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

NCT05527145 | Recruiting DMC

• 1 other identifier: URomLS-0137/22
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

spondylolisthesis; lumbar spine stenosis

Outcome Measures

Primary Outcomes (2)

• oswestry disability Index

  system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10%

  26 weeks

• oswestry disability Index

  system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10%

  52 weeks

Secondary Outcomes (4)

• Euro Quality of life Five-Dimensional descriptive system questionnaire (EQ-5D)

  26 and 52 weeks

• Numeric Rating Scale (NRS)

  26 and 52 weeks

• subjective walking ability tool

  26 and 52 weeks

• neurophysiological measurements (NCSs/EMG)

  52 weeks

Study Arms (2)

surgery

ACTIVE COMPARATOR

Oper or minimally invasive surgery

Procedure: Minimally invasive surgery

percutaneous

ACTIVE COMPARATOR

percutaneous non-surgical insertion of interspinous device

Procedure: Percutaneous Spacer

Interventions

Minimally invasive surgery PROCEDURE

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

surgery

Percutaneous Spacer PROCEDURE

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

percutaneous

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Degenerative deformity with Cobb angle \>20°.
• Symptomatic osteoarthritis in the lower limbs that affects and limits the patient's function.
• Arterial insufficiency (claudication intermittent).
• Former lumbar surgery other than disc hernia.
• Conditions that affect the spine, such as ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis, spondylodiscitis/infections, malignancy and neurological diseases.
• Heart and lung diseases presenting a significant risk for surgery or making it impossible for the patient to take part in a percutaneous arm of treatment (American Society of Anesthesiologists (ASA) score \>3).
• Polyneuropathies.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome, Policlinico Umberto I Hospital

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Spondylolisthesis; Spinal Stenosis

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Alessandro napoli, md, phd

CONTACT

+390649974521; alessandro.napoli@uniroma1.it

silvia ciotti

CONTACT

+390649974521; silvia.ciotti@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology and Interventional Radiology, Department of Radiological, Pathological and Oncological Sciences

Model Details: investigator-initiated, prospective, phase III, randomized, controlled clinical trial At the 6-month follow-up, there is a possibility of cross- over from group B to group A. After crossover to surgery, the after-treatment of these patients will be as in group A.

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: September 2, 2022
• Study Start: September 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

IT (1)