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NCT Number: NCT05527145

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

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Key information

Conditions

Lumbar Spine Degeneration Bone Diseases Lumbar Spinal Stenosis Lumbar Spine Instability Lumbar Spondylolisthesis Musculoskeletal Diseases Spinal Diseases Spinal Stenosis Spondylolisthesis Spondylolysis Spondylosis

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sapienza University of Rome, Policlinico Umberto I Hospital

Rome, Italy

Location status: Recruiting

Location contact

alessandro napoli, MD, PhD

CONTACT

[email protected]

+393357718114

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Minimally Invasive Surgery

Procedure

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

Percutaneous Spacer

Procedure

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

Primary outcomes

  1. oswestry disability Index

    Time frame: 26 weeks

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

  2. oswestry disability Index

    Time frame: 52 weeks

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

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)

    Time frame: 26 and 52 weeks

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

  3. subjective walking ability tool

    Time frame: 26 and 52 weeks

  4. neurophysiological measurements (NCSs/EMG)

    Time frame: 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro napoli, md, phd

CONTACT

[email protected]

+390649974521

silvia ciotti

CONTACT

[email protected]

+390649974521

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 2, 2022
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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