Lumbar Spine DegenerationNCT05527145
Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial
A study testing Minimally invasive surgery and Percutaneous Spacer in people with Lumbar Spine Degeneration and Lumbar Spine Instability, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Lumbar Spine Degeneration, Lumbar Spine Instability, Lumbar Spondylolisthesis
- What is being tested?
- Minimally invasive surgery and Percutaneous Spacer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Sapienza University of Rome, Policlinico Umberto I Hospital
Rome
alessandro napoli, MD, PhD, +393357718114, alessandro.napoli@uniroma1.it
About this study
Official title: Treatment of Spinal Stenosis and Spolilolisthesis With Percutaneous Interspinous Spacers. A Phase III 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.
Read the 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.
- Conditions
- Lumbar Spine Degeneration, Lumbar Spine Instability, Lumbar Spondylolisthesis, Lumbar Spinal Stenosis
- Being tested
- Minimally invasive surgery, Percutaneous Spacer
- Keywords
- spondylolisthesis, lumbar spine stenosis
- Medical subject headings
- Spondylolisthesis, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive surgeryProcedure or surgery
Surgery with decompression. Central decompression of the stenotic segment with undercutting of the lateral recesses.
Percutaneous SpacerProcedure or surgery
percutaneous image guided outpatient procedure that enables interspinous spacer insertion and fusion
| Study group | Role | What they receive |
|---|---|---|
| surgery | Active comparator | Oper or minimally invasive surgery Receives: Procedure: Minimally invasive surgery |
| percutaneous | Active comparator | percutaneous non-surgical insertion of interspinous device Receives: Procedure: Percutaneous Spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
oswestry disability Index
system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10%
Measured: 26 weeks
oswestry disability Index
system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10%
Measured: 52 weeks
Secondary outcomes (4)
Euro Quality of life Five-Dimensional descriptive system questionnaire (EQ-5D)
Measured: 26 and 52 weeks
Numeric Rating Scale (NRS)
for low back and leg pain (0-10 being 10 worst)
Measured: 26 and 52 weeks
subjective walking ability tool
Measured: 26 and 52 weeks
neurophysiological measurements (NCSs/EMG)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study startSep 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine DegenerationStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Napoli, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527145
- Sponsor's protocol ID
- URomLS-0137/22
- Status last verified
- Feb 2024
- First submitted
- 2 Aug 2022
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Spinal Stenosis and Spolilolisthesis With Percutaneous Interspinous Spacers. A Phase III Trial
- ClinicalTrials.gov ID
- NCT05527145
- Acronym / sponsor ID
- URomLS-0137/22
- Conditions
- Lumbar Spine Degeneration, Lumbar Spine Instability, Lumbar Spondylolisthesis, Lumbar Spinal Stenosis
- Keywords
- spondylolisthesis, lumbar spine stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| surgery | Active comparator | Procedure: Minimally invasive surgeryOper or minimally invasive surgery |
| percutaneous | Active comparator | Procedure: Percutaneous Spacerpercutaneous non-surgical insertion of interspinous device |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive surgerySurgery with decompression. Central decompression of the stenotic segment with undercutting of the lateral recesses. | Procedure or surgery | surgery |
| Percutaneous Spacerpercutaneous image guided outpatient procedure that enables interspinous spacer insertion and fusion | Procedure or surgery | percutaneous |
Primary outcome
oswestry disability Index
Time frame: 26 weeks
system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10%
oswestry disability Index
Time frame: 52 weeks
system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10%
4 secondary outcomes
Euro Quality of life Five-Dimensional descriptive system questionnaire (EQ-5D)
Time frame: 26 and 52 weeks
Numeric Rating Scale (NRS)
Time frame: 26 and 52 weeks
subjective walking ability tool
Time frame: 26 and 52 weeks
neurophysiological measurements (NCSs/EMG)
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive surgery and Percutaneous Spacer in people with Lumbar Spine Degeneration and Lumbar Spine Instability, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro napoli, md, phd (+390649974521, alessandro.napoli@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oswestry disability Index (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.