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

Primary Purpose

Lumbar Spine Degeneration, Lumbar Spine Instability, Lumbar Spondylolisthesis

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Minimally invasive surgery

Percutaneous Spacer

About this trial

This is an interventional treatment trial for Lumbar Spine Degeneration focused on measuring spondylolisthesis, lumbar spine stenosis

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Sapienza University of Rome, Policlinico Umberto I HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

surgery

percutaneous

Arm Description

Oper or minimally invasive surgery

percutaneous non-surgical insertion of interspinous device

Outcomes

Primary Outcome Measures

oswestry disability Index

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

oswestry disability Index

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

Secondary Outcome Measures

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

Numeric Rating Scale (NRS)

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

subjective walking ability tool

neurophysiological measurements (NCSs/EMG)

Full Information

NCT ID

NCT05527145

First Posted

August 2, 2022

Last Updated

September 1, 2022

Sponsor

University of Roma La Sapienza

1. Study Identification

Unique Protocol Identification Number

NCT05527145

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 2022 (Anticipated)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

spondylolisthesis, lumbar spine stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

surgery

Arm Type

Active Comparator

Arm Description

Oper or minimally invasive surgery

Arm Title

percutaneous

Arm Type

Active Comparator

Arm Description

percutaneous non-surgical insertion of interspinous device

Intervention Type

Procedure

Intervention Name(s)

Minimally invasive surgery

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Percutaneous Spacer

Intervention Description

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

Primary Outcome Measure Information:

Title

oswestry disability Index

Description

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

Time Frame

26 weeks

Title

oswestry disability Index

Description

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

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

26 and 52 weeks

Title

Numeric Rating Scale (NRS)

Description

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

Time Frame

26 and 52 weeks

Title

subjective walking ability tool

Time Frame

26 and 52 weeks

Title

neurophysiological measurements (NCSs/EMG)

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alessandro napoli, md, phd

Phone

+390649974521

alessandro.napoli@uniroma1.it

First Name & Middle Initial & Last Name or Official Title & Degree

silvia ciotti

Phone

+390649974521

silvia.ciotti@uniroma1.it

Facility Information:

Facility Name

Sapienza University of Rome, Policlinico Umberto I Hospital

City

Rome

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

alessandro napoli, MD, PhD

Phone

+393357718114

alessandro.napoli@uniroma1.it

12. IPD Sharing Statement

Learn more about this trial

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

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