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

NCT06075355 | Not Yet Recruiting

• 1 other identifier: Sagittal
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lumbar Spinal Stenosis

Keywords

lumbar stenosis; sagittal imbalance; minimally invasive decompression surgery

Outcome Measures

Primary Outcomes (1)

• Evolution of sagittal balance after minimally invasive decompression surgery

  Sagittal Vertebral axis mesurement before and after surgery

  3 months

Secondary Outcomes (6)

• barrey Ratio

  3 months

• lumbar lordosis

  3 months

• pelvic incidence

  3 months

• pelvic version

  3 months

• sacred gradient

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Hôpital Paris Saint Joseph

Paris, 75014, France

Location

MeSH Terms

Conditions

Spinal Stenosis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pierre Emmanuel Moreau, MD

CONTACT

+33144127038; pemoreau@ghpsj.fr

Hélène Beaussier, pharmaD, phD

CONTACT

+33144127038; crc@ghpsj.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: June 30, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

FR (1)