Five-year results of a clinical pilot study utilizing a pedicle-lengthening osteotomy for the treatment of lumbar spinal stenosis.

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OBJECTIVE Lumbar spinal stenosis (LSS) is a common condition that leads to significant disability, particularly in the elderly. Current therapeutic options have certain drawbacks. This study evaluates the 5-year clinical and radiographic results of a minimally invasive pedicle-lengthening osteotomy (PLO) for symptomatic LSS. METHODS A prospective, single-arm, clinical pilot study was conducted involving 20 patients (mean age 61.7 years) with symptomatic LSS treated by a PLO procedure at 1 or 2 lumbar levels. All patients had symptoms of neurogenic claudication or radiculopathy secondary to LSS, and had not improved after a minimum 6-month course of nonoperative treatment. Eleven patients had a Meyerding grade I degenerative spondylolisthesis in addition to LSS. Clinical outcomes were measured using the Oswestry Disability Index, Zürich Claudication Questionnaire, 12-Item Short Form Health Survey, and a visual analog scale for back and leg pain. Procedural variables, neurological outcomes, adverse events, and radiological imaging (plain radiographs and CT scans) were collected at the 1.5-, 3-, 6-, 9-, 12-, 24-, and 60-month time points. RESULTS The PLOs were performed through percutaneous incisions, with minimal blood loss in all cases. There were no operative complications. Four adverse events occurred during the follow-up period. Statistically significant improvement was observed in each of the outcome instruments and maintained over the 5-year follow-up period. Imaging studies, reviewed by an independent radiologist, showed no evidence of device subsidence, migration, breakage, or heterotopic ossification. Thin-slice CT scans documented healing of the osteotomy site in all patients at the 6-month time point and an increase of 115% in the mean cross-sectional area of the spinal canal. CONCLUSIONS Treatment of patients with symptomatic LSS with a PLO procedure provided substantial enlargement of the area of the spinal canal and favorable clinical results for both disease-specific and non-disease-specific outcome measures at all follow-up time points out to 5 years. Future research is needed to compare this technique to alternative therapies for LSS.