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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Randomized Controlled Trial Comparative Study
Does Wallis implant reduce adjacent segment degeneration above lumbosacral instrumented fusion?
Delayed complications following lumbar spine fusion may occur amongst which is adjacent segment degeneration (ASD). Although interspinous implants have been successfully used in spinal stenosis to authors' knowledge such implants have not been previously used to reduce ASD in instrumented lumbar fusion. This prospective controlled study was designed to investigate if the implantation of an interspinous implant cephalad to short lumbar and lumbosacral instrumented fusion could eliminate the incidence of ASD and subsequently the related re-operation rate. ⋯ In this series, the Wallis interspinous implant changed the natural history of ASD and saved the two cephalad adjacent unfused vertebra from fusion, while it lowered the radiographic ASD incidence until to 5 years postoperatively. Longer prospective randomized studies are necessary to prove the beneficial effect of the interspinous implant cephalad and caudal to instrumented fusion. We recommend Wallis device for UCLA degeneration I and II.
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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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Multiple myeloma (MM) is a B cell malignancy characterized by important alterations of physiologic bone turnover, wherein increased osteoclastic bone resorption is not accompanied by a comparable increase in bone formation, resulting in diffuse osteopenia, focal lytic lesions, pathologic fractures, hypercalcemia, and bony pain. Consequently, patients with MM frequently require for quality of life's improvement and pain's treatment radiation therapy, surgery, and analgesic medication. Minimally invasive surgical procedures such as the kyphoplasty allows patients with pathological osteolytic vertebral lesions to have immediate improvement in their quality of life. ⋯ Segmental kyphosis angle correction showed a mean decrease of 1.7 degrees (range 0 degrees -2.5 degrees ) at radiographic control at 5-year follow-up, with respect to the immediate postoperative X-ray, although lower than preoperative. The data obtained demonstrated the effectiveness of kyphoplasty in the treatment of vertebral collapse in MM. The results achieved with this minimally invasive technique were clinically and biomechanically satisfactory.