Journal of neurosurgery. Spine
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Randomized Controlled Trial Multicenter Study
Effect of age on clinical and radiographic outcomes and adverse events following 1-level lumbar arthroplasty after a minimum 2-year follow-up.
Lumbar arthroplasty is approved in the US for the treatment of degenerative disc disease at 1 level in skeletally mature patients. However, a bias toward older patients (> 45 years of age) who are otherwise indicated for the procedure may exist. In this study, the clinical outcomes of patients from the Charité Investigational Device Exemption (IDE) study were analyzed on the basis of patient age. ⋯ Although patients > 45 years of age may have comorbidities or contraindications for arthroplasty for a number of reasons, particularly osteopenia, this analysis demonstrates that patients who are indicated for 1-level arthroplasty experience similar clinical outcome, satisfaction, or adverse events compared with their younger counterparts.
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Randomized Controlled Trial Multicenter Study Comparative Study
Patient selection for lumbar arthroplasty and arthrodesis: the effect of revision surgery in a controlled, multicenter, randomized study.
Patient selection is perhaps the most important factor in successful lumbar surgery. In this study, the authors analyzed the clinical outcomes of patients enrolled in the CHARITE investigational device exemption (IDE) trial who underwent revision surgery after primary total disc replacement with CHARITE or an anterior lumbar interbody fusion (ALIF) with placement of a BAK cage and iliac crest autograft. This revision surgery was either a supplemental posterior lumbar fixation or a 360 degrees fusion. Statistical analysis was conducted to compare clinical success in patients who underwent revision surgery with those who did not. ⋯ The 7.1% of patients who underwent a secondary stabilization procedure had poor clinical improvement. This finding may indicate that if the alternative treatment had been the initial treatment, these patients would not have benefited, and further implies a 7.1% rate of imprecision in preoperative evaluation.
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Randomized Controlled Trial Multicenter Study Comparative Study
Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial.
The authors report the results of a prospective randomized multicenter study in which the results of cervical disc arthroplasty were compared with anterior cervical discectomy and fusion (ACDF) in patients treated for symptomatic single-level cervical degenerative disc disease (DDD). ⋯ The PRESTIGE ST Cervical Disc System maintained physiological segmental motion at 24 months after implantation and was associated with improved neurological success, improved clinical outcomes, and a reduced rate of secondary surgeries compared with ACDF.
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Randomized Controlled Trial Multicenter Study Comparative Study
Quality of life of lumbar stenosis-treated patients in whom the X STOP interspinous device was implanted.
This study was conducted to compare the quality of life (QOL) in patients with neurogenic intermittent claudication (NIC) secondary to lumbar spinal stenosis (LSS). Using the 36-Item Short Form (SF-36) questionnaire, the authors compared the results obtained in patients treated with the X STOP Interspinous Process Decompression (IPD) System with those obtained in patients who underwent nonoperative therapies. ⋯ The results of this study demonstrate that the X STOP device is significantly more effective than nonoperative therapy in improving the QOL in patients with LSS. The results are comparable with those reported in other studies involving traditional decompressive techniques for LSS and suggest that the X STOP implant can provide an effective treatment compared with nonoperative and conventional surgical therapies.
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Randomized Controlled Trial Multicenter Study
Treatment of neurogenic claudication by interspinous decompression: application of the X STOP device in patients with lumbar degenerative spondylolisthesis.
Interspinous process decompression (IPD) theoretically relieves narrowing of the spinal canal and neural foramen in extension and thus reduces the symptoms of neurogenic intermittent claudication (NIC). The purpose of this study was to compare the efficacy of IPD with nonoperative treatment in patients with NIC secondary to degenerative spondylolisthesis. ⋯ The X STOP device was more effective than nonoperative treatment in the management of NIC secondary to degenerative lumbar spondylolisthesis.