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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Minimally invasive surgery

    Procedure/Surgery

    Surgery with decompression. Central decompression of the stenotic segment with undercutting of the lateral recesses.

  • Percutaneous Spacer

    Procedure/Surgery

    percutaneous image guided outpatient procedure that enables interspinous spacer insertion and fusion

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: surgeryActive comparator 1 intervention
Group B: percutaneousActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

oswestry disability Index

system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10%

Time frame
26 weeks
2

oswestry disability Index

system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10%

Time frame
52 weeks

Secondary outcomes

1

Euro Quality of life Five-Dimensional descriptive system questionnaire (EQ-5D)

Time frame
26 and 52 weeks
2

Numeric Rating Scale (NRS)

for low back and leg pain (0-10 being 10 worst)

Time frame
26 and 52 weeks
3

subjective walking ability tool

Time frame
26 and 52 weeks
4

neurophysiological measurements (NCSs/EMG)

Time frame
52 weeks

Other outcomes

Sponsors and contacts

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