facets with a hybrid like this. On the other hand, I can definitely see a concern with two adjacent fusions and potential future problems with your SI joint and hips.

[Slackwater]

Originally Posted by bogiewan

DEL.TEXT
... Dr. Don Kovalsky in Mount Vernon Ill. He was a principal investigator during the Prodisc clinical trials. He wants to do a hybrid surgery of fusion at L4-L5 and Prodisc at L5-S1.
DEL.TEXT

1. It seems like a lot of people are going out of country, am I missing something?
2. Has there been any experience with Dr. Don Kovalsky in Mount Vernon Ill?
3. Has anyone had this hybrid surgery in the lumbar?

Ans.1: Some people go out of country due to insurance coverage positions, paying out of pocket, surgeon preference, device preference, etc.

Ans.2: No. I am in California.

Ans3: No surgery yet on this side, although scheduled with an orthopaedic surgeon again.

You wrote Dr. Kovalsky was a ProDisc investigator. I trust his opinon more than my own on the correct path for you.

There may be a challenge to line up the mean center of rotation of a multi-level ADR strategy.


The PDF attachment is:


EuroSpine 2008
SP 3
Hybrid construct: fusion L5S1 and disc arthroplasty L4L5 for DDD.
3 years follow up
• JC Le Huec MD PhD, S Aunoble MD, R Meyrat MD, C Tournier MD,


~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

2009 North American Spine Society, Annual Meeting, Poster #158

158. The Hybrid ADR: Long-Term Analysis of Sagittal Motion and Clinical Outcome after Concurrent ADR + ALIF (Minimum 2-Year Follow-Up)

Alexandre Rasouli, MD 1, Rick B Delamarter, MD 2, L.E.A. Kanim, MA2, Nomaan Ashraf, MD 2, Brandon Strenge, Sr., MD 2;

1 University of California, Irvine, Newport Coast, CA, USA;

2 The Spine Institute at Santa Monica, Santa Monica, CA, USA


BACKGROUND CONTEXT:
A recent FDA-sponsored randomized controlled study of the Prodisc-L (Synthes Spine, Westchester, PA) lumbar disc replacement established superior clinical outcomes with preservation of motion at both surgical and adjacent levels, as compared to lumbar fusion.

Patients frequently present with pathology at the L4-L5 and L5-S1 levels and are not candidates for arthroplasty at the L5-S1 segment.

PURPOSE:
This study sought to evaluate clinical outcomes and the sagittal range of motion of single-level ProDisc-L ADR adjacent to a concurrent ALIF (InFix stand-alone cage, Abbott Spine, Austin, TX).

STUDY DESIGN/SETTING:

Prospective Cohort.

PATIENT SAMPLE:

Twenty-three patients underwent simultaneous lumbar
ADR at L4-L5 and ALIF at L5-S1.

OUTCOME MEASURES:
Radiographic evidence of motion in the sagittal plane pre-and post-operatively at the operated and adjacent levels were measured.

Oswestry Disability Index (ODI), Visual Analog Score Pain (VAS-P), and Visual Analog Score Satisfaction (VAS-S) data were also collected.

METHODS:
Patients were evaluated pre-operatively, at six weeks, three months, six months, and annually for 2-5 years postoperatively with lateral flexion-extension dynamic films and with completion of Oswestry and VAS surveys.

RESULTS:
At the motion segment adjacent to the ADRþALIF constructs (L3-L4), the mean preoperative range of motion was 8.49(SD 2.83), compared to 8.67postoperatively (SD 2.55, pO0.50). The mean preoperative range of motion at levels undergoing ADR (L4-L5) was 10.15(SD 2.71) versus 12.28postoperatively (SD 2.63, p50.011). The mean preoperative range of motion at the L5-S1 segment to undergo fusion was 1.90(SD 2.44), with all patients’ having a postoperative range of motion of 0.00 (pO0.05). At 2-5 years postoperatively, all patients had significant reductions in both ODI and VAS scores relative to preoperative levels (p!0.05). There
were no revision surgeries or reoperations at adjacent levels.

CONCLUSIONS:

The use of the hybrid ADR - ALIF construct does not

inhibit the efficacy of fusion at the ALIF level nor does it inhibit preservation of ROM at the ADR level. Most significantly, the nonoperative level adjacent to the hybrid construct maintains its preoperative ROM at 2-5 years postoperatively. There were no revision surgeries or reoperations at adjacent levels. Clinically, patients demonstrate significant improvement in pain and reduction in disability.

FDA DEVICE/DRUG STATUS:

ProDisc-L: Investigational/Not approved; IN-FIX: Investigational/Not approved.
doi: 10.1016/j.spinee.2009.08.194

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
ProDisc two-level FDA IDE results are positive as reported on ADRsupport.org/forums/LINK . The results below in JBJS are two ADR/TDR devices, not Hybrid.

