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

Not Applicable

Recruiting

• Conditions: Lumbar Spine Instability; Lumbar Spondylolisthesis; Lumbar Spine Degeneration; Lumbar Spinal Stenosis
• Interventions: Procedure: Percutaneous Spacer; Procedure: Minimally invasive surgery

• Registration Number: NCT05527145
• Lead Sponsor: University of Roma La Sapienza

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.

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 Timeline

• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12
• Study Start: 2024-09
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
percutaneous	Percutaneous Spacer	percutaneous non-surgical insertion of interspinous device
surgery	Minimally invasive surgery	Oper or minimally invasive surgery

Primary Outcome Measures

Name	Time	Method
oswestry disability Index	52 weeks	system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10%

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sapienza University of Rome, Policlinico Umberto I Hospital; 🇮🇹 Rome, Italy