NCT05927662

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

3 years

First QC Date

June 8, 2023

Last Update Submit

June 28, 2023

Conditions

Displacement of Intervertebral Disc Without Myelopathy

Keywords

intervertebral disc displacement, spinal curvatures, Outcome

Outcome Measures

Primary Outcomes (2)

  • Oswestry Disability Index (ODI)

    quantify disability for low back pain

    change between preoperative and postoperative last (12th month) control

  • Japanese Orthopedic Association scores

    a simple scoring measure for radiculopathy with 29 points: Excellent neurological function 25-28 points: Good neurological function 17-24 points: Fair neurological function 11-16 points: Poor neurological function 10 points and below: Bad neurological function

    at 12th month control

Secondary Outcomes (8)

  • Body mass index (kg/cm2)

    preoperative

  • abdominal diameter

    preoperative

  • classification of disc degeneration

    change between preoperative and at 12th month control

  • visual analogue scale

    change between preoperative and postoperative 1st, 6th and 12th month controls

  • Tanita-SC 240 body analysis

    preoperative and 12th month control

  • +3 more secondary outcomes

Study Arms (2)

Type 2

Patients with Roussouly type 2 sagittal profile

Procedure: lumbar discectomy

Type 1,3,4

Patients with other Roussouly type sagittal profiles (1,3,4)

Procedure: lumbar discectomy

Interventions

lumbar discectomyPROCEDURE

mini-open discectomy

Type 1,3,4Type 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with lumbar disc herniation who are candidates for surgical treatment

You may qualify if:

  • 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

You may not qualify if:

  • Patients with spondyloarthropathy
  • Recurrent disc herniation
  • Spinal instability
  • \>10 degrees of coronal deformity
  • Incomplete data in the records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk Sanatoryum SUAM

Ankara, Turkey (Türkiye)

Location

Related Publications (27)

  • 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.

    PMID: 33290374RESULT

  • Ropper AH, Zafonte RD. Sciatica. N Engl J Med. 2015 Mar 26;372(13):1240-8. doi: 10.1056/NEJMra1410151. No abstract available.

    PMID: 25806916RESULT

  • 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.

    PMID: 23076645RESULT

  • 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.

    PMID: 23026867RESULT

  • 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.

    PMID: 35190388RESULT

  • 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.

    PMID: 16508552RESULT

  • 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.

    PMID: 30848331RESULT

  • 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.

    PMID: 3787326RESULT

  • 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.

    PMID: 18853159RESULT

  • 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.

    PMID: 10586454RESULT

  • 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.

    PMID: 15834338RESULT

  • 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.

    PMID: 25431963RESULT

  • 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.

    PMID: 21809016RESULT

  • 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.

    PMID: 20091188RESULT

  • 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.

    PMID: 27444272RESULT

  • 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.

    PMID: 15682018RESULT

  • 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.

    PMID: 11568697RESULT

  • 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.

    PMID: 18502912RESULT

  • 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.

    PMID: 15687851RESULT

  • 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.

    PMID: 28455623RESULT

  • 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.

    PMID: 30020277RESULT

  • 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.

    PMID: 36309336RESULT

  • 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.

    PMID: 29433530RESULT

  • 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.

    PMID: 28980275RESULT

  • 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.

    PMID: 23418543RESULT

  • 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.

    PMID: 16960163RESULT

  • 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.

    PMID: 16915105RESULT

MeSH Terms

Conditions

Intervertebral Disc DisplacementSpinal Curvatures

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • süheyla atay

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

June 8, 2023

First Posted

July 3, 2023

Study Start

February 1, 2019

Primary Completion

January 31, 2022

Study Completion

February 6, 2023

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)