Degenerative Spinal DiseaseFNSNCT03797144
Fenestrated Screw Study
A study testing CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement in people with Degenerative Spinal Disease and Deformity of Spine, run by Medtronic Spinal and Biologics at 6 sites in 5 countries.
Trial summary
The primary objective of this post-market study is to demonstrate that Oswestry disability index (ODI) score improved significantly at 12 months post-operatively as compared to baseline for each indication (degenerative spinal disease and deformity) in subjects with compromised bone quality, who will receive a… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Degenerative Spinal Disease, Deformity of Spine
- What is being tested?
- CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 18 Apr 2019to 15 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject must meet the following inclusion criteria to participate in this trial:
- One or more of the following diagnostic indications:
- Degenerative Spinal Disease (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis)
- Deformity (e.g. degenerative deformity)
- Degenerative Spinal Disease patients only: Patient has been unresponsive to non-operative treatment for at least three months or has progressive symptoms or signs of nerve root/spinal cord compression while undergoing continued non-operative management.
- Compromised bone quality defined as a hip DXA scan T-score less than or equal to -1.0 or spine quantitative CT (qCT) actual volumetric bone mineral density threshold of ≤ 120 mg/cm3.
Show all 11Show fewer
- Requires a procedure with an instrumented, posterior thoracic and/or lumbar spinal stabilization and/or immobilization.
- Is scheduled to receive a construct using CD Horizon® Spinal System components with at least one Fenestrated Screw cemented with Fenestrated Screw Cement.
- At least 22 years old or greater at the time of informed consent.
- Is able to understand and willing to sign the Patient Informed Consent Form.
- Is willing and able to undergo the study procedure and perform the follow up visits.
Who cannot join
- A subject will be excluded from participating in this trial for any of the following reasons:
- Has undergone stabilization and/or fusion procedure at the index or adjacent levels.
- Will undergo vertebroplasty or kyphoplasty procedure during surgery.
- Has been diagnosed with cauda equina syndrome.
- Has been previously diagnosed with clinically significant peripheral neuropathy.
- Has any degree of permanent neurologic deficit due to the presenting spinal disease (e.g. drop foot or gait deficit).
Show all 15Show fewer
- Has obesity defined by BMI greater than or equal to 35kg/m2.
- Has documented allergy to the materials that will be used in the surgical or any imaging procedure (e.g. titanium alloys, cobalt-chromium-molybdenum alloys and PMMA Fenestrated Screw Cement, contrast medium)
- Has overt or active bacterial infection, local or systemic, and/or potential for bacteremia.
- Has a non-correctable spontaneous or therapeutic coagulation disorder or history of coagulation disorder associated with bleeding.
- Has evolutive cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) nonreactive to medical treatment.
- Has any disease (e.g., neuromuscular disease, etc.) that would preclude the potential benefit and/or accurate clinical evaluation of the safety of the spinal implant surgery.
- Is pregnant or planning to become pregnant during the study duration.
- Is illiterate or considered vulnerable as per the Investigator's assessment (e.g., participants incapable of judgment, or participants under tutelage).
- Concurrent participation in another clinical study that may add additional safety risks and/or confound study results*.
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Greece2 sites
Mediterraneo Hospital
Athens, 16675
Athens Medical Center
Marousi, Athens, 15125
About this study
Official title: A Prospective, Multicenter Evaluation of the CD HORIZON® Fenestrated Screw Spinal System With Fenestrated Screw Cement When Used in the Treatment of Spinal Conditions in Subjects With Compromised Bone Quality
The primary objective of this post-market study is to demonstrate that Oswestry disability index (ODI) score improved significantly at 12 months post-operatively as compared to baseline for each indication (degenerative spinal disease and deformity) in subjects with compromised bone quality, who will receive a surgical procedure requiring posterior stabilization and/or immobilization of one or more spinal segments using CD HORIZON® Fenestrated Screw Spinal System with Fenestrated Screw Cement.
