Dynamics of the sagittal profile of the spine after isolated decompression of intracanal neurovascular formations in degenerative lumbar stenosis: protocol of a prospective multicenter study**
https://doi.org/10.14531/ss2025.4.49-55
Abstract
Objective. To determine the impact of isolated decompression of intracanal neurovascular structures of the spine on sagittal balance in patients with degenerative lumbar stenosis. Study registration number: NCT07139938, clinicaltrials.gov.
Material and Methods. Adult patients with neurological and/or pain syndromes caused by degenerative lumbar stenosis confirmed by MRI will be enrolled in research centers across Russia. All patients will undergo isolated decompression of neurovascular structures without the use of any implants. The dynamics of sagittal balance parameters will be assessed at 3 and 12 months after surgery by comparing with preoperative data. The sample size was calculated in accordance with the hypothesis of non-inferiority. The study aims to enroll 165 patients. Patient recruitment will take 12 months, and the total duration of the study will be approximately 2 years.
Anticipated results. This study will provide valuable information on the potential for spontaneous correction of sagittal spinal parameters following isolated decompression without the use of implants.
** Dear colleagues! We invite you to participate in a multicenter prospective study of spontaneous correction of spinal sagittal balance in patients with degenerative spinal pathology after isolated decompression. The person responsible for inclusion in the multicenter study is Alexandr Vladimirovich Krutko, MD, PhD (National Medical Research Center of Traumatology and Orthopedics n.a. N.N. Priorov, Moscow), e-mail: KrutkoAV@cito-priorov.ru.
About the Authors
A. V. KrutkoRussian Federation
Aleksandr Vladimirovich Krutko, DMSc, head of Department of spine surgery,
9 Novospassky lane, Moscow, 115172, Russia
V. R. Zakharin
Russian Federation
Vitaly Romanovich Zakharin, MD, PhD, orthopedic surgeon,
9 Novospassky lane, Moscow, 115172, Russia
E. S. Baykov
Russian Federation
Evgenii Sergeyevich Baykov, MD, PhD, neurosurgeon, Department of spine surgery,
9 Novospassky lane, Moscow, 115172, Russia
A. I. Kokorev
Russian Federation
Alexey Ivanovich Kokorev, MD, PhD, orthopedic surgeon,
9 Novospassky lane, Moscow, 115172, Russia
G. E. Balychev
Russian Federation
Gleb Evgenyevich Balychev, orthopedic surgeon,
9 Novospassky lane, Moscow, 115172, Russia
O. N. Leonova
Russian Federation
Olga Nikolayevna Leonova, MD, PhD, scientific secretary,
9 Novospassky lane, Moscow, 115172, Russia
References
1. Shin EK, Kim CH, Chung CK, Choi Y, Yim D, Jung W, Park SB, Moon JH, Heo W, Kim SM. Sagittal imbalance in patients with lumbar spinal stenosis and outcomes after simple decompression surgery. Spine J. 2017;17:175–182. DOI: 10.1016/j.spinee.2016.08.023
2. Silva PS, Leocádio JSN, Vaz R, Pereira P. Influence of decompression surgery on sagittal balance parameters in patients with lumbar spinal stenosis. Sci Rep. 2025;15:11113. DOI: 10.1038/s41598-025-93319-4
3. Kögl N, Petr O, Löscher W, Liljenqvist U, Thomé C. Lumbar disc herniation – the significance of symptom duration for the indication for surgery. Dtsch Arztebl Int. 2024;121:440–448. DOI: 10.3238/arztebl.m2024.0074
4. Luan H, Wang Y, Liu K, Sheng W, Deng Q. Efficacy of transforaminal lumbar interbody fusion in the treatment of double-level lumbar spondylolisthesis with sagittal imbalance. BMC Musculoskelet Disord. 2022;23:1038. DOI: 10.1186/s12891-022-06018-w
