Abstract
BackgroundAdvances in minimally invasive surgery have expanded the indications for interlaminar full-endoscopic discectomy. Although the clinical outcomes for this approach may be equivalent to those of conventional microscopic discectomy, the supporting evidence is based on small, single-center, prospective, and retrospective studies. Therefore, a multicenter, randomized controlled trial is warranted.MethodsThis will be a prospective, multicenter, randomized controlled trial comparing the efficacy and safety of interlaminar full-endoscopic discectomy to those of conventional microscopic discectomy. The trial will enroll 100 participants with a lumbar disc herniation, 50 in each group. The primary outcome will be the Oswestry Disability Index (ODI) score at 12 months post-surgery. Secondary outcomes will be: back and leg pain (visual analog scale); the ODI; the EuroQol-5-Dimension score; patient satisfaction; and walking distance/time and time to return to daily activities post-surgery. Surgical outcomes will include postoperative drainage, operative time, duration of hospital stay, postoperative creatine kinase level as an indicator of muscle injury, and postoperative scarring. Postoperative magnetic resonance imaging, computed tomography, and simple radiography will be performed to evaluate radiographic outcomes between the two surgical approaches. Surgery-related complications and adverse effects will be evaluated as safety outcomes. A single assessor at each participating hospital, blinded to group allocation, will assess the enrolled participants at baseline, 2 weeks and 3, 6, and 12 months postoperatively.DiscussionThis trial is designed to determine whether interlaminar full-endoscopic discectomy is clinically comparable to microscopic discectomy to treat lumbar disc herniations. All efforts will be made to reduce bias, including adequate sample sizes, blinded analyses, and multicenter prospective registration. The outcomes will inform practice, providing the evidence needed for the use of interlaminar full-endoscopic over microscopic discectomy by confirming the potential of this technique to improve patient satisfaction and clinical outcomes.Trial registrationClinical Research Information Service; cris.nih.go.kr. (KCT0006277); protocol version (v1, June 8, 2021)
Reply to the letter to the editor of R. Q. Knight concerning “Does minimally invasive lumbar disc surgery result in less muscle injury than conventional surgery? A randomized controlled trial” by M. Arts, R. Brand, et al. (2011) Eur Spine J 20(1):51–57. doi:10.1007/s00586-012-2491-9
