SIZE study: study protocol of a multicentre, randomised controlled trial to compare the effectiveness of an interarcuair decompression versus extended decompression in patients with intermittent neurogenic claudication caused by lumbar spinal stenosis.

INTRODUCTION

Intermittent neurogenic claudication (INC) is often caused by lumbar spinal stenosis (LSS). Laminectomy is considered a frequently used surgical technique for LSS. Previous studies have shown that laminectomy can potentially cause lumbar instability. Less invasive techniques, preserving midline structures including the bilateral small size interarcuair decompression, are currently applied. Due to lack of evidence and consensus, surgeons have to rely on their training and own experiences to choose the best surgical techniques for their patients. Hence, an observer and patient blinded multicentre, randomised controlled trial was designed to determine the effectiveness and cost-effectiveness of bilateral interarcuair decompression versus laminectomy for LSS.

METHODS AND ANALYSIS

174 patients above 40 years with at least 12 weeks of INC will be recruited. Patients are eligible for inclusion if they have a clinical indication for surgery for INC with an MRI showing signs of LSS. Patients will be randomised to laminectomy or bilateral interarcuair decompression. The primary outcome is functional status measured with the Roland-Morris Disability Questionnaire at 12 months. Secondary outcomes consist of pain intensity, self-perceived recovery, functional status measured with the Oswestry Disability Index and a physical examination. Outcome measurement moments will be scheduled at 3 and 6 weeks, and at 3, 6, 12, 18, 24, 36 and 48 months after surgery. Physical examination will be performed at 6 weeks, and 12, 24 and 48 months. An economic evaluation will be performed and questionnaires will be used to collect cost data.

ETHICS AND DISSEMINATION

The Medical Ethical Committee of the Erasmus Medical Centre Rotterdam approved this study (NL.65826.078.18). The results will be published in an international peer-reviewed journal.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov (NCT03480893).

IRB APPROVAL STATUS

MEC-2018-093.