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 Clinical Trial
Intermediate clinical and radiological results of cervical TDR (Mobi-C) with up to 2 years of follow-up.
The interest in cervical total disc replacement (TDR) as an alternative to the so-far gold standard in the surgical treatment of degenerative disc disease (DDD), e.g anterior cervical discectomy and fusion (ACDF), is growing very rapidly. Many authors have established the fact that ACDF may result in progressive degeneration in adjacent segments. On the contrary, but still theoretically, preservation of motion with TDR at the surgically treated level may potentially reduce the occurrence of adjacent-level degeneration (ALD). ⋯ Finally, after 2 years, 91% of the patients assume that they would undergo the procedure again. These intermediate results of TDR with Mobi-C are very encouraging and seem to confirm the efficacy and the safety of the device. Regarding the preservation of the status of the adjacent levels, the results of this unconstrained device are encouraging, but longer FU studies are needed to prove it.
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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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Multicenter Study Comparative Study Clinical Trial
Comparison of kyphoplasty with use of a calcium phosphate cement and non-operative therapy in patients with traumatic non-osteoporotic vertebral fractures.
One of the current standard treatment options for younger patients with stable traumatic vertebral fractures is conservative treatment using braces. Kyphoplasty as a minimally invasive procedure has been shown to be effective in stabilizing vertebral body fractures, resulting in immediate pain relief and improved physical function. The purpose of this prospective study was to clarify whether patients with acute traumatic vertebral fractures benefit more from kyphoplasty or from conservative treatment with a brace. ⋯ However, there are clinically asymptomatic cement leakages in up to 45% of which we do not know the consequences in long term. Every patient with traumatic vertebral body fracture treated by kyphoplasty has to be informed about that. Long-time results are outstanding and our findings require confirmation by randomized controlled trials.
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Randomized Controlled Trial Multicenter Study
Timing of surgery for sciatica: subgroup analysis alongside a randomized trial.
Surgery speeds up recovery for sciatica. Prolonged conservative care with surgery for those patients with persistent sciatica however, yields similar results at 1 year. To investigate whether baseline variables modify the difference in recovery rates between these treatment strategies, baseline data of 283 patients enrolled in a randomized trial, comparing early surgery with prolonged conservative care, were used to analyse effect modification of the allotted treatment strategy. ⋯ In a Cox model we estimated a hazard ratio (HR, surgery versus conservative) of 2.2 (95% CI 1.7-3.0) in favour of surgery when sciatica was provoked by sitting, while the HR was 1.3 (95% CI 0.8-2.2) when this sign was absent. The interaction effect is marginally significant (interactions are usually tested at the 10% level) but the patterns generated by the repeated measurement analyses of all primary outcomes are completely consistent with the inferred pattern from the survival analysis. Classical signs did not show any contribution as decision support tools in deciding when to operate for sciatica, whereas treatment effects of early surgery are emphasized when sciatica is provoked by sitting and negligible when this symptom is absent.
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Multicenter Study Comparative Study Clinical Trial
Single-level cervical radiculopathy: clinical outcome and cost-effectiveness of four techniques of anterior cervical discectomy and fusion and disc arthroplasty.
Although there are several accepted methods of surgical treatment for single-level cervical radiculopathy, the choice depend on the surgeon's preference. The techniques may vary in peri-operative morbidity, short- and long-term outcome, but no study so far has analyzed their cost-effectiveness. This study might give some insight in balancing cost and effectiveness and deciding the right technique. ⋯ Anterior cervical discectomy and fusion is an established surgical treatment for cervical radiculopathy. Single-level cervical radiculopathy was treated with four different techniques. The clinical outcome and cost-effectiveness were compared in this study.