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Completed

NCT Number: NCT04968626

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

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.

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Key information

Age range

54 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PI-LL

Radiation

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.

Other names: PI-LL mismatch

Primary outcomes

  1. PI

    Time frame: through study completion, an average of 1 year

    pelvic incidence

  2. SS

    Time frame: through study completion, an average of 1 year

    sacral slope

  3. PT

    Time frame: through study completion, an average of 1 year

    pelvic tilt

  4. LL

    Time frame: through study completion, an average of 1 year

    lumbar lordosis

  5. PI-LL

    Time frame: through study completion, an average of 1 year

    pelvic incidence minus lumbar lordosis

Secondary outcomes

  1. VAS

    Time frame: through study completion, an average of 1 year

    visual analogue scale

  2. JOA

    Time frame: through study completion, an average of 1 year

    The Japanese Orthopaedic Association (JOA)

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Relationship Between Spinopelvic Parameters and Clinical Symptoms of Low-grade Lumbar Isthmic Spondylolisthesis: a Retrospective Analysis

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2021
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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