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INTERSPINOUS PROCESS DISTRACTOR (X-STOP™) IN LUMBAR SPINAL STENOSIS: A PROSPECTIVE COHORT STUDY



Abstract

The objective of this study was to assess the clinical outcome and efficacy of the X-Stop™ interspinous implant.

67 patients (36 male, 31 female) with mean age of 62.4 years (range 50–94 years) and radiologically proven lumbar stenosis, underwent X-Stop™ implantation during the period of June 2004 to June 2007. Patients were assessed pre-operatively and post-operatively at 3, 6 and 12 months using the Back and Sciatica Questionnaire, the Oswestry Disability and the SF12 questionnaire. Patient’s satisfaction was assessed in each visit. Minimum follow up 2 years in 45 patients and 1 year in 22 patients.

70% had significant improvement in the walking distance following the operation.

With the Back and Sciatica Questionnaire the average preoperative VAS of back and leg pain was 7.1 and 6.7 and improved to 2.5 and 2.6 postoperatively.

86% patient had improvement in their ODI score by 14% and more with average pre and postoperative score 44% (range18%–84%) and 15.8% (range 0%–61%) respectively.

With the SF12 questionnaire 68% patients had significant improvement in physical score and 77% in the mental score. Complications included five superficial wound infections and one wound haematoma. One patient required revision surgery.

This new surgical technique for the treatment of lumbar spinal stenosis, is simple and effective with minimum complications.

Correspondence should be addressed to Sue Woordward, Britspine Secretariat, 9 Linsdale Gardens, Gedling, Nottingham NG4 4GY, England. Email: sue.britspine@hotmail.com