Can Minimally Invasive Decompression Surgery Restore Sagittal Balance in a Patient Population With Sagittal Imbalance and Lumbar Spinal Stenosis

Sagittal : Can Minimally Invasive Decompression Surgery Restore Sagittal Balance in a Patient Population With Sagittal Imbalance and Lumbar Spinal Stenosis

From adulthood onwards, the aging process manifests itself in the spine through loss of disc height and kyphotic deformity. As the general population ages, the prevalence of lumbar degenerative diseases and sagittal imbalance increases. Sagittal balance is a physiological alignment resulting from the effective muscular and ligamentary forces that place patients' heads harmoniously in line with their pelvis. Roussouly first classified this alignment by differentiating four types of balance in an asymptomatic population. He established a link between the varieties of sagittal balance of the spine, the sacral slope and the position of the pelvis in space. He went on to explain sagittal imbalance in the aging population suffering from degenerative diseases.

One of the most common lumbar degenerative diseases is lumbar spinal canal stenosis. Stenosis of the lumbar spinal canal is frequently associated with sagittal imbalance of the spine. Lumbar canal stenosis causes lumbar pain, leg pain, neurogenic intermittent claudication and bladder and rectal disorders. The severity of clinical symptoms increases linearly with progressive sagittal imbalance [8]. We represent the sagittal imbalance of the spine by a positive sagittal vertical axis (SVA) presented by patients to reduce the pressure exerted by the yellow ligament, which is hypertrophied in degenerative disease . Many have shown that this forward-flexing posture can be improved by simple decompression, and that this deformity corresponds to an analgesic position and not to a structural deformity. Little is known about the factors that influence alignment after lumbar canal decompression and short segment fusion.

This study therefore aims to elucidate some of the clinical and radiological factors likely to affect postoperative sagittal balance in patients undergoing simple minimally invasive decompression surgery and short segment fusion (1 or 2 levels).

Study Overview

• Status: Not yet recruiting
• Conditions: Lumbar Spinal Stenosis

• Study Type: Observational
• Enrollment (Estimated): 116

Contacts and Locations

• Study Contact: Name: Pierre Emmanuel Moreau, MD; Phone Number: +33144127038; Email: pemoreau@ghpsj.fr
• Study Contact Backup: Name: Hélène Beaussier, pharmaD, phD; Phone Number: +33144127038; Email: crc@ghpsj.fr

Study Locations

• France
  • Paris, France, 75014
    • Hopital Paris Saint Joseph
    • Contact: Hélène BEAUSSIER, pharmaD, PhD; Phone Number: +33144127038; Email: hbeaussier@ghpsj.fr
    • Contact: Juliette COURTIADE MAHLER, phD; Phone Number: +33144127963; Email: jcourtiade@ghpsj.fr
    • Principal Investigator: Pierre Emmanuel MOREAU, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

patient suffering from lumbar stenosis, adressed for minimally invasive lumbar decompression between january, 1st 2014 and january 31st, 2020

Description

Inclusion Criteria:

• Patient age ≥ 18 years
• French-speaking patients
• Patients undergoing minimally invasive lumbar decompression with or without one- or two-level arthrodesis
• Patients with preoperative sagittal imbalance measured on EOS images (sagittal vertebral axis > 50 mm)

Exclusion Criteria:

• Patients under guardianship or curatorship
• Patient deprived of liberty
• Patient under court protection
• Patient objecting to the use of his or her data for this study
• Revision surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of sagittal balance after minimally invasive decompression surgery	Sagittal Vertebral axis mesurement before and after surgery	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
barrey Ratio	mesurement of the Barrey Ratio before and after surgery	3 months
lumbar lordosis	mesurement of the lumbar lordosis before and after surgery	3 months
pelvic incidence	mesurement of the pelvic incidence before and after surgery	3 months
pelvic version	mesurement of the pelvic version before and after surgery	3 months
sacred gradient	mesurement of the sacred version before and after surgery	3 months
thoracic kyphosis	mesurement of the thoracic kyphosis before and after surgery	3 months

Collaborators and Investigators

• Sponsor: Fondation Hôpital Saint-Joseph

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: lumbar stenosis; sagittal imbalance; minimally invasive decompression surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: Sagittal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No