NCT04968626

Brief Summary

This was a retrospective study.PI and LL greatly influence IS and its progression. However, relationships between the spinopelvic parameters and clinical symptoms of patients with IS were not fully investigated in previous studies. Investigators hypothesized that spinopelvic parameters might be related to the clinical symptoms of IS patients. Therefore, the purpose of the present study was to investigate whether differences in spinopelvic parameters, especially spinopelvic alignment, may be associated with the clinical symptoms of low-grade IS patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

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

March 19, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
Last Updated

July 20, 2021

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

June 27, 2021

Last Update Submit

July 8, 2021

Conditions

Isthmic Spondylolisthesis

Keywords

Isthmic SpondylolisthesisSpinopelvic parameterClinical symptomPelvic incidenceLumbar lordosis

Outcome Measures

Primary Outcomes (5)

  • PI

    pelvic incidence

    through study completion, an average of 1 year

  • SS

    sacral slope

    through study completion, an average of 1 year

  • PT

    pelvic tilt

    through study completion, an average of 1 year

  • LL

    lumbar lordosis

    through study completion, an average of 1 year

  • PI-LL

    pelvic incidence minus lumbar lordosis

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • VAS

    through study completion, an average of 1 year

  • JOA

    through study completion, an average of 1 year

Study Arms (2)

IS GROUP

EXPERIMENTAL

Patients who received an operation to treat their isthmic spondylolisthesis (IS, Meyerding grade I-II)

Radiation: PI-LL

AS GROUP

NO INTERVENTION

The asymptomatic adults had no history of severe back pain or spinal trauma

Interventions

PI-LLRADIATION

The pelvic parameters were collected including PI, pelvic tilt (PT), sacral slope (SS) and LL ,and compared between IS patients and the AS group. Besides, spinopelvic malalignment was defined as an absolute value of PI-LL greater than 10.In the IS group,the clinical symptoms were assessed with the Japanese Orthopaedic Association (JOA) score and the visual analogue scale (VAS). We compared spinopelvic parameters between the asymptomatic adults and the IS patients. Additionally, we investigated correlations between spinopelvic parameters and clinical symptoms.

Also known as: PI-LL mismatch
IS GROUP

Eligibility Criteria

Age54 Years - 76 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • isthmic spondylolisthesis subjects had spondylolisthesis at L4 or L5 (Meyerding grade I-II) with whole-spine standing lateral images

You may not qualify if:

  • spondylolisthesis of other types (Degenerative, dysplastic, etc.);
  • Lumbar infection and/or tumor diseases;
  • A previous history of lumbar fusion surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (10)

  • Randall RM, Silverstein M, Goodwin R. Review of Pediatric Spondylolysis and Spondylolisthesis. Sports Med Arthrosc Rev. 2016 Dec;24(4):184-187. doi: 10.1097/JSA.0000000000000127.

    PMID: 27811518RESULT

  • Urrutia J, Cuellar J, Zamora T. Spondylolysis and spina bifida occulta in pediatric patients: prevalence study using computed tomography as a screening method. Eur Spine J. 2016 Feb;25(2):590-5. doi: 10.1007/s00586-014-3480-y. Epub 2014 Jul 29.

    PMID: 25070790RESULT

  • Ramadorai U, Hire J, DeVine JG, Brodt ED, Dettori JR. Incidental findings on magnetic resonance imaging of the spine in the asymptomatic pediatric population: a systematic review. Evid Based Spine Care J. 2014 Oct;5(2):95-100. doi: 10.1055/s-0034-1386753.

    PMID: 25278883RESULT

  • Beutler WJ, Fredrickson BE, Murtland A, Sweeney CA, Grant WD, Baker D. The natural history of spondylolysis and spondylolisthesis: 45-year follow-up evaluation. Spine (Phila Pa 1976). 2003 May 15;28(10):1027-35; discussion 1035. doi: 10.1097/01.BRS.0000061992.98108.A0.

    PMID: 12768144RESULT

  • Duval-Beaupere G, Schmidt C, Cosson P. A Barycentremetric study of the sagittal shape of spine and pelvis: the conditions required for an economic standing position. Ann Biomed Eng. 1992;20(4):451-62. doi: 10.1007/BF02368136.

    PMID: 1510296RESULT

  • Maciejczak A, Jablonska K, Baczek D, Barnas P, Czternastek M, Dudziak P, Georgiew F, Jagiello-Bajer B, Litwora B, Maslanka P, Konior R, Orzech J. Changes in spino-pelvic alignment after surgical treatment of isthmic spondylolisthesis. Neurol Neurochir Pol. 2014 Jan-Feb;48(1):21-9. doi: 10.1016/j.pjnns.2013.05.001. Epub 2014 Jan 23.

    PMID: 24636766RESULT

  • Park SJ, Lee CS, Chung SS, Kang KC, Shin SK. Postoperative changes in pelvic parameters and sagittal balance in adult isthmic spondylolisthesis. Neurosurgery. 2011 Jun;68(2 Suppl Operative):355-63; discussion 362-3. doi: 10.1227/NEU.0b013e3182117249.

    PMID: 21336205RESULT

  • Lafage R, Liabaud B, Diebo BG, Oren JH, Vira S, Pesenti S, Protopsaltis TS, Errico TJ, Schwab FJ, Lafage V. Defining the Role of the Lower Limbs in Compensating for Sagittal Malalignment. Spine (Phila Pa 1976). 2017 Nov 15;42(22):E1282-E1288. doi: 10.1097/BRS.0000000000002157.

    PMID: 28306639RESULT

  • Minamide A, Yoshida M, Iwahashi H, Simpson AK, Yamada H, Hashizume H, Nakagawa Y, Iwasaki H, Tsutsui S, Kagotani R, Sonekatsu M, Sasaki T, Shinto K, Deguchi T. Minimally invasive decompression surgery for lumbar spinal stenosis with degenerative scoliosis: Predictive factors of radiographic and clinical outcomes. J Orthop Sci. 2017 May;22(3):377-383. doi: 10.1016/j.jos.2016.12.022. Epub 2017 Feb 1.

    PMID: 28161236RESULT

  • Shi L, Chen Y, Miao J, Shi J, Chen D. Reduction of Slippage Influences Surgical Outcomes of Grade II and III Lumbar Isthmic Spondylolisthesis. World Neurosurg. 2018 Dec;120:e1017-e1023. doi: 10.1016/j.wneu.2018.08.217. Epub 2018 Sep 7.

    PMID: 30201580RESULT

MeSH Terms

Conditions

Lordosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 20, 2021

Study Start

March 19, 2019

Primary Completion

January 1, 2021

Study Completion

May 1, 2021

Last Updated

July 20, 2021

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN(1)