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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Spinal Stenosis; Lumbar Spondylolisthesis; Lumbar Spine Degeneration; Lumbar Spine Instability
• Intervention / Treatment: Procedure: Minimally invasive surgery; Procedure: Percutaneous Spacer

Detailed 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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessandro napoli, md, phd; Phone Number: +390649974521; Email: alessandro.napoli@uniroma1.it
• Study Contact Backup: Name: silvia ciotti; Phone Number: +390649974521; Email: silvia.ciotti@uniroma1.it

Study Locations

• Italy
  • Rome, Italy
    • Recruiting
    • Sapienza University of Rome, Policlinico Umberto I Hospital
    • Contact: alessandro napoli, MD, PhD; Phone Number: +393357718114; Email: alessandro.napoli@uniroma1.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 50-85 years.
2. Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) indicating and motivating surgery. Numeric Rating Scale in lower limbs ≥3.
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
4. The patient has given oral and written informed consent to participate.

Exclusion Criteria:

1. Degenerative deformity with Cobb angle >20°.
2. Symptomatic osteoarthritis in the lower limbs that affects and limits the patient's function.
3. Arterial insufficiency (claudication intermittent).
4. Former lumbar surgery other than disc hernia.
5. Conditions that affect the spine, such as ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis, spondylodiscitis/infections, malignancy and neurological diseases.
6. 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).
7. Polyneuropathies.
8. Psychological factors rendering the patient incapable of inclusion in the trial (eg, drug addiction, dementia).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: surgery; Oper or minimally invasive surgery	Procedure: Minimally invasive surgery; Surgery with decompression. Central decompression of the stenotic segment with undercutting of the lateral recesses.
Active Comparator: percutaneous; percutaneous non-surgical insertion of interspinous device	Procedure: Percutaneous Spacer; percutaneous image guided outpatient procedure that enables interspinous spacer insertion and fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Euro Quality of life Five-Dimensional descriptive system questionnaire (EQ-5D)		26 and 52 weeks
Numeric Rating Scale (NRS)	for low back and leg pain (0-10 being 10 worst)	26 and 52 weeks
subjective walking ability tool		26 and 52 weeks
neurophysiological measurements (NCSs/EMG)		52 weeks

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: spondylolisthesis; lumbar spine stenosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Constriction, Pathologic; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: URomLS-0137/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No