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

Isthmic Spondylolisthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04968626
• Other study ID #: M2019125
• Status: Completed
• Phase: N/A
• Start date: March 19, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: March 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: May 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 54 Years to 76 Years

Eligibility

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.

Related Conditions & MeSH terms

• Isthmic Spondylolisthesis
• Spondylolisthesis

Intervention

Radiation:
• PI-LL
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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View Citation

Duval-Beaupère 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. — View Citation

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 — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

Randall RM, Silverstein M, Goodwin R. Review of Pediatric Spondylolysis and Spondylolisthesis. Sports Med Arthrosc Rev. 2016 Dec;24(4):184-187. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PI	pelvic incidence	through study completion, an average of 1 year
Primary	SS	sacral slope	through study completion, an average of 1 year
Primary	PT	pelvic tilt	through study completion, an average of 1 year
Primary	LL	lumbar lordosis	through study completion, an average of 1 year
Primary	PI-LL	pelvic incidence minus lumbar lordosis	through study completion, an average of 1 year
Secondary	VAS	visual analogue scale	through study completion, an average of 1 year
Secondary	JOA	The Japanese Orthopaedic Association (JOA)	through study completion, an average of 1 year