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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05527145
• Other study ID #: URomLS-0137/22
• Status: Recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: July 2026

Study information

• Verified date: February 2024
• Source: University of Roma La Sapienza
• Contact: Alessandro napoli, md, phd
• Phone: +390649974521
• Email: alessandro.napoli[@]uniroma1.it
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Lumbar Spine Degeneration
• Lumbar Spine Instability
• Lumbar Spondylolisthesis
• Spinal Stenosis
• Spondylolisthesis

Intervention

Procedure:
• Minimally invasive surgery
Surgery with decompression. Central decompression of the stenotic segment with undercutting of the lateral recesses.
• Percutaneous Spacer
percutaneous image guided outpatient procedure that enables interspinous spacer insertion and fusion

Locations

Country	Name	City	State
Italy	Sapienza University of Rome, Policlinico Umberto I Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oswestry disability Index	system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10%	26 weeks
Primary	oswestry disability Index	system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10%	52 weeks
Secondary	Euro Quality of life Five-Dimensional descriptive system questionnaire (EQ-5D)		26 and 52 weeks
Secondary	Numeric Rating Scale (NRS)	for low back and leg pain (0-10 being 10 worst)	26 and 52 weeks
Secondary	subjective walking ability tool		26 and 52 weeks
Secondary	neurophysiological measurements (NCSs/EMG)		52 weeks