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

NCT ID: NCT06075355

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 116 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-03-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Paris Saint Joseph

Paris, , France

Countries

France

Central Contacts

Pierre Emmanuel Moreau, MD

Role: CONTACT

pemoreau@ghpsj.fr

+33144127038

Hélène Beaussier, pharmaD, phD

Role: CONTACT

crc@ghpsj.fr

+33144127038

Facility Contacts

Hélène BEAUSSIER, pharmaD, PhD

Role: primary

hbeaussier@ghpsj.fr

+33144127038

Juliette COURTIADE MAHLER, phD

Role: backup

jcourtiade@ghpsj.fr

+33144127963

Other Identifiers

Sagittal

Identifier Type: -

Identifier Source: org_study_id