Clinical trial NCT05527145: Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial
Official title: Treatment of Spinal Stenosis and Spolilolisthesis With Percutaneous Interspinous Spacers. A Phase III Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Spine Degeneration
Lumbar Spine Instability
Lumbar Spondylolisthesis
Lumbar Spinal Stenosis
Keywords: spondylolisthesis
lumbar spine stenosis
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: oswestry disability Index
timeFrame: 26 weeks
measure: oswestry disability Index
timeFrame: 52 weeks
Secondary outcomes:
measure: Euro Quality of life Five-Dimensional descriptive system questionnaire (EQ-5D)
timeFrame: 26 and 52 weeks
measure: Numeric Rating Scale (NRS)
timeFrame: 26 and 52 weeks
measure: subjective walking ability tool
timeFrame: 26 and 52 weeks
measure: neurophysiological measurements (NCSs/EMG)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza University of Rome, Policlinico Umberto I Hospital
Study officials:
References: