Clinical Results of Total Lumbar Disc Replacement With ProDisc II

Spine Center, OrthoCenter Munich, Munich, Germany.
Spine (Impact Factor: 2.3). 08/2006; 31(17):1923-32. DOI: 10.1097/01.brs.0000228780.06569.e8
Source: PubMed


Prospective study analyzing midterm clinical results of total lumbar disc replacement (ProDisc II) for different indications.
To assess functional outcome after total lumbar disc replacement (TDR) treated for varying indications.
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.
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.
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.
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.

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    • "EURR-6819; No. of Pages 7 C.K. Peterson et al. / European Journal of Radiology xxx (2014) xxx–xxx 3 influence of Modic changes on the outcomes of patients having either lumbar fusion or total lumbar disc replacement reported that the Modic changes did not negatively (or positively) influence the outcomes [19] [20]. A systematic review of the literature published in 2011 could not reach a definite conclusion regarding whether or not Modic changes are associated with treatment outcomes because the available literature was sparse and heterogenous at that time [21]. "
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    ABSTRACT: OBJECTIVE: To compare outcomes after imaging-guided transforaminal lumbar nerve root blocks in MRI confirmed symptomatic disc herniation patients with and without Modic changes (MC). METHODS: Consecutive adult patients with MRI confirmed symptomatic lumbar disc herniations and an imaging-guided lumbar nerve root block injection who returned an outcomes questionnaire are included. Numerical rating scale (NRS) pain data was collected prior to injection and 20-30 min after injection. NRS and overall improvement were assessed using the patient's global impression of change (PGIC) scale at 1 day, 1 week and 1 month post injection. The proportion of patients with and without MC on MRI as well as Modic I and Modic II was calculated. These groups were compared for clinically relevant 'improvement' using the Chi-squared test. Baseline and follow-up NRS scores were compared for the groups using the unpaired t-test. RESULTS: 346 patients are included with MC present in 57%. A higher percentage of patients without MC reported 'improvement' and a higher percentage of patients with MC reported 'worsening' but this did not reach statistical significance. The numerical scores on the PGIC and NRS scales showed that patients with MC had significantly higher pain and worse overall improvement scores at 1 month (p=0.048 and p=0.03) and a significantly lower 1 month NRS change score (p=0.04). CONCLUSIONS: Patients with MRI confirmed symptomatic lumbar disc herniations and MC report significantly lower levels of pain reduction after a lumbar nerve root block compared to patients without MC.
    Full-text · Article · Jun 2014 · European Journal of Radiology
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    • "Two small case studies among patients with chronic LBP showed that patients with M1 changes benefitted from instrumented fusion [4,34]. The presence of MC did not negatively influence the outcome of total lumbar disc replacement among patients with degenerative disc disease [35]. "
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    ABSTRACT: Modic changes (MC) are associated with low back pain (LBP), but effective treatments are lacking. The aim of this randomized, placebo-controlled, double-blinded trial was to evaluate the efficacy of zoledronic acid (ZA) for chronic LBP among patients with MC in magnetic resonance imaging (MRI). Inclusion criteria were LBP lasting >=3 months, with an intensity of >=6 on a 10-cm VAS or an Oswestry Disability Index (ODI) of >=30%, and MC in MRI. Patients were randomized into single intravenous infusion of ZA 5 mg (n = 20), or placebo (n = 20) groups. The primary outcome was LBP intensity, secondary outcomes leg pain intensity, ODI, health-related quality of life (RAND-36), lumbar flexibility, sick leaves and use of pain medication. The treatment differences at one month and one year were analysed using ANCOVA with adjustment for the baseline score. The mean difference (MD) between the groups in the primary outcome, intensity of LBP, was 1.4 (95% confidence intervals (CI) 0.01 to 2.9) in favour of ZA at one month. We observed no significant between-group difference in the intensity of LBP at one year (MD 0.7; 95% CI -1.0 to 2.4) or in secondary outcomes at any time point except that 20% of patients in the ZA group used non-steroidal anti-inflammatory drugs at one year compared to 60% in the placebo group (P = 0.022). Acute phase reactions (fever, flu-like symptoms, arthralgia) emerged in 95% of the patients in the ZA group, compared to 35% in the placebo group. ZA was effective in reducing the intensity of LBP in the short term and in reducing the use of NSAIDs within the time span of one year among patients with chronic LBP and MC confirmed in MRI. Although the results seem encouraging, larger studies are required to analyse the effectiveness and safety of ZA for patients with MC.Trial registration: identifier NCT01330238.
    Full-text · Article · Mar 2014 · BMC Musculoskeletal Disorders
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    • "For instrumented lumbar spinal fusion, several studies indicate that the success rate (based on functional outcomes and pain measurement) is approximately 50%; thus, half of the patients still report signifi cant pain and disability following the surgery ( Button, Gupta, Barrett, Cammack, & Benson, 2005 ; Deyo et al., 2004, 2005 ; Fenton, Mirza, Lahad, Stern, & Deyo, 2007 ; Martin et al., 2007 ). Even newer technologies aimed at improving lumbar fusion outcomes, such as lumbar arthroplasty, have shown failure rates around 20% ( David, 2007 ; McAfee et al., 2006 ; Siepe, Mayer, Wiechert, & Korge, 2006 ). Based on the current data on outcomes related to various forms of LS, many patients report poor outcomes and these poor outcomes might infl uence others to have negative perceptions of LS. "
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    ABSTRACT: Introduction: Studies have shown that lumbar surgery (LS) outcomes may be influenced by perception. However, the perceptions of the general population regarding LS are not known. Therefore, the purpose of this study was to investigate the general population's perceptions regarding LS. SUBJECTS: This study included 262 participants (mean age: 46.1 years; 125 males and 137 females) from the Las Vegas (NV) metropolitan area. METHODS: A questionnaire was developed by an expert panel and was assessed for face and content validity. After revision and establishment of test-retest reliability, participants were surveyed at 12 randomly selected grocery stores in Las Vegas. The questionnaire assessed demographics, personal and family medical history, and 11 items pertaining to perceptions of LS. RESULTS: The participants had a somewhat uncertain expectation about the potential success of LS; however, approximately two-thirds believed that LS is unsuccessful to the point that they would not be able to return to their previous level of activity after LS. Of the questions dealing with success of LS, the neutral response had the greatest frequency suggesting a lack of knowledge or uncertainty about LS. More than half of the respondents were fearful of LS and anticipated a protracted recovery accompanied by undesired side effects. Three quarters of the respondents agreed that they would try all other means of treatment before opting for LS, yet 39% said that they would undergo LS if they had severe lower back pain (LBP). CONCLUSIONS: The general population has an uncertain view of LS outcomes and anticipates postoperative side effects and a protracted recovery; these views may explain why a majority of participants expressed fear of LS and why most would only opt for LS as a last resort. This uncertainty and anticipation of poor outcomes may be a strong contributor to preoperative fear and anxiety, which could deleteriously influence postoperative outcomes.
    Full-text · Article · Sep 2013 · Orthopaedic Nursing
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