5. Kwon JW, Moon SH, Park SY, Park SJ, Park SR, Suk KS, Kim HS, Lee BH. Lumbar spinal stenosis: review update 2022. Asian Spine J. 2022;16:789–798. DOI: 10.31616/asj.2022.0366
6. Katz JN, Zimmerman ZE, Mass H, Makhni MC. Diagnosis and management of lumbar spinal stenosis: a review. JAMA. 2022;327:1688–1699. DOI: 10.1001/jama.2022.5921
7. Ogura Y, Kobayashi Y, Shinozaki Y, Ogawa J. Spontaneous correction of sagittal spinopelvic malalignment after decompression surgery without corrective fusion procedure for lumbar spinal stenosis and its impact on clinical outcomes: A systematic review. J Orthop Sci. 2020;25:379–383. DOI: 10.1016/j.jos.2019.05.021
8. Buckland AJ, Vira S, Oren JH, Lafage R, Harris BY, Spiegel MA, Diebo BG, Liabaud B, Protopsaltis TS, Schwab FJ, Lafage V, Errico TJ, Bendo JA. When is compensation for lumbar spinal stenosis a clinical sagittal plane deformity? Spine J. 2016;16:971–981. DOI: 10.1016/j.spinee.2016.03.047
9. Suzuki H, Endo K, Kobayashi H, Tanaka H, Yamamoto K. Total sagittal spinal alignment in patients with lumbar canal stenosis accompanied by intermittent claudication. Spine (Phila Pa 1976). 2010;35:E344–E346. DOI: 10.1097/BRS.0b013e3181c91121
10. Ogura Y, Shinozaki Y, Kobayashi Y, Kitagawa T, Yonezawa Y, Takahashi Y, Yoshida K, Yasuda A, Ogawa J. Impact of decompression surgery without fusion for lumbar spinal stenosis on sagittal spinopelvic alignment: minimum 2-year follow-up. J Neurosurg Spine. 2019;30:743–749. DOI: 10.3171/2018.11.SPINE181092
11. Suzuki A, Nakamura H. Microendoscopic lumbar posterior decompression surgery for lumbar spinal stenosis: literature review. Medicina (Kaunas). 2022;58:384. DOI: 10.3390/medicina58030384
12. Schizas C, Theumann N, Burn A, Tansey R, Wardlaw D, Smith FW, Kulik G. 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;35:1919–1924. DOI: 10.1097/BRS.0b013e3181d359bd
13. Tan LX, Du XK, Tang RM, Rong LM, Zhang LM. Effect of spinal-pelvic sagittal balance on the clinical outcomes after lumbar fusion surgery. BMC Surg. 2023;23:334. DOI: 10.1186/s12893-023-02240-y
14. Schwab FJ, Blondel B, Bess S, Hostin R, Shaffrey CI, Smith JS, et al. Radiographical spinopelvic parameters and disability in the setting of adult spinal deformity: A prospective multicenter analysis. Spine (Phila Pa 1976). 2013;38:E803–E812. DOI: 10.1097/BRS.0b013e318292b7b9
15. Glassman SD, Bridwell K, Dimar JR, Horton W, Berven S, Schwab F. The impact of positive sagittal balance in adult spinal deformity. Spine (Phila Pa 1976). 2005;30:2024–2029. DOI: 10.1097/01.brs.0000179086.30449.96
16. Hikata T, Watanabe K, Fujita N, Iwanami A, Hosogane N, Ishii K, Nakamura M, Toyama Y, Matsumoto M. Impact of sagittal spinopelvic alignment on clinical outcomes after decompression surgery for lumbar spinal canal stenosis without coronal imbalance. J Neurosurg Spine. 2015;23:451–458. DOI: 10.3171/2015.1.SPINE14642
17. Dohzono S, Toyoda H, Takahashi S, Matsumoto T, Suzuki A, Terai H, Nakamura H. Factors associated with improvement in sagittal spinal alignment after microendoscopic laminotomy in patients with lumbar spinal canal stenosis. J Neurosurg Spine. 2016;25:39–45. DOI: 10.3171/2015.12.SPINE15805
18. Fujii K, Kawamura N, Ikegami M, Niitsuma G, Kunogi J. Radiological improvements in global sagittal alignment after lumbar decompression without fusion. Spine (Phila Pa 1976). 2015;40:703–709. DOI: 10.1097/BRS.0000000000000708
