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

Lumbar Spinal Stenosis Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06335511
Study type Observational
Source Azienda Usl di Bologna
Contact Alfredo Conti, Prof.
Phone +393382131017
Email alfredo.conti2@unibo.it
Status Recruiting
Phase
Start date October 10, 2022
Completion date February 28, 2025
View Details
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