Publication: Clinical Results of TDR (Lumbar) With ProDisc II: 3 Year Results

[Justin]

Spine, Volume 31(17), 1 August 2006, pp 1923-1932

Clinical Results of Total Lumbar Disc Replacement With ProDisc II: Three-Year Results for Different Indications

[Clinical Case Series]
Siepe, Christoph J. MD; Mayer, H Michael MD, PhD; Wiechert, Karsten MD; Korge, Andreas MD

From the Spine Center, OrthoCenter Munich, Munich, Germany.
Acknowledgment date: July 25, 2005. First revision date: September 11, 2005. Second revision date: October 13, 2005. Acceptance date: October 19, 2005.
The manuscript submitted does not contain information about medical device(s)/drug(s).
No funds were received in support of this work. One or more of the author(s) has/have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies.
Address correspondence and reprint requests to Christoph J. Siepe, MD, Spine Center, OrthoCenter Munich, Harlachinger Str. 51, D-81547 Munich, Germany; E-mail: CSiepe@Schoen-Kliniken.de

Study Design. Prospective study analyzing midterm clinical results of total lumbar disc replacement (ProDisc II) for different indications.

Objectives. To assess functional outcome after total lumbar disc replacement (TDR) treated for varying indications.

Summary of Background Data. Despite its frequent use and increasing popularity, indications and contraindications for TDR have not been defined precisely at this stage and remain a matter of debate, leading to disc replacement procedures in a variety of pathologies that have not yet been evaluated and compared separately.

Methods. Patients meeting inclusion criteria were evaluated prospectively according to Visual Analogue Scale (VAS), Oswestry Questionnaire, SF-36, and numerous clinical parameters. Indications included degenerative disc disease (DDD), DDD with accompanying soft disc herniation (nucleus pulposus prolapse, NPP), osteochondrosis following previous discectomy, and DDD with presence of Modic changes. Postoperative improvement was recorded and analyzed for influence of preoperative diagnosis.

Results. Overall, 92 patients from four groups with a mean follow-up of 34.2 months (minimum, 24 months) achieved significant and maintained improvement from preoperative levels (P < 0001). Patients with DDD + NPP achieved results significantly better than patients from the other groups (P < 0.05). Presence of Modic changes or previous discectomy did not influence outcome negatively. Improvement was achieved for both monosegmental and bisegmental disc replacements (P < 0.05), nevertheless with significantly inferior results for bisegmental interventions at 12- and 24-month follow-up and considerably higher complication rate. While older patients were still highly satisfied with postoperative outcome, better functional outcome was observed in younger patients.

Conclusion. Present data suggest beneficial clinical results of TDR for treatment of DDD in a highly selected group of patients. Better functional outcome was obtained in younger patients under 40 years of age and patients with degenerative disc disease in association with disc herniation. Multilevel disc replacement had significantly higher complication rate and inferior outcome. Results are significantly dependent on preoperative diagnosis and patient selection, number of replaced segments, and age of the patient at the time of operation. Because of significantly varying outcomes, indications for disc replacement must be defined precisely.

© 2006 Lippincott Williams & Wilkins, Inc.

[Harrison]

Wow, interesting conclusion -- given how well multilevel Prodisc patients have fared. My understanding is that satisfaction rates among Prodisc patients is quite good.

[ADR in the USA]

As someone needing multi-level ADR, I am bias; I always like to hear positive results and don't like the fear that hearing about negative results brings up. However, I try to look at this objectively. All FDA clinical trials are very selective about participation. Most do not allow people over 60 to participate, nor do they allow patients needing multi-level ADR. They are trying to show the FDA how good ADR is and having people in the study that they have known for years to have higher complication rates is not in anybody's best interest. Doctors participating in the FDA trials will not even answer my letters. So I have to rely on published research to get a sense of when it will be my turn for surgery. Right now, I have seen and appreciate very much, the negative outcomes that have been published about the Charite. It appears that many of these patients are going back in because of failure between 6-12 years post surgery. The breakdowns have to do with the polyethylene design of the disk. That concerns me about the Prodisc. I'm waiting to see longitudinal studies that compare Prodisc vs. Maverick before deciding which I would prefer. Then again, perhaps the FDA will not give me that option.

[ans]

Do you have a reference that Charite cores fail significantly after years?

I can think a little bit but this is baffling; there is a leap of faith required. Confusing too is that we often don't know the author's funding source. (I don't know if the NIH has fixed this problem).

I typed Charite alone with other words. There's one interesting European retrospective done with a fuzzy grain - and more.

http://www.ncbi.nlm.nih.gov/entrez/q...arch&DB=pubmed