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Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial

Lumbar Spinal Stenosis Clinical Trial

Official title:
Treatment of Spinal Stenosis and Spolilolisthesis With Percutaneous Interspinous Spacers. A Phase III Trial

Clinical Trial Summary

Symptomatic lumbar spinal stenosis is the most common indication for spinal surgery. However, more than one-third of the patients undergoing surgery for lumbar stenosis report dissatisfaction with the results. On the other hand, conservative treatment has shown positive results in some cases. This trial will compare the outcomes of surgical versus non-surgical treatment for lumbar stenosis.

Clinical Trial Description

This is a three-centre randomised controlled trial in which 200 patients with symptomatic lumbar spinal stenosis will be randomised into one of two treatment arms. The patients in the surgical arm will undergo decompression of the neural structures by use of any open or minimally invasive (MIS) technique with or without fusion; the patients in the non-surgical arm will undergo imaging assisted percutaneous interspinous spacer insertion with fusion. The primary outcome of the study will be the Oswestry Disability Index. Secondary outcomes will include motor amplitude and degree of denervation activity obtained by means of nerve conduction studies and electromyography. Patient-reported outcome measures will be also used as secondary outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05527145
Study type Interventional
Source University of Roma La Sapienza
Contact Alessandro napoli, md, phd
Phone +390649974521
Email alessandro.napoli@uniroma1.it
Status Recruiting
Phase N/A
Start date September 2024
Completion date July 2026
View Details
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