NCT06335511

Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Azienda Usl di Bologna · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis.

Detailed description

Degenerative lumbar spine is the most common cause of chronic pain and disability with remarkable economic impact. Treatment begins with conservative options (physical combined with antalgic therapy) but often requires surgical treatment. Two different groups of patients affected by symptomatic lumbar stenosis with no preoperative radiological signs of instability will be recruited in a prospective trial and proposed for surgery: microsurgical decompression (MiD) or decompression and instrumented fusion (MiD + F). Clinical and mechanical outcomes of two different treatments (MiD vs. MiD+F) will be compared. An in-vitro biomechanical study will evaluate the biomechanical effect of the two surgical techniques. The aim of this project is to obtain robust data for tailoring the surgical approach to patient individual characteristics and needs, to gain the best clinical evidence, and possibly reducing the overall costs of management of this disease.

Conditions

• Lumbar Spinal Stenosis
• Degenerative Lumbar Spinal Stenosis

Interventions

Type	Name	Description
PROCEDURE	microsurgical decompression	decompression of neurological structures
PROCEDURE	decompression and instrumented fusion	decompression of neurological structures and spine stabilization

Timeline

• Start date: 2022-10-10
• Primary completion: 2024-12-15
• Completion: 2025-02-28
• First posted: 2024-03-28
• Last updated: 2026-02-11

Locations

2 sites across 1 country: Italy