European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
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Multicenter Study
SWISSspine: a nationwide registry for health technology assessment of lumbar disc prostheses.
SWISSspine is a so-called pragmatic trial for assessment of safety and efficiency of total disc arthroplasty (TDA). It follows the new health technology assessment (HTA) principle of "coverage with evidence development". It is the first mandatory HTA registry of its kind in the history of Swiss orthopaedic surgery. ⋯ Nevertheless, no prediction about the long-term goals of TDA can be made yet. The SWISSspine registry proofs to be an excellent tool for collection of observational data in a nationwide framework whereby advantages and deficits of its design must be considered. It can act as a model for similar projects in other health-care domains.
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Comparative Study Clinical Trial
Comparison of single-level L4-L5 versus L5-S1 lumbar disc replacement: results and prognostic factors.
The aim of our prospective non-randomized clinical study was to analyze operative data, short-term results, safety, efficacy, complications, and prognostic factors for single-level total lumbar disc replacement (TLDR), and to compare results between different levels (L4-L5 vs. L5-S1). Thirty-six patients with single-level L4-L5 or L5-S1 TLDR, with 1-year minimum follow-up (FU), had complete clinical [SF36, visual analog scale (VAS), Oswestry Disability Index (ODI)] and radiological data, and were included in our study. ⋯ Hospital stay was affected by level (P = 0.036) and pre-op VAS (P = 0.006), while complications were affected by the level (P = 0.000) and pre-op ODI (P = 0.049). Complete pre-operative assessment (in particular VAS and ODI questionnaires) is important because more debilitating patients will have more hospital stay and higher complications or complaints. Patients had to be informed that complications, possibly severe, are particularly frequent (80.6%).
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The dynamic stabilization of lumbar spine is a non-fusion stabilization system that unloads the disc without the complete loss of motion at the treated motion segment. Clinical outcomes are promising but still not definitive, and the long-term effect on instrumented and adjacent levels is still a matter of discussion. Several experiments have been devised in order to gain a better understanding of the effect of the device on the intervertebral disc. ⋯ Pfirrmann scale could not detect any change, while dGEMRIC data already showed a general improvement in the instrumented levels: GAG was increased in 61% of the instrumented levels, while 68% of the non-instrumented levels showed a decrease in GAG, mainly in the posterior disc portion. In particular, seriously GAG-depleted discs seemed to have the greatest benefit from the Dynesys implantation, whereas less degenerated discs underwent a GAG depletion. dGEMRIC was able to visualize changes in both instrumented and non-instrumented levels. Our results suggest that the dynamic stabilization of lumbar spine is able to stop and partially reverse the disc degeneration, especially in seriously degenerated discs, while incrementing the stress on the adjacent levels, where it induces a matrix suffering and an early degeneration.
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Grob et al. (Eur Spine J 5:281-285, 1996) illustrated a new fixation technique in inveterate cases of grade 2-3 spondylolisthesis (degenerative or spondylolytic): a fusion without reduction of the spondylolisthesis. Fixation of the segment was achieved by two cancellous bone screws inserted bilaterally through the pedicles of the lower vertebra into the body of the upper slipped vertebra. Since 1998 we have been using this technique according to the authors' indications: symptomatic spondylolisthesis with at least 25% anterior slippage and advanced disc degeneration. ⋯ No cases of pseudoarthrosis and immediate or late superficial or deep infection were observed. The analysis of the long-term results of the spondylolisthesis surgical treatment with direct pediculo-body screw fixation and postero-lateral fusion gave a very satisfactory response. The technique is reliable in allowing an optimal primary stability, creating the best biomechanical conditions to obtain a solid fusion.
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The most common cervical abnormality associated with rheumatoid arthritis (RA) is atlantoaxial subluxation, and atlantoaxial transarticular screw fixation has proved to be one of the most reliable, stable fixation techniques for treating atlantoaxial subluxation. Following C1-C2 fixation, however, subaxial subluxation reportedly can bring about neurological deterioration and require secondary operative interventions. Rheumatoid patients appear to have a higher risk, but there has been no systematic comparison between rheumatoid and non-rheumatoid patients. ⋯ Furthermore, anterior subluxation aggravation was significantly correlated with the perioperative atlantoaxial and C2-C7 angle changes, and these two changes were strongly correlated to each other. In conclusion, after atlantoaxial transarticular screw fixation, rheumatoid patients have a greater risk of developing subaxial subluxations. The increase of the atlantoaxial angel at the operation can lead to a decrease in the C2-C7 angle, followed by anterior subluxation of the upper cervical spine and possibly neurological deterioration.