Quality of systematic reviews: an example of studies comparing artificial disc replacement with fusion in the cervical spine.

Cervical artificial disc replacement (C-ADR) is now an alternative to anterior cervical discectomy and fusion (ACDF). Many studies have evaluated the efficacy of C-ADR compared with ACDF. This led to a series of systematic reviews and meta-analyses to evaluate the evidence of the superiority of one intervention against the other. The aim of the study presented here was to evaluate the quality of these reviews and meta-analyses. Medline via Ovid, Embase, and Cochrane Library were searched using the keywords: (total disk replacement, prosthesis, implantation, discectomy, and arthroplasty) AND (cervical vertebrae, cervical spine, and spine) AND (systematic reviews, reviews, and meta-analysis). Screening and data extraction were conducted by two reviewers independently. Two reviewers then assessed the quality of the selected reviews and meta-analysis using 11-item AMSTAR score which is a validated measurement tool to assess the methodological quality of systematic reviews. Screening of full reports of 46 relevant abstracts resulted in the selection of 15 systematic reviews and/or meta-analyses as eligible for this study. The two reviewers' inter-rater agreement level was high as indicated by kappa of >0.72. The AMSTAR score of the reviews ranged from 3 to 11. Only one study (a Cochrane review) scored 100% (AMSTAR 11). Five studies scored below (AMSTAR 5) indicating low-quality reviews. The most significant drawbacks of reviews of a score below 5 were not using an extensive search strategy, failure to use the scientific quality of the included studies appropriately in formulating a conclusion, not assessing publication bias, and not reporting the excluded studies. With a significant exception of a Cochrane review, the methodological quality of systematic reviews evaluating the evidence of C-ADR versus ACDF has to be improved

Total disc replacement surgery for symptomatic degenerative lumbar disc disease: a systematic review of the literature

The objective of this study is to evaluate the effectiveness and safety of total disc replacement surgery compared with spinal fusion in patients with symptomatic lumbar disc degeneration. Low back pain (LBP), a major health problem in Western countries, can be caused by a variety of pathologies, one of which is degenerative disc disease (DDD). When conservative treatment fails, surgery might be considered. For a long time, lumbar fusion has been the “gold standard” of surgical treatment for DDD. Total disc replacement (TDR) has increased in popularity as an alternative for lumbar fusion. A comprehensive systematic literature search was performed up to October 2008. Two reviewers independently checked all retrieved titles and abstracts, and relevant full text articles for inclusion. Two reviewers independently assessed the risk of bias of included studies and extracted relevant data and outcomes. Three randomized controlled trials and 16 prospective cohort studies were identified. In all three trials, the total disc replacement was compared with lumbar fusion techniques. The Charité trial (designed as a non-inferiority trail) was considered to have a low risk of bias for the 2-year follow up, but a high risk of bias for the 5-year follow up. The Charité artificial disc was non-inferior to the BAK® Interbody Fusion System on a composite outcome of “clinical success” (57.1 vs. 46.5%, for the 2-year follow up; 57.8 vs. 51.2% for the 5-year follow up). There were no statistically significant differences in mean pain and physical function scores. The Prodisc artificial disc (also designed as a non-inferiority trail) was found to be statistically significant more effective when compared with the lumbar circumferential fusion on the composite outcome of “clinical success” (53.4 vs. 40.8%), but the risk of bias of this study was high. Moreover, there were no statistically significant differences in mean pain and physical function scores. The Flexicore trial, with a high risk of bias, found no clinical relevant differences on pain and physical function when compared with circumferential spinal fusion at 2-year follow up. Because these are preliminary results, in addition to the high risk of bias, no conclusions can be drawn based on this study. In general, these results suggest that no clinical relevant differences between the total disc replacement and fusion techniques. The overall success rates in both treatment groups were small. Complications related to the surgical approach ranged from 2.1 to 18.7%, prosthesis related complications from 2.0 to 39.3%, treatment related complications from 1.9 to 62.0% and general complications from 1.0 to 14.0%. Reoperation at the index level was reported in 1.0 to 28.6% of the patients. In the three trials published, overall complication rates ranged from 7.3 to 29.1% in the TDR group and from 6.3 to 50.2% in the fusion group. The overall reoperation rate at index-level ranged from 3.7 to 11.4% in the TDR group and from 5.4 to 26.1% in the fusion group. In conclusion, there is low quality evidence that the Charité is non-inferior to the BAK cage at the 2-year follow up on the primary outcome measures. For the 5-year follow up, the same conclusion is supported only by very low quality evidence. For the ProDisc, there is very low quality evidence for contradictory results on the primary outcome measures when compared with anterior lumbar circumferential fusion. High quality randomized controlled trials with relevant control group and long-term follow-up is needed to evaluate the effectiveness and safety of TDR

Biomechanical effects of polyaxial pedicle screw fixation on the lumbosacral segments with an anterior interbody cage support

