The effectiveness of percutaneous endoscopic decompression compared with open decompression and fusion for lumbar spinal stenosis: protocol for a multicenter, prospective, cohort study

Shuheng Zhai, Wenkui Zhao, Bin Zhu, Xin Huang, Chen Liang, Bao Hai, Lixiang Ding, Hongwei Zhu, Xianhai Wang, Feng Wei, Hongling Chu, Xiaoguang Liu, Shuheng Zhai, Wenkui Zhao, Bin Zhu, Xin Huang, Chen Liang, Bao Hai, Lixiang Ding, Hongwei Zhu, Xianhai Wang, Feng Wei, Hongling Chu, Xiaoguang Liu

Abstract

Background: Lumbar spinal stenosis (LSS) is one of the most frequent indications for spine surgery. Open decompression and fusion surgery was the most common treatment and used to be regarded as the golden standard treatment for LSS. In recent years, percutaneous endoscopic decompression surgery was also used for LSS. However, the effectiveness and safety of percutaneous endoscopic decompression in the treatment of LSS have not been supported by high-level evidence. Our aim is to 1) compare the effectiveness of percutaneous endoscopic decompression surgery and open decompression and fusion for the treatment of LSS. 2) Investigate the prognosis risk factors for LSS. 3) Evaluate the influence of percutaneous endoscopic decompression for the stability of operative level, and degeneration of adjacent level.

Methods: It's a prospective, multicenter cohort study. The study is performed at 4 centers in Beijing. This study plans to enroll 600 LSS patients (300 patients in the percutaneous endoscopic decompression group, and 300 patients in the open decompression and fusion group). The demographic variables, healthcare variables, symptom related variables, clinical assessment (Visual analogue score (VAS), Oswestry disability index (ODI), Japanese Orthopaedic Association score (JOA)), and radiological assessment (dynamic X-ray, CT, MRI) will be collected at baseline visit. Patients will follow up at 3, 6, 12 months. The primary outcome is the difference of improvement of ODI between baseline and 12-month follow-up between the two groups. The secondary outcome is the score changes of preoperative and postoperative VAS, the recovery rate of JOA, MacNab criteria, patient satisfaction, degeneration grade of adjacent level, ROM of operative level and adjacent level, complication rate.

Discussion: In this study, we propose to conduct a prospective registry study to address the major controversies of LSS decompression under percutaneous spinal endoscopy, and investigate the clinical efficacy and safety of percutaneous endoscopic decompression and open decompression in the treatment of LSS.

Trial registration: This study has been registered on clinicaltrials.gov in January 15, 2020 ( NCT04254757 ). (SPIRIT 2a).

Keywords: Comparative effectiveness; Lumbar spinal stenosis; Open decompression and fusion; Percutaneous endoscopic decompression.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Flow chart of the study. VAS, Visual analogue score (VAS); ODI, Oswestry disability index; JOA, Japanese Orthopaedic Association score. X-ray including anterior-posterior position, lateral position, flexion and extension position lumbar X-ray

