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

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06075355
• Other study ID #: Sagittal
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Fondation Hôpital Saint-Joseph
• Contact: Pierre Emmanuel Moreau, MD
• Phone: +33144127038
• Email: pemoreau[@]ghpsj.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Locations

Country	Name	City	State
France	Hôpital Paris Saint Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Hôpital Saint-Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of sagittal balance after minimally invasive decompression surgery	Sagittal Vertebral axis mesurement before and after surgery	3 months
Secondary	barrey Ratio	mesurement of the Barrey Ratio before and after surgery	3 months
Secondary	lumbar lordosis	mesurement of the lumbar lordosis before and after surgery	3 months
Secondary	pelvic incidence	mesurement of the pelvic incidence before and after surgery	3 months
Secondary	pelvic version	mesurement of the pelvic version before and after surgery	3 months
Secondary	sacred gradient	mesurement of the sacred version before and after surgery	3 months
Secondary	thoracic kyphosis	mesurement of the thoracic kyphosis before and after surgery	3 months