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Relationship Between Spinopelvic Parameters and Clinical Symptoms of Low-grade Lumbar Isthmic Spondylolisthesis

Primary Purpose

Isthmic Spondylolisthesis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PI-LL
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Isthmic Spondylolisthesis focused on measuring Isthmic Spondylolisthesis, Spinopelvic parameter, Clinical symptom, Pelvic incidence, Lumbar lordosis

Eligibility Criteria

54 Years - 76 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IS GROUP

AS GROUP

Arm Description

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

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

Outcomes

Primary Outcome Measures

PI
pelvic incidence
SS
sacral slope
PT
pelvic tilt
LL
lumbar lordosis
PI-LL
pelvic incidence minus lumbar lordosis

Secondary Outcome Measures

VAS
visual analogue scale
JOA
The Japanese Orthopaedic Association (JOA)

Full Information

First Posted
June 27, 2021
Last Updated
July 8, 2021
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04968626
Brief Title
Relationship Between Spinopelvic Parameters and Clinical Symptoms of Low-grade Lumbar Isthmic Spondylolisthesis
Official Title
Relationship Between Spinopelvic Parameters and Clinical Symptoms of Low-grade Lumbar Isthmic Spondylolisthesis: a Retrospective Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Isthmic spondylolisthesis (IS) is one of the most common types of spondylolisthesis, and spinopelvic parameters are closely related to the clinical symptoms of spinal diseases. In this study, investigators attempted to investigate the relationship between spinopelvic parameters and clinical symptoms of patients with low-grade (Meyerding grade I-II) isthmic spondylolisthesis (IS). A total of 120 patients with low-grade IS and 106 asymptomatic adults were included in this study. Sex, age and body mass index (BMI) were also collected. Various spinopelvic parameters were evaluated in whole-spine standing-position X-rays. The following spinopelvic parameters were measured: pelvic incidence (PI), sacral slope (SS), pelvic tilt (PT) and lumbar lordosis (LL). The clinical symptoms of the IS patients were assessed with the Japanese Orthopaedic Association (JOA) score and the visual analogue scale (VAS). Investigators compared spinopelvic parameters between the asymptomatic adults and the IS patients. Additionally, investigators investigated correlations between spinopelvic parameters and clinical symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Isthmic Spondylolisthesis
Keywords
Isthmic Spondylolisthesis, Spinopelvic parameter, Clinical symptom, Pelvic incidence, Lumbar lordosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IS GROUP
Arm Type
Experimental
Arm Description
Patients who received an operation to treat their isthmic spondylolisthesis (IS, Meyerding grade I-II)
Arm Title
AS GROUP
Arm Type
No Intervention
Arm Description
The asymptomatic adults had no history of severe back pain or spinal trauma
Intervention Type
Radiation
Intervention Name(s)
PI-LL
Other Intervention Name(s)
PI-LL mismatch
Intervention Description
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.
Primary Outcome Measure Information:
Title
PI
Description
pelvic incidence
Time Frame
through study completion, an average of 1 year
Title
SS
Description
sacral slope
Time Frame
through study completion, an average of 1 year
Title
PT
Description
pelvic tilt
Time Frame
through study completion, an average of 1 year
Title
LL
Description
lumbar lordosis
Time Frame
through study completion, an average of 1 year
Title
PI-LL
Description
pelvic incidence minus lumbar lordosis
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
VAS
Description
visual analogue scale
Time Frame
through study completion, an average of 1 year
Title
JOA
Description
The Japanese Orthopaedic Association (JOA)
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
54 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: isthmic spondylolisthesis subjects had spondylolisthesis at L4 or L5 (Meyerding grade I-II) with whole-spine standing lateral images Exclusion Criteria: spondylolisthesis of other types (Degenerative, dysplastic, etc.); Lumbar infection and/or tumor diseases; A previous history of lumbar fusion surgery.
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
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27811518
Citation
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Relationship Between Spinopelvic Parameters and Clinical Symptoms of Low-grade Lumbar Isthmic Spondylolisthesis

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