BACKGROUND: Lumbosacral fusion is a relatively common procedure that is used in the management of an unstable spine. The anterior interbody cage has been involved to enhance the stability of a pedicle screw construct used at the lumbosacral junction. Biomechanical differences between polyaxial and monoaxial pedicle screws linked with various rod contours were investigated to analyze the respective effects on overall construct stiffness, cage strain, rod strain, and contact ratios at the vertebra-cage junction. METHODS: A synthetic model composed of two ultrahigh molecular weight polyethylene blocks was used with four titanium pedicle screws (two in each block) and two rods fixation to build the spinal construct along with an anterior interbody cage support. For each pair of the construct fixed with polyaxial or monoaxial screws, the linked rods were set at four configurations to simulate 0°, 7°, 14°, and 21° lordosis on the sagittal plane, and a compressive load of 300 N was applied. Strain gauges were attached to the posterior surface of the cage and to the central area of the left connecting rod. Also, the contact area between the block and the cage was measured using prescale Fuji super low pressure film for compression, flexion, lateral bending and torsion tests. RESULTS: Our main findings in the experiments with an anterior interbody cage support are as follows: 1) large segmental lordosis can decrease the stiffness of monoaxial pedicle screws constructs; 2) polyaxial screws rather than monoaxial screws combined with the cage fixation provide higher compression and flexion stiffness in 21° segmental lordosis; 3) polyaxial screws enhance the contact surface of the cage in 21° segmental lordosis. CONCLUSION: Polyaxial screws system used in conjunction with anterior cage support yields higher contact ratio, compression and flexion stiffness of spinal constructs than monoaxial screws system does in the same model when the spinal segment is set at large lordotic angles. Polyaxial pedicle screw fixation performs nearly equal percentages of vertebra-cage contact among all constructs with different sagittal alignments, therefore enhances the stabilization effect of interbody cages in the lumbosacral area

Influence of preoperative nucleus pulposus status and radiculopathy on outcomes in mono-segmental lumbar total disc replacement: results from a nationwide registry

Background: Currently, herniated nucleus pulposus (HNP) with radiculopathy and other preconditions are regarded as relative or absolute contraindications for lumbar total disc replacement (TDR). In Switzerland it is left to the surgeon's discretion when to operate. The present study is based on the dataset of SWISSspine, a governmentally mandated health technology assessment registry. We hypothesized that preoperative nucleus pulposus status and presence or absence of radiculopathy has an influence on clinical outcomes in patients treated with mono-segmental lumbar TDR. Methods. Between March 2005 and April 2009, 416 patients underwent mono-segmental lumbar TDR, which was documented in a prospective observational multicenter mode. The data collection consisted of perioperative and follow-up data (physician based) and clinical outcomes (NASS, EQ-5D). Patients were divided into four groups according to their preoperative status: 1) group degenerative disc disease ("DDD"): 160 patients without HNP and no radiculopathy, classic precondition for TDR; 2) group "HNP-No radiculopathy": 68 patients with HNP but without radiculopathy; 3) group "Stenosis": 73 patients without HNP but with radiculopathy, and 4) group "HNP-Radiculopathy": 132 patients with HNP and radiculopathy. The groups were compared regarding preoperative patient characteristics and pre- and postoperative VAS and EQ-5D scores using general linear modeling. Results: Demographics in all four groups were comparable. Regarding the improvement of quality of life (EQ-5D) there were no differences across the four groups. For the two main groups DDD and HNP-Radiculopathy no differences were found in the adjusted postoperative back- and leg pain alleviation levels, in the stenosis group back- and leg pain relief were lower. Conclusions: Despite higher preoperative leg pain levels, outcomes in lumbar TDR patients with HNP and radiculopathy were similar to outcomes in patients with the classic indication; this because patients with higher preoperative leg pain levels benefit from a relatively greater leg pain alleviation. The group with absence of HNP but presence of radiculopathy showed considerably less benefits from the operation, which is probably related to ongoing degenerative processes of the posterior segmental structures. This observational multicenter study suggests that the diagnoses HNP and radiculopathy, combined or alone, may not have to be considered as absolute or relative contraindications for mono-segmental lumbar TDR anymore, whereas patients without HNP but with radiculopathy seem to be suboptimal candidates for the procedure. © 2011 Zweig et al; licensee BioMed Central Ltd

Complications and reoperations of the SB Charité lumbar disc prosthesis: experience in 75 patients

Artificial disc prosthesis show fair to good short- and mid-term results. Long-term results are becoming apparent now, however, the incidence of late complications with this procedure remain poorly understood. In this report we will analyse late complications and discuss our experiences with salvage operations in patients with persistent pain after SB Charité disc prosthesis implantation. Seventy-five patients with persistent leg and back pain after insertion of an artificial disc prosthesis were enrolled in the study. In this negative selection frequently occurring late-complications were subsidence, wear, adjacent disc degeneration, facet joint degeneration and migration. In 15 patients we performed a posterior fusion without disc removal, and in 22 patients we removed 26 prostheses and performed a posterior and anterior fusion. The visual analogue scale (VAS) and Oswestry were examined before the salvage operation and after a follow-up period of at least 1 year, which is not yet available in all patients. The VAS and Oswestry decreased in the posterior group (n = 10) respectively from 8.0 (SD 0.9) to 6.3 (SD 2.1) and from 57.0 (SD 17.0) to 44.6 (SD 20.4); and in the disc removal group (n = 14) respectively from 8.0 (SD 0.9) to 5.6 (SD 2.7) and from 56.3 (SD 14.0) to 43.0 (SD 20.7). Serious late complications may occur following total disc replacement. Removal of the SB Charité artificial disc is feasible but with inherent risks. Removal of the disc prosthesis gives slightly better results than posterior fusion alone after a follow-up of at least 1 year