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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:

• Age 50-85 years.

• Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) indicating and motivating surgery. Numeric Rating Scale in lower limbs ≥3.

• MRI with finding of lumbar spinal stenosis at 1-3 lumbar levels. Dural sac area ≤75 mm2 or degree of stenosis C or D according to Schizas's classification.34

• The patient has given oral and written informed consent to participate.

Locations
Other Locations
Italy
Sapienza University of Rome, Policlinico Umberto I Hospital
RECRUITING
Rome
Contact Information
Primary
Alessandro napoli, md, phd
alessandro.napoli@uniroma1.it
+390649974521
Backup
silvia ciotti
silvia.ciotti@uniroma1.it
+390649974521
Time Frame
Start Date: 2024-09
Estimated Completion Date: 2026-07
Participants
Target number of participants: 200
Treatments
Active_comparator: surgery
Oper or minimally invasive surgery
Active_comparator: percutaneous
percutaneous non-surgical insertion of interspinous device
Related Therapeutic Areas
Sponsors
Leads: University of Roma La Sapienza

This content was sourced from clinicaltrials.gov