References

    1. Katz JN, Harris MB. Clinical practice. Lumbar spinal stenosis. N Engl J Med. 2008;358(8):818–825. doi: 10.1056/NEJMcp0708097.
    1. Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016;352:h6234. doi: 10.1136/bmj.h6234.
    1. Deyo RA, Mirza SK, Martin BI, et al. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2010;303(13):1259–1265. doi: 10.1001/jama.2010.338.
    1. Du Bois M, Szpalski M, Donceel P. A decade's experience in lumbar spine surgery in Belgium: sickness fund beneficiaries, 2000-2009. Eur Spine J. 2012;21(12):2693–2703. doi: 10.1007/s00586-012-2381-1.
    1. Kovacs FM, Urrútia G, Alarcón JD. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine (Phila Pa 1976) 2011;36(20):E1335–E1351. doi: 10.1097/BRS.0b013e31820c97b1.
    1. Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008;358(8):794–810. doi: 10.1056/NEJMoa0707136.
    1. Bae HW, Rajaee SS, Kanim LE. Nationwide trends in the surgical management of lumbar spinal stenosis. Spine (Phila Pa 1976) 2013;38(11):916–926. doi: 10.1097/BRS.0b013e3182833e7c.
    1. Yavin D, Casha S, Wiebe S, et al. Lumbar fusion for degenerative disease: a systematic review and Meta-analysis. Neurosurgery. 2017;80(5):701–715. doi: 10.1093/neuros/nyw162.
    1. Peul WC, Moojen WA. Fusion for Lumbar Spinal Stenosis--Safeguard or Superfluous Surgical Implant? N Engl J Med. 2016;374(15):1478–1479. doi: 10.1056/NEJMe1600955.
    1. Mayor S. Fusion adds little value to decompression for lumbar spinal stenosis, studies show. BMJ. 2016;353:i2132. doi: 10.1136/bmj.i2132.
    1. Försth P, Ólafsson G, Carlsson T, et al. A randomized, controlled trial of fusion surgery for lumbar spinal stenosis. N Engl J Med. 2016;374(15):1413–1423. doi: 10.1056/NEJMoa1513721.
    1. Lee CW, Yoon KJ, Jun JH. Percutaneous endoscopic Laminotomy with Flavectomy by Uniportal, unilateral approach for the Lumbar Canal or lateral recess stenosis. World Neurosurg. 2018;113:e129–ee37. doi: 10.1016/j.wneu.2018.01.195.
    1. Lee CH, Choi M, Ryu DS, et al. Efficacy and safety of full-endoscopic decompression via Interlaminar approach for central or lateral recess spinal stenosis of the lumbar spine: a Meta-analysis. Spine (Phila Pa 1976) 2018;43(24):1756–1764. doi: 10.1097/BRS.0000000000002708.
    1. Sun F, Liang Q, Yan M, et al. Unilateral laminectomy by endoscopy in central Lumbar Canal spinal stenosis: technical note and early outcomes. Spine (Phila Pa 1976) 2020;45(14):E871–Ee77. doi: 10.1097/BRS.0000000000003478.
    1. McGrath LB, White-Dzuro GA, Hofstetter CP. Comparison of clinical outcomes following minimally invasive or lumbar endoscopic unilateral laminotomy for bilateral decompression. J Neurosurg Spine. 2019;30(4):1–9. doi: 10.3171/2018.9.SPINE18689.
    1. Rodriguez CS. Pain measurement in the elderly: a review. Pain Manag Nurs. 2001;2(2):38–46. doi: 10.1053/jpmn.2001.23746.
    1. Liu H, Tao H, Luo Z. Validation of the simplified Chinese version of the Oswestry disability index. Spine (Phila Pa 1976) 2009;34(11):1211–1216. doi: 10.1097/BRS.0b013e31819e2b34.
    1. Yao M, Li ZJ, Zhu S, et al. Simplified Chinese version of the Japanese Orthopaedic association Back pain evaluation questionnaire: cross-cultural adaptation, reliability, and validity for patients with low Back pain. Spine (Phila Pa 1976) 2018;43(6):E357–Ee64. doi: 10.1097/BRS.0000000000002424.
    1. Schizas C, Theumann N, Burn A, et al. Qualitative grading of severity of lumbar spinal stenosis based on the morphology of the dural sac on magnetic resonance images. Spine (Phila Pa 1976) 2010;35(21):1919–1924. doi: 10.1097/BRS.0b013e3181d359bd.
    1. Splettstößer A, Khan MF, Zimmermann B, et al. Correlation of lumbar lateral recess stenosis in magnetic resonance imaging and clinical symptoms. World J Radiol. 2017;9(5):223–229. doi: 10.4329/wjr.v9.i5.223.
    1. Lee S, Lee JW, Yeom JS, et al. A practical MRI grading system for lumbar foraminal stenosis. AJR Am J Roentgenol. 2010;194(4):1095–1098. doi: 10.2214/AJR.09.2772.
    1. Pfirrmann CW, Metzdorf A, Zanetti M, et al. Magnetic resonance classification of lumbar intervertebral disc degeneration. Spine (Phila Pa 1976) 2001;26(17):1873–1878. doi: 10.1097/00007632-200109010-00011.
    1. Choi KC, Shim HK, Park CJ, et al. Usefulness of percutaneous endoscopic lumbar Foraminoplasty for lumbar disc herniation. World Neurosurg. 2017;106:484–492. doi: 10.1016/j.wneu.2017.07.035.
    1. Youn MS, Shin JK, Goh TS, et al. Endoscopic posterior decompression under local anesthesia for degenerative lumbar spinal stenosis. J Neurosurg Spine. 2018;29(6):661–666. doi: 10.3171/2018.5.SPINE171337.
    1. Leone A, Guglielmi G, Cassar-Pullicino VN, et al. Lumbar intervertebral instability: a review. Radiology. 2007;245(1):62–77. doi: 10.1148/radiol.2451051359.
    1. Solberg TK, Sørlie A, Sjaavik K, et al. Would loss to follow-up bias the outcome evaluation of patients operated for degenerative disorders of the lumbar spine? Acta Orthop. 2011;82(1):56–63. doi: 10.3109/17453674.2010.548024.
    1. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342(25):1887–1892. doi: 10.1056/NEJM200006223422507.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi