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Reduction of leg pain and lower-extremity weakness for 1 year with Oxiplex/SP gel following laminectomy, laminotomy, and discectomy.

OBJECT: Although good surgical technique is effective in reducing postoperative epidural fibrosis, compression or tethering of the nerve root may cause recurrent radicular pain and physical impairment. The implantation of a bioresorbable gel on the dura may further decrease the amount of scar formation after surgery and thus improve the patient's ability to perform activities of daily living (ADL). This study is a 12-month evaluation of the safety and effectiveness of Oxiplex/SP Gel (FzioMed, Inc., San Luis Obispo, CA) in the reduction of pain and radiculopathy after lumbar discectomy. METHODS: A pilot randomized single-blind multicenter clinical trial was conducted to evaluate the performance of Oxiplex/SP Gel in patients who underwent surgery for unilateral herniation of the lumbar disc at L4-5 or L5-S1. Eighteen patients with severe leg pain and lower-extremity weakness (11 women and seven men) were randomly assigned intraoperatively to receive the gel at the conclusion of surgery (treatment group) or to undergo surgery alone (control group). Self-assessment questionnaires (Lumbar Spine Outcomes Questionnaire) to assess pain, symptoms, and ADL were completed preoperatively and at scheduled postoperative intervals (30 days, 90 days, 6 months, and 12 months). The authors examined the spine and lower extremities of patients scheduled for discectomy to assess neurological function and pain. Treated patients received sufficient Oxiplex/SP Gel (1-3 ml) to coat the nerve root and fill the epidural space. Postoperative clinical evaluations were performed at 30 and 90 days. Patients completed the self-assessment questionnaires at baseline and were contacted by telephone or mail for the completion of the postoperative self-assessment questionnaires. Surgical procedures were well tolerated; no device-related adverse events and no clinically significant laboratory results were reported. The 11 patients with severe leg pain and lower-extremity weakness who were treated with Oxiplex/SP Gel had a reduction in those symptoms at 30 days, 90 days, 6 months, and 12 months after discectomy, compared with the seven control patients who underwent surgery only. CONCLUSIONS: Oxiplex/SP Gel was easy to use and safe in patients who underwent unilateral discectomy. A greater benefit in clinical outcome measures was seen over the 12-month follow-up period in gel-treated patients.

Activities of Daily Living↗

Clinical outcomes and radiological instability following decompressive lumbar laminectomy for degenerative spinal stenosis: a comparison of patients undergoing concomitant arthrodesis versus decompression alone.

One hundred twenty-four patients with degenerative lumbar stenosis underwent decompression with fusion (32 patients) and without fusion (92 patients) during a 30-month period between 1986 and 1988. Patient-reported satisfaction at a mean follow-up period of 5.8 years (range 4.6-6.8 years) revealed a 79% good or fair outcome and a 21% poor outcome (26 patients). Seven patients (6%) developed lumbar instability, three patients (2%) developed new stenosis at an adjacent unoperated level, and three patients (2%) developed a new disc herniation between 2 and 5 years after surgery. Progressive postoperative spondylolisthesis occurred in 31% of patients with normal preoperative alignment (mean 7.8 mm, range 2-20 mm) and in 73% of patients with preoperative subluxation (mean 5.1 mm, range 2-13 mm) in whom fusion was not attained. Radiological progression did not correlate well with patient-reported outcome. The major conclusions from this study are the following: 1) the majority of patients respond well to this surgery, but complication (22%) and late deterioration (10%) rates are not insignificant; 2) radiological instability is common after decompression for degenerative lumbar spinal stenosis, but this correlates poorly with clinical outcome; 3) there are no definitive clinical or radiological factors that preoperatively predict patients at risk for a poor outcome; 4) post-operative radiological instability is more likely to occur when the following criteria are present: preoperative spondy-degenerated L-4 or a markedly degenerated L-3 disc; and when a radical and extensive decompression greater than one level is planned; and 5) the group at greatest risk for a poor outcome consists of those patients with normal preoperative alignment who do not suffer slippage following surgery.

Adult↗

Conus medulla-cauda compression from nerve root hypertrophy in a child with Dejerine-Sottas syndrome: improvement with laminectomy and duraplasty. Case report.

This 7-year-old boy with Dejerine-Sottas syndrome caused by a mutation in the myelin protein zero gene began to suffer rapid deterioration with increasing leg weakness, loss of the ability to ambulate, and bowel and bladder incontinence. Magnetic resonance imaging of the spine revealed nerve root hypertrophy resulting in compression of the conus medullaris and cauda equina. Decompressive surgery was successful in reversing some of his deficits.

Amino Acid Substitution↗