Clinical trial NCT04968626: 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
Overall status: COMPLETED
Phase: NA
Conditions: Isthmic Spondylolisthesis
Keywords: Isthmic Spondylolisthesis
Spinopelvic parameter
Clinical symptom
Pelvic incidence
Lumbar lordosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 226
Sex: ALL
Minimum age (years): 54
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PI
timeFrame: through study completion, an average of 1 year
measure: SS
timeFrame: through study completion, an average of 1 year
measure: PT
timeFrame: through study completion, an average of 1 year
measure: LL
timeFrame: through study completion, an average of 1 year
measure: PI-LL
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: VAS
timeFrame: through study completion, an average of 1 year
measure: JOA
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
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