AETNA: Charité studies, data, and conclusions

[tmont]

From Jan 2006. Came across this while surfing for other things. Results and details of several studies, some about as 'long term' as can be had at this date. First study mentioned talks primarily about complications. Includes European study data--there's also a paragraph on ProDisc implantations 7-11 years later. Excerpt:


"Background

Since the 1970s, investigators have been working on developing an artificial prosthetic intervertebral disc (IVD) that can be used to replace degenerated intervertebral discs (Diwan, 3t al., 1997). Most of the published clinical evidence for artificial prosthetic intervertebral discs has been of those that replace the entire disc.

The major potential advantage of a prosthetic intervertebral disc over current therapies for degenerated disks (such as spinal fusion or diskectomy) is that the prosthetic intervertebral disk is intended to restore or preserve the natural biomechanics of the intervertebral segment and to reduce further degeneration of adjacent levels

van Ooij et al (2003) reported a series of 27 patients who presented with unsatisfactory results or complications after Charite disc replacement. Most patients were operated on at the L4 - L5 and/or the L5 - S1 vertebral levels. The patients were evaluated with plain radiography, some with flexion-extension x-rays, and most of them with computed tomography scans. The group consisted of 15 women and 12 men. Their mean age was 40 years (range, 30 - 67 years) at the time of operation. The patients presented to the investigators a mean of 53 months (range 11 - 127 months) following disc replacement surgery. In two patients, an early removal of a prosthesis was required and in two patients a late removal. In 11 patients, a second spinal reconstructive salvage procedure was performed. Mean follow-up for 26 patients with mid- and long-term evaluation was 91 months (range 15 - 157 months). Early complications were the following: In one patient, an anterior luxation of the prosthesis after 1 week necessitated removal and cage insertion, which failed to unite. In another patient with prostheses at L4 - L5 and L5 - S1, the prosthesis at L5 - S1 dislocated anteriorly after 3 months and was removed after 12 months. Abdominal wall hematoma occurred in four cases. Retrograde ejaculation with loss of libido was seen in one case and erection weakness in another case. A temporary benefit was experienced by 12 patients, while 14 patients reported no benefit at all. Main causes of persistent complaints were degeneration at another level in 14, subsidence of the prosthesis in 16, and facet joint arthrosis in 11. A combination of pathologies was often present. Slow anterior migration was present in two cases, with compression on the iliac vessels in one case. Polyethylene wear was obvious in one patient 12 years after operation. In eight cases, posterior fusion with pedicle screws was required. In two cases, the prosthesis was removed and the segment was circumferentially fused. These procedures resulted in suboptimal long-term results. In this relatively small group of patients operated on with a Charite disc prosthesis, most problems arose from degeneration of other lumbar discs, facet joint arthrosis at the same or other levels, and subsidence of the prosthesis"


full article here:

http://www.aetna.com/cpb/data/CPBA0591.html

[Alastair]

Well first of all, van Ooij is a great anti ADR guy so he is looking for anything NOT right.

Its an interesting study and thanks for posting that Trace.
A Dutch lady who was with me at the AK was having problems after her revision 2 level and ended up with Van Ooij removing the ADR and doing a double fusion- - - she is worse rather than better now.
Best
Alastair

[Mariaa]

Thanks Trace,
Interesting ... covers all the areas that I'm hoping to avoid having problems with if and when I have this surgery done (and before I become an all fusion level case)~

[tmont]

Sir A,

It starts off negative but gets better; that was pretty much the only 'all neg' study and I found it really interesting to see so many grouped together and AETNA's conclusions. I also want to hear the guys who are against ADR, and why!

It was also nice to have some of the
European background and results for a change...and I didn't think ProDisc had 11 years in already, so that was another discovery.

I'd love more info on the bold-faced statement though:

" These investigators concluded that the Prodisc lumbar total disc replacement appears to be effective and safe for the treatment of symptomatic degenerative disc disease. Gender and multi-level surgery did not affect the outcomes, whereas prior lumbar surgery or an age of less than 45 years was associated with slightly worse outcomes. The authors further stated that longer follow-up of this cohort of patients and randomized trials comparing disc replacement with arthrodesis are needed."


(also, if someone would only do an 'all cervie' study too...?? )

Trace