Clinical success for both studies exceeded the study acceptance criteria of 85%. At 1-year follow-up, the flexion-extension range of motion per level: Discectomy and implantation of the device alleviates neurologic symptoms and signs similar to anterior cervical discectomy and fusion. Radiographic evidence supports maintenance of motion. The procedure is safe and the patients recover quickly. At least 5 years of follow-up will be needed to assess the long-term functionality of the prosthesis and protective influence on adjacent levels.
Study design: Prospective, randomized clinical trial. Setting: France. Objectives: To evaluate the safety and e ect on neurological outcome of nimodipine, methylprednisolone, or both versus no medical treatment in spinal-cord injury during the acute phase. Method: One hundred and six patients who had spinal trauma (including 48 with paraplegia and 58 with tetraplegia) were randomly separated into four groups: M=methylprednisolone (30 mg×kg 71 over 1 h, followed by 5.4 mg×kg 71 ×h 71 for 23 h), N=nimodipine (0.015 mg×kg 71 ×h 71 for 2 h followed by 0.03 mg×kg 71 ×h 71 for 7 days), MN (both agents) or P (neither medication). Neurological assessment (ASIA score) was performed by a blinded senior neurologist before treatment and at 1-year follow-up. Early spinal decompression and stabilization was performed as soon as possible after injury. Results: One hundred patients were reassessed at 1 year. Neurological improvement was seen in each group (P50.0001), however no additional neurological bene®t from treatment was observed. Infectious complications occurred more often in patients treated with M. Early surgery (49 patients underwent surgery within 8 h of their accident) did not in¯uence the neurological outcome. The only predictor of the latter was the extent of the spinal injury (complete or incomplete lesion). Conclusion: The present study con®rms the absence of bene®t of pharmacological therapy in this indication. Because of the paucity of clinical studies that demonstrate the e cacy of pharmacological treatment in spinal injury during the acute phase, systematic use of pharmaceutical agents should be reconsidered. Spinal Cord (2000) 38, 71 ± 76
There is a strong association of the occurrence of HO with subsequent loss of movement of the implanted cervical artificial disc. We have found that sex and age are two possible risk factors in the development of HO after cervical disc replacement.
Discectomy and implantation of the device alleviates neurological symptoms and signs similar to anterior cervical discectomy and fusion. Radiographic evidence supports normal range of motion. The procedure is safe and the patients recover quickly. Restrictive postoperative management is not necessary. However, only after long-term follow-up of at least 5 years will it become clear whether the device remains functional, thus confirming these early favorable results. In addition, the influence on adjacent motion segments can be assessed after at least 5 years of follow-up.
The potential for rapid and maintained improvement in clinical outcome and quality of life should be considered when selecting patients with metastatic disease to the spine for surgery rather than basing decisions solely on survival prognostic factors comprising current scoring systems.
Purpose There are few prospective studies on surgical outcomes and survival in patients with metastatic disease to the spine. The magnitude and duration of effect of surgery on pain relief and quality of life remains uncertain. Therefore, the aim of this clinical study was to prospectively evaluate clinical, functional, quality of life and survival outcomes after palliative surgery for vertebral metastases. Methods 118 consecutive patients who underwent spinal surgery for symptomatic vertebral metastases were prospectively followed up for 12 months or until death. Clinical data and data from the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire were obtained pre-and post-operatively and at regular follow-up intervals. Results Surgery was effective in achieving rapid improvement in axial and radicular pain, neurological deficit, sphincteric dysfunction and ambulatory status, with a complication rate of 26% and a 12 month mortality rate of 48%. Almost 50% of patients had complete resolution of back pain, radiculopathy and neurological deficit. Of the patients who were non-ambulant and incontinent, over 50% regained ambulatory ability and recovered urinary continence. The overall incidence of wound infection or breakdown was 6.8% and the local recurrence rate was 8.5%. There was a highly significant improvement in physical, role, cognitive and emotional functioning and global health status post-operatively. Greatest improvement in pain, function and overall quality of life occurred in the early post-operative period and was maintained until death or during the 12 month prospective follow-up period. Conclusion The potential for immediate and prolonged improvement in pain, function and quality of life in patients with symptomatic vertebral metastases should be considered during the decision-making process when selecting and counselling patients for surgery.
To evaluate the long-term effectiveness of a single cervical epidural steroid injection (CESI) performed with or without morphine, 24 patients, without need of surgery, but suffering for more than 12 months from cervical radicular pain, were included in a prospective and randomised study. The cervical epidural space was injected (C7-D1; 18-ga needle) with an increasing volume (10 ml maximum) of isotonic saline solution to exacerbate the patient's radicular pain. The patients were then randomly allocated to 2 groups: the steroid group (group S, n = 14) received an equivalent volume of 0.5% lidocaine plus triamcinolone acetonide (10 mg/ml) and the steroid plus morphine group (group S + M, n = 10) received the same combination plus 2.5 mg of morphine sulphate. Pain relief was assessed as the percentage of pain decrease on a visual analogue scale on day 1 and at months 1, 3, 6, 8 and 12 after CESI, up to 48 months. Anthropometric data between the 2 groups were similar. The mean volume injected in the epidural space was: 6.6 +/- 2.1 and 6.3 +/- 1.9 ml in groups S and S + M, respectively, and this volume exacerbated pain in 21 of 24 patients. Despite observing a better transient improvement the day after CESI in the S + M group, long-term results did not differ. The success rate was 78.5% in group S and 80% in group S + M providing pain relief of 86.8 +/- 14.7% and 86.9 +/- 17.9%, respectively. Pain relief remained stable with time (mean follow-up: 43 +/- 18.1 months).(ABSTRACT TRUNCATED AT 250 WORDS)
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