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
-
Randomized Controlled Trial
Anterior cervical fusion with interbody cage containing beta-tricalcium phosphate augmented with plate fixation: a prospective randomized study with 2-year follow-up.
A variety of bone graft substitutes, interbody cages, and anterior plates have been used in cervical interbody fusion, but no controlled study was conducted on the clinical performance of beta-tricalcium phosphate (beta-TCP) and the effect of supplemented anterior plate fixation. The objective of this prospective, randomized clinical study was to evaluate the effectiveness of implanting interbody fusion cage containing beta-TCP for the treatment of cervical radiculopathy and/or myelopathy, and the fusion rates and outcomes in patients with or without randomly assigned plate fixation. Sixty-two patients with cervical radiculopathy and/or myelopathy due to soft disc herniation or spondylosis were treated with one- or two-level discectomy and fusion with interbody cages containing beta-TCP. ⋯ No difference (P > 0.05) was found regarding improvement in spinal curvature as well as neck and arm pain, and recovery rate of JOA score at all time intervals between the two groups. Based on the findings of this study, interbody fusion cage containing beta-TCP following one- or two-level discectomy proved to be an effective treatment for cervical spondylotic radiculopathy and/or myelopathy. Supplemented anterior plate fixation can promote interbody fusion and prevent cage subsidence but do not improve the 2-year outcome when compared with those treated without anterior plate fixation.
-
Randomized Controlled Trial
Physical therapy plus general practitioners' care versus general practitioners' care alone for sciatica: a randomised clinical trial with a 12-month follow-up.
A randomised clinical trial in primary care with a 12-months follow-up period. About 135 patients with acute sciatica (recruited from May 2003 to November 2004) were randomised in two groups: (1) the intervention group received physical therapy (PT) added to the general practitioners' care, and (2) the control group with general practitioners' care only. To assess the effectiveness of PT additional to general practitioners' care compared to general practitioners' care alone, in patients with acute sciatica. ⋯ No significant differences regarding leg pain, functional status, fear of movement and health status were found at short-term or long-term follow-up. At 12 months follow-up, evidence was found that PT added to general practitioners' care is only more effective regarding GPE, and not more cost-effective in the treatment of patients with acute sciatica than general practitioners' care alone. There are indications that PT is especially effective regarding GPE in patients reporting severe disability at presentation.
-
Randomized Controlled Trial
Predictive factors for long-term outcome of anterior cervical decompression and fusion: a multivariate data analysis.
We conducted a prospective randomized study to investigate predictive factors for short- and long-term outcome of anterior cervical decompression and fusion (ACDF) as measured by current pain intensity on the Visual Analogue Scale (VAS) and by disability using the Neck Disability Index (NDI). Current understanding about how preoperative and short-term outcome data predict long-term outcome is sparse, and there are few studies involving analysis of short-term follow-up using multivariate approaches with quantification of the relative importance of each variable studied. A total of 95 patients were randomly allocated for ACDF with the cervical intervertebral fusion cage or the Cloward procedure. ⋯ Radiologically detected findings and surgical technique used were mainly insignificant as predictors. We suggest that the inclusion criteria for ACDF should be based on a bio-psycho-social model including NDI. NDI may also be regarded as an important outcome measurement in evaluation of ACDF.
-
Randomized Controlled Trial
The positive effect of posterolateral lumbar spinal fusion is preserved at long-term follow-up: a RCT with 11-13 year follow-up.
Few studies have investigated the long-term effect of posterolateral lumbar spinal fusion on functional outcome. ⋯ Improvement in functional outcome is preserved for 10 or more years after posterolateral lumbar spinal fusion. No difference between instrumented fusion and non-instrumented fusion was observed. Patients who have to retired due to low back pain have the smallest improvement.
-
Randomized Controlled Trial Comparative Study
Midterm outcome after unilateral approach for bilateral decompression of lumbar spinal stenosis: 5-year prospective study.
The aim of our study is to evaluate the results and effectiveness of bilateral decompression via a unilateral approach in the treatment of degenerative lumbar spinal stenosis. We have conducted a prospective study to compare the midterm outcome of unilateral laminotomy with unilateral laminectomy. One hundred patients with 269 levels of lumbar stenosis without instability were randomized to two treatment groups: unilateral laminectomy (Group 1), and laminotomy (Group 2). ⋯ The ODI scores decreased significantly in both early and late follow-up evaluations and the SF-36 scores demonstrated significant improvement in late follow-up results in our series. Analysis of clinical outcome showed no statistical differences between two groups. For degenerative lumbar spinal stenosis unilateral approaches allowed sufficient and safe decompression of the neural structures and adequate preservation of vertebral stability, resulted in a highly significant reduction of symptoms and disability, and improved health-related quality of life.