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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorUniversity of Roma La Sapienza

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Minimally invasive surgery
  • Percutaneous Spacer

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators