Results of Mini-open Discectomy According to Sagittal Profile
NCT ID: NCT05927662
Last Updated: 2023-07-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
50 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-02-01
Study Completion Date
2023-02-06
Brief Summary
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In the normal healthy population, the sagittal alignment can be divided into four types based on the size of the sacral slope and lumbar lordosis. The effect of this sagittal profile especially type 2 with almost straight lordosis on the clinical outcomes of patients after mini-open discectomy is unknown. In this study, the results of patients who underwent mini-open discectomy were evaluated according to sagittal profile types of the patients.
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Detailed Description
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Lumbar disc herniation (LDH) is the most common cause of sciatica and when conservative treatment fails or there is progressive neurological deficit, surgical excision of the herniated nucleosus pulposus is standard of care. Although minimally invasive methods such as endoscopic discectomy have been tried to be popular in recent years, open lumbar discectomy is still successfully performed in lumbar disc herniations due to some drawbacks of endoscopic techniques such as having long learning curve, higher radiation exposure to the surgeon, similar long-term results or the deception of commercial enterprises about endoscopic techniques and the pressure placed on surgeons in this direction.
Herniation of the nucleus pulposus as a result of massive LDH will inevitably result in disruption of normal lumbar biomechanics. Moreover, it has been shown that the healing process of the posterolateral herniation, which is biologically the weakest part of the posterior longitudinal ligament, will cause disc degeneration as a result of the repair and inflammation process in the annulus. However, the same authors claimed that, unlike the process in discogenic low back pain, macrophages in herniated discs can act to remove free pulposus fragments. There are few studies in the literature about the long-term consequences of this degeneration, which the investigators can consider as an accelerated aging process. Although clinically very successful results are obtained in the early postoperative period, it has been reported that the long-term success after discectomy may decrease from 90% to 60% over time. Depression or somatization, strenuous job and recurrent disc herniation or degeneration have been shown to cause long-term regression of results. In a prospective cohort study the authors reported a similar or worse leg pain rate in 30% of patients at the end of 10 years. In a study investigating reoperation after open lumbar discectomy, it was reported that the estimated rate of reoperation reached almost 45% at the end of 30 years.
In an extraordinary review evaluating the spinopelvic organization and the pathological adaptation to it, the mechanical stress, especially increased by hypolordosis, would cause the degenerative process in the spine to progress more rapidly. The basic theories explaining this are that the contact force, which is defined as the resultant force of the system created by gravity and abdominal pressure from the front and the dense paraspinal muscle mass from the posterior, mainly targets the discs. However, studies evaluating spinopelvic orientation in patients with LDH are limited. In a case-control study investigating the relationship between sciatica and spinopelvic harmony, more vertical sacrum, anterior C7 plumb line and hypolordosis were found in the LDH group. In a study examining the etiology and mechanism of sagittal imbalance caused by LDH, lumbar lordosis improved almost twice after endoscopic discectomy and LDH is probably one of the causes of compensatory sagittal imbalance.
Although there are studies on the pathogenesis and mechanics of LDH's etiology and post-discectomy results, the effect of the generally accepted normal lordosis types described by Roussouly P. on the degenerative process and patient scores after open standard discectomy is unknown. Therefore, in this study, the investigators aimed to compare the clinical results of patients with hypolordotic Type 2 and other types after open discectomy. Our hypothesis is that the mid-term clinical scores will be worse in Roussouly Type 2 patients with less lordosis.
Herniation of the nucleus pulposus as a result of massive LDH will inevitably result in disruption of normal lumbar biomechanics. Moreover, it has been shown that the healing process of the posterolateral herniation, which is biologically the weakest part of the posterior longitudinal ligament, will cause disc degeneration as a result of the repair and inflammation process in the annulus. However, the same authors claimed that, unlike the process in discogenic low back pain, macrophages in herniated discs can act to remove free pulposus fragments. There are few studies in the literature about the long-term consequences of this degeneration, which the investigators can consider as an accelerated aging process. Although clinically very successful results are obtained in the early postoperative period, it has been reported that the long-term success after discectomy may decrease from 90% to 60% over time. Depression or somatization, strenuous job and recurrent disc herniation or degeneration have been shown to cause long-term regression of results. In a prospective cohort study the authors reported a similar or worse leg pain rate in 30% of patients at the end of 10 years. In a study investigating reoperation after open lumbar discectomy, it was reported that the estimated rate of reoperation reached almost 45% at the end of 30 years.
In an extraordinary review evaluating the spinopelvic organization and the pathological adaptation to it, the mechanical stress, especially increased by hypolordosis, would cause the degenerative process in the spine to progress more rapidly. The basic theories explaining this are that the contact force, which is defined as the resultant force of the system created by gravity and abdominal pressure from the front and the dense paraspinal muscle mass from the posterior, mainly targets the discs. However, studies evaluating spinopelvic orientation in patients with LDH are limited. In a case-control study investigating the relationship between sciatica and spinopelvic harmony, more vertical sacrum, anterior C7 plumb line and hypolordosis were found in the LDH group. In a study examining the etiology and mechanism of sagittal imbalance caused by LDH, lumbar lordosis improved almost twice after endoscopic discectomy and LDH is probably one of the causes of compensatory sagittal imbalance.
Although there are studies on the pathogenesis and mechanics of LDH's etiology and post-discectomy results, the effect of the generally accepted normal lordosis types described by Roussouly P. on the degenerative process and patient scores after open standard discectomy is unknown. Therefore, in this study, the investigators aimed to compare the clinical results of patients with hypolordotic Type 2 and other types after open discectomy. Our hypothesis is that the mid-term clinical scores will be worse in Roussouly Type 2 patients with less lordosis.
Conditions
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Displacement of Intervertebral Disc Without Myelopathy
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Type 2
Patients with Roussouly type 2 sagittal profile
lumbar discectomy
Intervention Type
PROCEDURE
mini-open discectomy
Type 1,3,4
Patients with other Roussouly type sagittal profiles (1,3,4)
lumbar discectomy
Intervention Type
PROCEDURE
mini-open discectomy
Interventions
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lumbar discectomy
mini-open discectomy
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* Patients with complete skeletal maturation (\>18 years)
* Lumbar disc herniation with \>50% canal narrowing
* Severe leg and back pain associated with large LDH
* \>6 weeks of unsuccessful conservative treatment
* Signed a written consent form
* Lumbar disc herniation with \>50% canal narrowing
* Severe leg and back pain associated with large LDH
* \>6 weeks of unsuccessful conservative treatment
* Signed a written consent form
Exclusion Criteria
* Patients with spondyloarthropathy
* Recurrent disc herniation
* Spinal instability
* \>10 degrees of coronal deformity
* Incomplete data in the records
* Recurrent disc herniation
* Spinal instability
* \>10 degrees of coronal deformity
* Incomplete data in the records
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Saglik Bilimleri Universitesi
OTHER
Sponsor Role
lead
Responsible Party
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İsmail Demirkale
clinical professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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süheyla atay
Role: STUDY_CHAIR
Saglik Bilimleri Universitesi
Locations
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Atatürk Sanatoryum SUAM
Ankara, , Turkey (Türkiye)
Site Status
Countries
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Turkey (Türkiye)
References
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Gadjradj PS, Harhangi BS, Amelink J, van Susante J, Kamper S, van Tulder M, Peul WC, Vleggeert-Lankamp C, Rubinstein SM. Percutaneous Transforaminal Endoscopic Discectomy Versus Open Microdiscectomy for Lumbar Disc Herniation: A Systematic Review and Meta-analysis. Spine (Phila Pa 1976). 2021 Apr 15;46(8):538-549. doi: 10.1097/BRS.0000000000003843.
Reference Type
RESULT
Ropper AH, Zafonte RD. Sciatica. N Engl J Med. 2015 Mar 26;372(13):1240-8. doi: 10.1056/NEJMra1410151. No abstract available.
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RESULT
Hsu HT, Chang SJ, Yang SS, Chai CL. Learning curve of full-endoscopic lumbar discectomy. Eur Spine J. 2013 Apr;22(4):727-33. doi: 10.1007/s00586-012-2540-4. Epub 2012 Oct 17.
Reference Type
RESULT
Ahn Y, Kim CH, Lee JH, Lee SH, Kim JS. Radiation exposure to the surgeon during percutaneous endoscopic lumbar discectomy: a prospective study. Spine (Phila Pa 1976). 2013 Apr 1;38(7):617-25. doi: 10.1097/BRS.0b013e318275ca58.
Reference Type
RESULT
Gadjradj PS, Rubinstein SM, Peul WC, Depauw PR, Vleggeert-Lankamp CL, Seiger A, van Susante JL, de Boer MR, van Tulder MW, Harhangi BS. Full endoscopic versus open discectomy for sciatica: randomised controlled non-inferiority trial. BMJ. 2022 Feb 21;376:e065846. doi: 10.1136/bmj-2021-065846.
Reference Type
RESULT
Peng B, Hao J, Hou S, Wu W, Jiang D, Fu X, Yang Y. Possible pathogenesis of painful intervertebral disc degeneration. Spine (Phila Pa 1976). 2006 Mar 1;31(5):560-6. doi: 10.1097/01.brs.0000201324.45537.46.
Reference Type
RESULT
Benzakour A, Benzakour T. Lumbar disc herniation: long-term outcomes after mini-open discectomy. Int Orthop. 2019 Apr;43(4):869-874. doi: 10.1007/s00264-019-04312-2. Epub 2019 Mar 8.
Reference Type
RESULT
Prolo DJ, Oklund SA, Butcher M. Toward uniformity in evaluating results of lumbar spine operations. A paradigm applied to posterior lumbar interbody fusions. Spine (Phila Pa 1976). 1986 Jul-Aug;11(6):601-6. doi: 10.1097/00007632-198607000-00012.
Reference Type
RESULT
Guo JJ, Yang H, Tang T. Long-term outcomes of the revision open lumbar discectomy by fenestration: A follow-up study of more than 10 years. Int Orthop. 2009 Oct;33(5):1341-5. doi: 10.1007/s00264-008-0648-2. Epub 2008 Oct 14.
Reference Type
RESULT
Loupasis GA, Stamos K, Katonis PG, Sapkas G, Korres DS, Hartofilakidis G. Seven- to 20-year outcome of lumbar discectomy. Spine (Phila Pa 1976). 1999 Nov 15;24(22):2313-7. doi: 10.1097/00007632-199911150-00005.
Reference Type
RESULT
Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). 2005 Apr 15;30(8):927-35. doi: 10.1097/01.brs.0000158954.68522.2a.
Reference Type
RESULT
Son IN, Kim YH, Ha KY. Long-term clinical outcomes and radiological findings and their correlation with each other after standard open discectomy for lumbar disc herniation. J Neurosurg Spine. 2015 Feb;22(2):179-84. doi: 10.3171/2014.10.SPINE131126. Epub 2014 Nov 28.
Reference Type
RESULT
Roussouly P, Pinheiro-Franco JL. Biomechanical analysis of the spino-pelvic organization and adaptation in pathology. Eur Spine J. 2011 Sep;20 Suppl 5(Suppl 5):609-18. doi: 10.1007/s00586-011-1928-x. Epub 2011 Aug 2.
Reference Type
RESULT
Endo K, Suzuki H, Tanaka H, Kang Y, Yamamoto K. Sagittal spinal alignment in patients with lumbar disc herniation. Eur Spine J. 2010 Mar;19(3):435-8. doi: 10.1007/s00586-009-1240-1. Epub 2009 Dec 20.
Reference Type
RESULT
Liang C, Sun J, Cui X, Jiang Z, Zhang W, Li T. Spinal sagittal imbalance in patients with lumbar disc herniation: its spinopelvic characteristics, strength changes of the spinal musculature and natural history after lumbar discectomy. BMC Musculoskelet Disord. 2016 Jul 22;17:305. doi: 10.1186/s12891-016-1164-y.
Reference Type
RESULT
Roussouly P, Gollogly S, Berthonnaud E, Dimnet J. Classification of the normal variation in the sagittal alignment of the human lumbar spine and pelvis in the standing position. Spine (Phila Pa 1976). 2005 Feb 1;30(3):346-53. doi: 10.1097/01.brs.0000152379.54463.65.
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RESULT
Pfirrmann CW, Metzdorf A, Zanetti M, Hodler J, Boos N. Magnetic resonance classification of lumbar intervertebral disc degeneration. Spine (Phila Pa 1976). 2001 Sep 1;26(17):1873-8. doi: 10.1097/00007632-200109010-00011.
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RESULT
van den Hout WB, Peul WC, Koes BW, Brand R, Kievit J, Thomeer RT; Leiden-The Hague Spine Intervention Prognostic Study Group. Prolonged conservative care versus early surgery in patients with sciatica from lumbar disc herniation: cost utility analysis alongside a randomised controlled trial. BMJ. 2008 Jun 14;336(7657):1351-4. doi: 10.1136/bmj.39583.709074.BE. Epub 2008 May 23.
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RESULT
Berthonnaud E, Dimnet J, Roussouly P, Labelle H. Analysis of the sagittal balance of the spine and pelvis using shape and orientation parameters. J Spinal Disord Tech. 2005 Feb;18(1):40-7. doi: 10.1097/01.bsd.0000117542.88865.77.
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RESULT
Laouissat F, Sebaaly A, Gehrchen M, Roussouly P. Classification of normal sagittal spine alignment: refounding the Roussouly classification. Eur Spine J. 2018 Aug;27(8):2002-2011. doi: 10.1007/s00586-017-5111-x. Epub 2017 Apr 28.
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RESULT
Pizones J, Martin MB, Perez-Grueso FJS, Yilgor C, Vila-Casademunt A, Serra-Burriel M, Obeid I, Alanay A, Acaroglu ER, Pellise F; ESSG European Spine Study Group. Impact of Adult Scoliosis on Roussouly Sagittal Shape Classification. Spine (Phila Pa 1976). 2019 Feb 15;44(4):270-279. doi: 10.1097/BRS.0000000000002800.
Reference Type
RESULT
Wu J, Chen Z, Wang H, Tian Y, Ma X, Lyu F, Jiang J, Wang H. The Influence of Roussouly Type on the Prevalence, Subtype, and Distribution Characteristics of Modic Changes in Patients with Lumbar Degenerative Disc Disease. World Neurosurg. 2023 Jan;169:e102-e109. doi: 10.1016/j.wneu.2022.10.070. Epub 2022 Oct 26.
Reference Type
RESULT
Zhang F, Zhang K, Tian HJ, Wu AM, Cheng XF, Zhou TJ, Zhao J. Correlation between lumbar intervertebral disc height and lumbar spine sagittal alignment among asymptomatic Asian young adults. J Orthop Surg Res. 2018 Feb 12;13(1):34. doi: 10.1186/s13018-018-0737-x.
Reference Type
RESULT
Amin RM, Andrade NS, Neuman BJ. Lumbar Disc Herniation. Curr Rev Musculoskelet Med. 2017 Dec;10(4):507-516. doi: 10.1007/s12178-017-9441-4.
Reference Type
RESULT
Takatalo J, Karppinen J, Taimela S, Niinimaki J, Laitinen J, Sequeiros RB, Samartzis D, Korpelainen R, Nayha S, Remes J, Tervonen O. Association of abdominal obesity with lumbar disc degeneration--a magnetic resonance imaging study. PLoS One. 2013;8(2):e56244. doi: 10.1371/journal.pone.0056244. Epub 2013 Feb 13.
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RESULT
Warnberg J, Nova E, Moreno LA, Romeo J, Mesana MI, Ruiz JR, Ortega FB, Sjostrom M, Bueno M, Marcos A; AVENA Study Group. Inflammatory proteins are related to total and abdominal adiposity in a healthy adolescent population: the AVENA Study. Am J Clin Nutr. 2006 Sep;84(3):505-12. doi: 10.1093/ajcn/84.3.505.
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RESULT
Adams MA, Roughley PJ. What is intervertebral disc degeneration, and what causes it? Spine (Phila Pa 1976). 2006 Aug 15;31(18):2151-61. doi: 10.1097/01.brs.0000231761.73859.2c.
Reference Type
RESULT
Other Identifiers
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2012KAEK15-2603
Identifier Type: -
Identifier Source: org_study_id
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