- Conditions
- Degenerative Spinal Disease, Deformity of Spine
- Being tested
- CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD HORIZON® Fenestrated Screw System with Fenestrated Screw CementDevice
The CD HORIZON® Legacy™ and Solera™ Fenestrated Screw Spinal System consists of a variety of cannulated screws with a series of fenestrations to allow polymethylmethacrylate (PMMA) bone cement (Fenestrated Screw Cement) to be injected into the treated site. The Fenestrated Screw Cement is used to augment screw fixation in subjects with compromised bone quality.
| Study group | Role | What they receive |
|---|---|---|
| Fenestrated Screw System | Experimental | Not described Receives: Device: CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline
Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections.
Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100.
The results are summarized for 21 subjects who were assessed at Baseline and 2 subjects who completed the 12 month follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 12 months time point.
Measured: Baseline to 12 months
Secondary outcomes (13)
Change in ODI From Baseline at 3 Months Visit
Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.
ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100.
The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point.
Measured: Baseline, 3 months
Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline
Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.
The 24 months follow-up visit did not have data collected and are not reported.
Measured: Baseline, 3, 12 months
Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline
The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit.
The 24 months follow-up visit did not have data collected and are not reported.
Measured: Baseline, 3, 12 months
Rate of Neurological Success at 12-month Visit
Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve).
Measured: Baseline to 12 months.
Rate of Intraoperative Cement Extravasation/Leakage. Patients
The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.
Measured: Surgery to 12 months.
Rate of Intraoperative Cement Extravasation/Leakage. Screws
The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.
Measured: Surgery to 12 months.
Device and/or Procedure Related Adverse Events Through 12 Months.
The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment
21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit.
Measured: Surgery to 12 months.
Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery
When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery.
Secondary spinal surgical procedures resulted from AE(s) could be classified into four categories: revision, removal, reoperation, and other.
One subject belonging to the Deformity group underwent a reoperation for a foraminal stenosis at index level L5-S1.
Measured: Surgery to 12 months.
Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit.
The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months.
The following were considered as signs of instrumentation instability:
- Screw pullout
- Screw loosening
- Screw toggle
Measured: Surgery to 12 months.
Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended.
The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays.
The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as "No fusion success". For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine.
Measured: Surgery to 12 months.
For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.
The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray:
- Sagittal alignment - Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL).
- Sagittal spinopelvic parameters: Pelvic Incidence (PI): Pelvic Tilt (PT) and Sacral Slope (SS)
Measured: Baseline to 12 months
For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit.
Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.
The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray:
- Coronal alignment : Distance between C7 plumb line and the central sacral vertical line
- Sagittal alignment - Global parameter: Sagittal vertical axis (SVA)
Measured: Baseline to 12 months
For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months
Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.
The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray:
- Coronal Curve Type
Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as:
- Curve type L: patients with a lumbar or thoracolumbar major curve >30˚ (apical level of T10 or lower)
- Curve type T: patients with a thoracic major curve of >30˚ (apical level of T9 or higher)
- Curve type D: patients with a double major curve, with each curve >30˚.
- Curve type N: patients with no coronal curve >30˚.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start18 Apr 2019
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Why it stopped: Delay in enrollment as compared to plan (impacted by COVID-19 pandemic) and availability of data from other data sources to support the products in scope.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Degenerative Spinal DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797144
- Sponsor's protocol ID
- MDT17040SD1703
- Acronym
- FNS
- Status last verified
- Jul 2021
- First submitted
- 14 Dec 2018
- Last updated
- 24 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Evaluation of the CD HORIZON® Fenestrated Screw Spinal System With Fenestrated Screw Cement When Used in the Treatment of Spinal Conditions in Subjects With Compromised Bone Quality
- ClinicalTrials.gov ID
- NCT03797144
- Acronym / sponsor ID
- FNS / MDT17040SD1703
- Conditions
- Degenerative Spinal Disease, Deformity of Spine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Delay in enrollment as compared to plan (impacted by COVID-19 pandemic) and availability of data from other data sources to support the products in scope.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 9 Jan 2019 (actual)
- Results
- Posted 24 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this post-market study is to demonstrate that Oswestry disability index (ODI) score improved significantly at 12 months post-operatively as compared to baseline for each indication (degenerative spinal disease and deformity) in subjects with compromised bone quality, who will receive a surgical procedure requiring posterior stabilization and/or immobilization of one or more spinal segments using CD HORIZON® Fenestrated Screw Spinal System with Fenestrated Screw Cement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fenestrated Screw System | Experimental | Device: CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- One or more of the following diagnostic indications:
- Degenerative Spinal Disease patients only: Patient has been unresponsive to non-operative treatment for at least three months or has progressive symptoms or signs of nerve root/spinal cord compression while undergoing continued non-operative management.