19. Wylde V, Dennis J, Beswick AD, Bruce J, Eccleston C, Howells N, Peters TJ, Gooberman-Hill R. Systematic review of management of chronic pain after surgery. Br J Surg. 2017;104:1293–1306. DOI: 10.1002/bjs.10601
20. Slätis P, Malmivaara A, Heliövaara M, Sainio P, Herno A, Kankare J, Seitsalo S, Tallroth K, Turunen V, Knekt P, Hurri H. Long-term results of surgery for lumbar spinal stenosis: a randomised controlled trial. Eur Spine J. 2011;20:1174–1181. DOI: 10.1007/s00586-010-1652-y
21. Lurie JD, Tosteson TD, Tosteson A, Abdu WA, Zhao W, Morgan TS, Weinstein JN. Long-term outcomes of lumbar spinal stenosis: Eight-year results of the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2015;40:63–76. DOI: 10.1097/BRS.0000000000000731
22. Wang X, Ji X. Sample size estimation in clinical research: from randomized controlled trials to observational studies. Chest. 2020;158(1S):S12–S20. DOI: 10.1016/j.chest.2020.03.010
23. Черепанов Е.А. Русская версия опросника Освестри: культурная адаптация и валидность. Хирургия позвоночника. 2009;(3):93–98. [Cherepanov E.A. Russian version of the Oswestry Disability Index: cross-cultural adaptation and validity. Russian Journal of Spine Surgery (Khirurgiya Pozvonochnika). 2009;(3):93–98.] DOI: 10.14531/ss2009.3.93-98 EDN: KXDEMR
24. Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986;27:117–126. DOI: 10.1016/0304-3959(86)90228-9
25. Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lantéri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005;114:29–36. DOI: 10.1016/j.pain.2004.12.010
26. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113:9–19. DOI: 10.1016/j.pain.2004.09.012
27. Grassi M, Nucera A, Zanolin E, Omenaas E, Anto JM, Leynaert B. Performance comparison of Likert and binary formats of SF-36 version 1.6 across ECRHS II adults populations. Value Health. 2007;10:478–488. DOI: 10.1111/j.1524-4733.2007.00203.x
28. Silva MG, Pilling BM, Candotti CT. Body posture self-assessment tools: a scoping review. Fisioter Pesqui. 2023;30(2). DOI: 10.1590/1809-2950/e22017823en
29. Rodby-Bousquet E, Ágústsson A, Jónsdóttir G, Czuba T, Johansson AC, Hägglund G. Interrater reliability and construct validity of the Posture and Postural Ability Scale in adults with cerebral palsy in supine, prone, sitting and standing positions. Clin Rehabil. 2014;28:82–90. DOI: 10.1177/0269215512465423
30. Guyatt GH, Norman GR, Juniper EF, Griffith LE. A critical look at transition ratings. J Clin Epidemiol. 2002;55:900–908. DOI: 10.1016/s0895-4356(02)00435-3
31. Park HY, Jung HY, Kim GU, Lee SH, Lee JS. Sagittal realignment following decompression for lumbar spinal stenosis in elderly patients: a comprehensive EOS imaging analysis. Diagnostics (Basel). 2024;14:2380. DOI: 10.3390/diagnostics14212380
32. Diebo BG, Balmaceno-Criss M, Lafage R, McDonald CL, Alsoof D, Halayqeh S, DiSilvestro KJ, Kuris EO, Lafage V, Daniels AH. Sagittal alignment in the degenerative lumbar spine: surgical plannng. J Bone Joint Surg Am. 2024;106:445–457. DOI: 10.2106/JBJS.23.00672
Review
For citations:
Krutko A.V., Zakharin V.R., Baykov E.S., Kokorev A.I., Balychev G.E., Leonova O.N. Dynamics of the sagittal profile of the spine after isolated decompression of intracanal neurovascular formations in degenerative lumbar stenosis: protocol of a prospective multicenter study**. Russian Journal of Spine Surgery (Khirurgiya Pozvonochnika). 2025;22(4):49-55. (In Russ.) https://doi.org/10.14531/ss2025.4.49-55






























