Long Term Studies – Charite’

[Harrison]

At the recent NASS annual meeting, a group of doctors presented a study to determine the long-term “clinical and radiographic results and incidence of complications” in a large number of lumbar arthroplasty patients. The following is excerpted from The Spine Journal.

Patient Sample

§ 226 patients who underwent lumbar arthroplasty with the Charite device (earlier designs than implanted today, described as third generation)
§ Had surgery anywhere from 1989 to 1995.

Methods

§ Multi-center study, three spine units in France
§ 130 females, 96 males
§ 154 one levels, 72 two-levels, 1 three-levels
§ Age range: 22-58, mean age 37
§ Total of 301 devices across 226 patients, from L4-S1
§ Minimum of 10 year follow-up, from 10-16 years

Results

§ 87.4% remained mobile or 263 prostheses on dynamic X-rays
§ Clinical outcomes were excellent or good; 78.8% or 178 patients
§ 93.3% of working patients returned to work after surgery; or 196 returned to work and were still working at follow-up
§ 80% working at the same activity level as before surgery
§ 77% hard laborers 63.6% returned to hard labor and continued at this level at or beyond the 10 follow-up
§ Adjacent-level disease requiring re-operation was 2.7% or 6 patients
§ 2.2% cases of subsidence or patients, 3 requiring surgical intervention

Conclusion

§ “…clinical outcomes, rate of return to work, and functional results were all better than results reported in literature reported for lumbar procedures.”
§ “the incidence of adjacent-level problems are much less than rates reported for fusion.”
§ “complications were primarily due to poor prosthesis positioning, and the learning curve of the procedure. Proper indications play a pivotal role in clinical success.”
___________________________________________

These findings are both validating and helpful. Though these arthroplasty devices are from an earlier generation, the results are better than some have “argued” here on the forum. Stated differently, they correlate positively with patient outcomes as seen here in the past 24 months.

With improvements of the Charite’ design, and especially surgeons’ training, I hope to see this positive trend continue and improve. However, this does not absolve any of us from understanding our multifaceted role as patients. We must understand the qualifications – and disqualifications – associated with an artificial disc replacement. See here for qualification/disqualification criteria.

[Harrison]

Just a quick note to mention the obvious -- this summary is quite significant for several different reasons. I'll sit back for a bit and look forward to any comments.

[kappa5070]

Why does multiple level DDD exclude someone? What if you have moderate, currently painless adjacent level DDD, and 1 level(L5-S1) rather severe and painfull DDD. Why cant I get ADR on just that level? A fusion surgeon agreed to do a fusion at one level. Are these contraindications absolute, or can a surgeon use their discretion? The reason I ask is Im going to a consult with Dr. Saeed Bajwa on Dec 4 and I need to be armed with as much information on this subject as possible. Im afraid I will be forced into a fusion. This is a life changing descision and I really think Im a great candidate for ADR. Im young, muscular, low body fat, no facet problems, no instability, no bone density issues. I just have some adjacent level DDD. I also have VA medical insurance on top of my blue cross HMO. I see they are covering ADR for vets(its on the charite website). They will send you to Walter Reed or a nationally recognized spine center of your choice. I wonder if they would cover multilevels or Germany? Harrison, sorry if I got off topic. I just wanted to post here so you would read this. I love this website and when I become a Chiropractor and finish being a broke student, I will financially support the website. Thanks for any input.

[livjoyful]

I have DDD and had a Charitte on L5/S1 in May. L4 is a moderate pain generater. My surgeon told me originally i would only get about a year out of my L4. After surgery he said about 5 years before it also needs replacing. It was because of my DDD that 6 other Orthepedic surgeons said I was NOT a candidate for fusion as it would just put to much stress on my other discs and speed up the DDD. Dr. Gurr fixed a herniated L4 during my surgery. At the time of my discogram, (about 4 months pre-op) L4 was a very mild pain generater.
I dont know if this has helped or hindered you as it seems to go against what your Dr. has told you.

[kappa5070]

My fusion Dr. thinks my L5-S1 is the main pain generator and the other discs are beginning to degenerate, but are all right for now. Im just concerned that the ADR surgeon I go see in Dec. will turn me down after reading the strict criteria on the Charite website. Dr. Bitan turned me down for the Kineflex study because he felt my DDD was too pronounced at L3-L4. Im just fusterated, I want an ADR and hope this surgeon will agree to do it on me.

[Harrison]

Kappa, thx for your kind words, but pls stay on topic. As well, you may get more help/responses in a topic specific to your area of inquiry.

If you or anyone else want the original study I abstracted, just email or call me (do not post here).

Thanks.

[kappa5070]

Sorry about that. Ill get the hang of this eventually.

[Blair]

woohoo! guess I'm in the 2.2% sweet! hahaha
sorry, I have to laugh at this it's my way of getting through it.

[deppmann]

Thanks for posting this Harrison! At 1-1/2 years post-op it's great to hear the long term sucess rates are that good. It really gives me hope that I will continue to improve and that my relief will last!
Thanks again and Merry Christmas