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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lumbar Spine Degeneration, Lumbar Spine Instability, Lumbar Spondylolisthesis, Lumbar Spinal Stenosis

Intervention / Treatment
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* Procedure: Minimally invasive surgery
* Procedure: Percutaneous Spacer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Psychological factors rendering the patient incapable of inclusion in the trial (eg, drug addiction, dementia).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spondylolisthesis, lumbar spine stenosis