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

NCT05527145 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-02-12

No results posted yet for this study

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.

Conditions

  • Lumbar Spine Degeneration
  • Lumbar Spine Instability
  • Lumbar Spondylolisthesis
  • Lumbar Spinal Stenosis

Interventions

PROCEDURE

Minimally invasive surgery

Surgery with decompression. Central decompression of the stenotic segment with undercutting of the lateral recesses.

PROCEDURE

Percutaneous Spacer

percutaneous image guided outpatient procedure that enables interspinous spacer insertion and fusion

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-07-31
Completion
2026-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05527145 on ClinicalTrials.gov