A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1-year results.

Patients suffering from neurogenic intermittent claudication secondary to lumbar spinal stenosis have historically been limited to a choice between a decompressive laminectomy with or without fusion or a regimen of non-operative therapies. The X STOP Interspinous Process Distraction System (St. Francis Medical Technologies, Concord, Calif.), a new interspinous implant for patients whose symptoms are exacerbated in extension and relieved in flexion, has been available in Europe since June 2002. This study reports the results from a prospective, randomized trial of the X STOP conducted at nine centers in the U.S. Two hundred patients were enrolled in the study and 191 were treated; 100 received the X STOP and 91 received non-operative therapy (NON OP) as a control. The Zurich Claudication Questionnaire (ZCQ) was the primary outcomes measurement. Validated for lumbar spinal stenosis patients, the ZCQ measures physical function, symptom severity, and patient satisfaction. Patients completed the ZCQ upon enrollment and at follow-up periods of 6 weeks, 6 months, and 1 year. Using the ZCQ criteria, at 6 weeks the success rate was 52% for X STOP patients and 10% for NON OP patients. At 6 months, the success rates were 52 and 9%, respectively, and at 1 year, 59 and 12%. The results of this prospective study indicate that the X STOP offers a significant improvement over non-operative therapies at 1 year with a success rate comparable to published reports for decompressive laminectomy, but with considerably lower morbidity.

Postoperative synergistic gangrene after spinal fusion.

STUDY DESIGN: A case of synergistic necrotizing gangrenous fasciitis after spinal surgery is reported. OBJECTIVES: To describe this unusual complication, explain the rationale of treatment, and increase awareness of this serious postoperative complication. SUMMARY OF BACKGROUND DATA: Although several cases of postoperative synergistic necrotizing fasciitis have been reported, there are no previously reported cases of this condition after spinal surgery. METHODS: A rapidly progressive necrotizing spinal wound infection after fusion for degenerative disc disease was treated in a 39-year-old man. RESULTS: The infection was successfully treated with serial debridements, appropriate antibiotics, and hyperbaric wound oxygenation. CONCLUSIONS: The authors suggest adherence to the fundamental principles of treatment including radical surgical debridement and appropriate antibiosis for necrotizing gangrene after spinal surgery. In evaluation of aggressive spinal wound infections, diagnosis of synergistic necrotizing fasciitis should be kept in mind. Although hyperbaric wound oxygenation was implemented as an adjunct and appeared to aid in controlling the infection, its effect on outcome is not clear.