- Compromised bone quality defined as a hip DXA scan T-score less than or equal to -1.0 or spine quantitative CT (qCT) actual volumetric bone mineral density threshold of ≤ 120 mg/cm3.
- Requires a procedure with an instrumented, posterior thoracic and/or lumbar spinal stabilization and/or immobilization.
- Is scheduled to receive a construct using CD Horizon® Spinal System components with at least one Fenestrated Screw cemented with Fenestrated Screw Cement.
Key exclusion criteria (15 listed)
- A subject will be excluded from participating in this trial for any of the following reasons:
- Has undergone stabilization and/or fusion procedure at the index or adjacent levels.
- Will undergo vertebroplasty or kyphoplasty procedure during surgery.
- Has been diagnosed with cauda equina syndrome.
- Has been previously diagnosed with clinically significant peripheral neuropathy.
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 |
|---|---|---|
| CD HORIZON® Fenestrated Screw System with Fenestrated Screw CementThe CD HORIZON® Legacy™ and Solera™ Fenestrated Screw Spinal System consists of a variety of cannulated screws with a series of fenestrations to allow polymethylmethacrylate (PMMA) bone cement (Fenestrated Screw Cement) to be injected into the treated site. The Fenestrated Screw Cement is used to augment screw fixation in subjects with compromised bone quality. | Device | Fenestrated Screw System |
Primary outcome
Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline
Time frame: Baseline to 12 months
Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed at Baseline and 2 subjects who completed the 12 month follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 12 months time point.
13 secondary outcomes
Change in ODI From Baseline at 3 Months Visit
Time frame: Baseline, 3 months
Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline
Time frame: Baseline, 3, 12 months
Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline
Time frame: Baseline, 3, 12 months
Rate of Neurological Success at 12-month Visit
Time frame: Baseline to 12 months.
Rate of Intraoperative Cement Extravasation/Leakage. Patients
Time frame: Surgery to 12 months.
Rate of Intraoperative Cement Extravasation/Leakage. Screws
Time frame: Surgery to 12 months.
Device and/or Procedure Related Adverse Events Through 12 Months.
Time frame: Surgery to 12 months.
Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery
Time frame: Surgery to 12 months.
Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit.
Time frame: Surgery to 12 months.
Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended.
Time frame: Surgery to 12 months.
For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
Time frame: Baseline to 12 months
For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit.
Time frame: Baseline to 12 months
For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Degenerative Spinal Disease
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Not yet recruiting
Conservative Care Versus Decompression Trial for Degenerative Cervical Myelopathy Pilot
Degenerative Cervical Myelopathy
Recruiting
Effect of Irrigation Pressure on Postoperative Complications and Surgical Field Clarity in Unilateral Biportal Endoscopic Surgery
Lumbar Disc Herniation, Lumbar Spinal Stenosis
RecruitingPhase 1/2
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
Degenerative Disc Disease, Lumbar Disc Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement in people with Degenerative Spinal Disease and Deformity of Spine, run by Medtronic Spinal and Biologics at 6 sites in 5 countries.
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 11 inclusion and 15 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: stopped early, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Greece, Belgium, Finland, France, 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?
Yes. Results are posted in the registry (first posted 24 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline (time frame: Baseline to 12 months). 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 24 Aug 2021; AzTrials last refreshed its copy on 27 Oct 2026.