Pubmed ID: 21398574
The Journal of Bone & Joint Surgery, Volume 93, Issue 8
J Bone Joint Surg Am. 2011; 93:e41 1-2 doi:10.2106/JBJS.J.01847
© 2011 The Journal of Bone and Joint Surgery, Inc
Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the

ProDisc-L Total Disc Replacement Compared with
Circumferential Arthrodesis for the

Treatment of Two-Level Lumbar Degenerative Disc Disease: Results at Twenty-four Months

Rick Delamarter, MD1; Jack E. Zigler, MD2; Richard A. Balderston, MD3; Frank P. Cammisa, MD4; Jeffrey A. Goldstein, MD5; Jeffrey M. Spivak, MD5

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

ProDisc is semi-constrained in design. Charite' is unconstrained. One reference on unconstrained two-level ADR with Charite' is from Drs. Schmidt, Zander, Rohlman, Galbusera and H.J. Wilke/Germany, pubmed 20361341 pointing more towards a hybrid.


I recall other journal articles from Drs. Zander, Rohlmann and Wilke wrote in (Journal of Biomechanics, Clinical Biomechanics, ...).

[Jstuckey]

I am a new lumbar hybrid... 4 weeks post op - so far so good. Would be happy to talk with you. I had facet damage at L5-S1 too severe for an ADR at that level. On the other end of the spectrum, I have mild DDD at several levels above my operative site too severe for a standard fusion (in my opinion). I feared I would have deteriorated right up my spine with a fusion - which is all my insurance would pay for. So.... overseas I went for a hybrid out of pocket. It cost what a new car would, and a much better investment in my opinion!

[Jstuckey]

One other thing: Why would they put an ADR at L5-S1 with a fusion above? I was told that lowest level has very little natural movement anyway. A fusion above seems very counter-intuitive. My L4-5 was bone on bone and Mr Boeree did fine with installing an ADR there anyway. I had mild facet damage there also - what is your level of involvement of facet damage? Mild damage seems to be OK, but anything over that is asking for trouble. If you are in a situation where your facets are pretty well shot, you might be better off with a full fusion. (Just things to research and question your doctors about)

[bogiewan]

Annapurna,
Thanks for the reply. My surgeon stated that he has done multiple hybrids, although I don't remember if he said this particular combination. I see on this forum that the combination is usually reversed. I am concerned about the L5S1 issues you mentioned and this is making apprehensive.
Thanks,
bogiewan

[bogiewan]

Slackwater,
Thank you so much for taking the time to respond with such valuable information!!!!!!

[bogiewan]

Originally Posted by Jstuckey

One other thing: Why would they put an ADR at L5-S1 with a fusion above? I was told that lowest level has very little natural movement anyway. A fusion above seems very counter-intuitive. My L4-5 was bone on bone and Mr Boeree did fine with installing an ADR there anyway. I had mild facet damage there also - what is your level of involvement of facet damage? Mild damage seems to be OK, but anything over that is asking for trouble. If you are in a situation where your facets are pretty well shot, you might be better off with a full fusion. (Just things to research and question your doctors about)

Well, you certainly have great questions. I was told that a portion of my pain was coming from arthritis in my facet joints at L4L5 and if he put an ADR in there , I would continue to have pain in that area. The Dr said I would not be very happy with him if I went through this and still had the pain. He stated that by locking the facets down via a fusion, the pain would subside. I do have some misalignment at L5S1 and he could not guarantee an ADR. I may wake up with a double fusion. I haven't seen another hybrid on this site like my proposed procedure.
Thanks for taking the time to reply and I hope recovery goes very well,
bogiewan

[bogiewan]

I thought of another question. Does anyone know of a resource where a person can find the symptoms of a particular defect? Example: Posterior disk bulge to the right at L4L5, what should a person experience with this? Does it affect the bladder, siactica, knee, what else. I have been looking and cannot find anything. I can go to a chiropractor and explain what is bothering me and he knows what is generating the pain. Is there somewhere I can gain that knowledge shy of med school?

[Slackwater]

Originally Posted by bogiewan

I thought of another question. Does anyone know of a resource where a person can find the symptoms of a particular defect?
DEL.TEXT
Is there somewhere I can gain that knowledge shy of med school?

Nerves map into the body in somewhat specific regions called dermatomes. The good news is there is a correlation between humans we can use. The challenge is nerve mapping also works slightly outside the area dermatome shown on the maps and it is sometimes described as lightly innervated. There are predictive tests that can be done in a General Practioner's (GP) office. So yes, dermatomes.

Bing dermatome (link to many possible explanations)
Starting Example: dermatome.LINK

The below looks realistic and the author is real:
Causes of Sciatica Pain and Sciatica Symptoms with Info On Sciatic Nerve Involvement



~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Another viewpoint:
My GP said Piriformis X times over X visits. The PT professionals and orthopaedic fellows said disc herniation. There may not always be agreement.