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

Last updated: February 9, 2024
Sponsor: University of Roma La Sapienza
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Stenosis

Ankylosing Spondylitis

Spondylolisthesis

Treatment

Percutaneous Spacer

Minimally invasive surgery

Clinical Study ID

NCT05527145
URomLS-0137/22
  • Ages 50-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 50-85 years.
  2. Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) indicating andmotivating surgery. Numeric Rating Scale in lower limbs ≥3.
  3. MRI with finding of lumbar spinal stenosis at 1-3 lumbar levels. Dural sac area ≤75mm2 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

Exclusion Criteria:

  1. Degenerative deformity with Cobb angle >20°.
  2. Symptomatic osteoarthritis in the lower limbs that affects and limits the patient'sfunction.
  3. Arterial insufficiency (claudication intermittent).
  4. Former lumbar surgery other than disc hernia.
  5. Conditions that affect the spine, such as ankylosing spondylitis, diffuse idiopathicskeletal hyperostosis, spondylodiscitis/infections, malignancy and neurologicaldiseases.
  6. Heart and lung diseases presenting a significant risk for surgery or making itimpossible for the patient to take part in a percutaneous arm of treatment (AmericanSociety 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

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Percutaneous Spacer
Phase:
Study Start date:
September 01, 2024
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Sapienza University of Rome, Policlinico Umberto I Hospital

    Rome,
    Italy

    Active - Recruiting

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