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Disc Replacement of the DDD of the Lumbar Spine

I. Maverick Total Disc Replacement: A prospective study of the first 30 cases with one year follow up (Y. Barzilay, J.C. Le Huec, G.R. Reddy, and T. Friesem, 2004)

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Maverick Total Lumbar Disc Prosthesis was implanted at L4-L5 (18 patients) and L5-S1(12 patients ) following single-level DDD surgery in a sample population consisting 16 females and 14 males (ave: 44 yr) with a follow-up after one year. Pre- and post-operative VAS and ODI, as well as ROM and sagittal balance on a radiographic scale were analyzed.  ODI indicates significant improvement at 82% and86% at 6 mo and 1 yr, whereas VAS indicates improvement from 7.1 ± 2 score (pre-operation) to 3.0 ± 1.8 score (post-operation). Post-operative ROM was 6°±4 with no prosthetic complication and no change in lordosis or associated lumbar parts leading to normal sagittal and spino-pelvic balance for the patients.

II. Artificial Disc Replacement for Degenerative Disc Disease of the Lumbar Spine (Jeffrey A. Tice, M.D.) [Assessment of 4-case series]

            Four case series was assessed for Charité Artificial Disc Replacement Surgery using Technological Assessment criterion: (1) Cinotti et al. 1996 single level disc prosthetics for 46 Italian patients (2) Lemaire, et al. 1997 comparison of different levels of disk implantation (3) Zeeger 1999 two year follow-up of the disc implants; and (4) Sott and Harrison et al. 2000 three year follow up small case series. Although the four-case series have 63-79 % clinical satisfaction which is comparable to lumbar fusion, Tice castigated the four-case series on the lack incomplete reporting of methods, biased (lack of blinding), with no assessment on the adjoining region, and no assessment on long term viability. Tice recommends that the device is not used for DDD treatment since it did not meet TA criteria 3 (evidence permit efficacy), 4 (improve net health outcomes) and 5 (improvement attainable outside investigation).

III. Results of the Prospective, Randomized, Multicenter FDA IDE Study of the ProDisc®-L Total Disc Replacement Versus Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease ( Zigler et al. 2007)

            Sample population consisting of 292 US patients (50 nonrandom and 236 random) with unblinded treatment Seventy-five control received lumbar interbody fusion using commercial available femoral ring allograft and posterolateral fusion with autogenous iliac crest bone graft in conjunction with pedicle screws whereas 144 received ProDisc®-L Total Disc with a single centrally located keel and UHMWPE articulation. All samples have DDD at L3-S1 and have failed conservative therapy indicated for the ailment. Thirty-eight adept surgeons (mostly fellows, and spine experts, were employed and unblinded for the study. The Pro Disc was implanted was initiated by mini-open retroperitoneal approach, followed by complete discectomy removal of posterior osteophytes, cartilaginous endplates and release of posterior longitudinal ligament, and implantation of devised in a collapsed manner. Clinical scores using VAS, 15 pt-ODI, SF-36, ROM, reflexes and tension were evaluated at pre- and post-surgery (1.5, 3, 6, 12, 18, and 24 mo). Results indicate that OD scoring of investigational with 67.8% compared to 54.9% of control; ROM indicates 89.5 % success; VAS 37 ± 30.1 mm for a 39-mm average reduction (investigational); and 0% complications.

IV. Clinical Results of Total Lumbar Disc Replacement With ProDisc II: Three-Year Results for Different Indications (Siepe et al)

            One-hundred ninety-two patients which was subdivided into four groups —DDD without modic changes,  DDD with nucleuolus prelapse, those who have undergone previous discectomy, and DDD with Modic changes —were implanted with Pro-discII. Implantation proceeded as according to the manufacturer’s instructions and disc exposure by mini-open laparotomy. Statistical tool use was t-test analysis and two-tailed Mann-Whitney U-Wilcoxon for group comparison. At 34.2 mo average, those who received treatments indicate significance at P < 0001, with DDD + NPP group having more favorable outcomes. Results also indicate better outcomes for younger patient and those who have received monosegmental replacements. Complications were higher for multi- compared to bisegmental replacements.

V. Complications and reoperations of the SB Charité lumbar disc prosthesis: experience in 75 patients. (Punt et al)

            The samples for the study were 75 patients experiencing sciatic pain and LBP after insertion with Charité lumbar disc prosthesis. Late complications indicated for the samples vary from subsidence, prosthetic wear-out, adjacent discs degeneration, facet joint degeneration and migration of the prosthetics. Fifteen patients received fusion without prosthetic removal, and 22 have prosthetic removals and fusions. VAS and Owestry decreased significantly for each group.

VI. Conclusions

            Except for Tice’s assessment on a four case series and Punt’s complications, all studies were directed in studying the efficacy of disc replacements as compared to fusion technique. The three studies. Tice and Punt’s assessment and studies indicated that SB Charitte lumbar disc prosthesis has unfavorable outcomes whereas ProDisc as indicated by Ziegler and Siepe have significant post-operative results. Punt’ s studies were incredibly fractured because the samples lack standardization and the patient’s post-operative problems were not clearly defined. Zigler’s study turned out to be most fruitful for the disc replacement, but I contend that, the surgeons used for the study were highly-adept professionals. Zigler et al has a well defined samples with comparisons between fusion and disc replacement. What the study(ies) lack is there is the absence of longitudinal analysis or long-term follow up following disc replacement of DDD.

Bibliography

Barzilay,. J.C. Le Huec, G.R. Reddy, and T. Friesem. (2004). Maverick Total Disc Replacement: A prospective study of the first 30 cases with one year follow up. Retrieved February 23, 2008 from
http://proceedings.jbjs.org.uk/cgi/content/abstract/87-B/SUPP_III/238-b

Complications and reoperations of the SB Charité lumbar disc prosthesis: experience in 75 patients. Retrieved February 23, 2008 from
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2226059

Siepe et al. (2006). Clinical Results of Total Lumbar Disc Replacement With ProDisc II: Three-Year Results for Different Indications. Spine. 2006;31(17):1923-1932

Tice, J. A. (2005). Artificial Disc Replacement for Degenerative Disc Disease of the Lumbar Spine. CA: California Technology Assessment Forum.

Zigler J. et al. (2007). Results of the Prospective, Randomized, Multicenter FDA IDE Study of the ProDisc®-L Total Disc Replacement Versus Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease.  Spine. 32(11):1155-1162.

 

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