Disk Herniated LumbarINTREURNCT03752671
Efficacy and Safety of IntraSPINE® Associated With Discectomy in the Treatment of Lumbar Disc Herniation.
A study testing Insertion of INTRASPINE device and Discectomy in people with Disk Herniated Lumbar, run by Quanta Medical at 1 site in France.
Trial summary
IntraSPINE® is a novel device that, unlike interspinous positioned implants, is unique in being placed more anteriorly in an interlaminar position, closer to the normal center of rotation of the motion segment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Disk Herniated Lumbar
- What is being tested?
- Insertion of INTRASPINE device and Discectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2019to 28 Feb 2024
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease-related criteria:
- single segment L4-L5 or L5-S1 lumbar disc hernia identified on imaging (lumbar spine MRI)
- median or posterolateral disc hernia.
- failure of correct medical treatment which has not provided lasting symptom relief absence of contraindications to surgical discectomy and implantation of the IntraSPINE®.
- Population related criteria:
- subjects of either sex and over 18 years old
Show all 9Show fewer
- who have given their free informed signed consent to participate in the study
- patients who are able to respond to the questionnaires and who can communicate in the language of the study country
- and who are affiliated to a social security system or have rights from a social security system.
Who cannot join
- Disease-related criteria:
- recurrent disc hernia post-discectomy at any level
- foraminal and extra-foraminal disc hernia
- paralysing disc hernia (score of 3/5 or less) and cauda equina syndrome
- any grade of spondylolisthesis
- degenerative scoliosis ≥ 15°
Show all 23Show fewer
- osteoporosis or Paget's disease
- BMI > 30
- procedure required on more than one vertebral level
- endoscopic microdiscectomy prohibiting insertion of the IntraSPINE®
- chronic infection
- systemic or metabolic disorders
- active ongoing malignant disease (liable to prevent the study being conducted and does not carry a risk of vertebral lysis)
- occupational disorder responsible for the disease Treatment or device-related criteria
- allergy to any of the constituents of the medical device
- Population-related criteria:
- past history of spinal procedure.
- withdrawal of consent
- pregnant women
- breast-feeding women
- participation in a clinical study within 3 months before the initial visit.
- drug addiction
- predictable lack of availability during the study. Patients deprived of their freedom or under legal guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of the Inter-laminar Device IntraSPINE® Associated With Discectomy in the Treatment of Lumbar Disc Herniation. A Single-blind, Randomised, Comparative, Multicentre Clinical Trial vs. Discectomy Alone.
IntraSPINE® is a novel device that, unlike interspinous positioned implants, is unique in being placed more anteriorly in an interlaminar position, closer to the normal center of rotation of the motion segment. Mechanical advantages are thus conferred over more posteriorly positioned devices through the possibility of more physiological 'rocking' type movements in flexion and extension . This enables IntraSPINE® to off-load the facet joints in extension without blocking movement. Having a more anteriorly placed fulcrum also helps control excessive flexion movements by virtue of an improved lever arm in conjunction with an intact posterior tension band.
The underlying hypothesis of this work is that a clinical gain is achieved by adding an IntraSPINE® interlaminar device to discectomy in patients suffering from a lumbar disc herniation. This should result in an improvement in incapacity level and a reduction in pain.
- Conditions
- Disk Herniated Lumbar
- Being tested
- Insertion of INTRASPINE device, Discectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of INTRASPINE deviceDevice
The surgical technique for excision of the disc hernia is the surgeon's usual technique: patient positioning (lying on his/her back or front or in the knee to chest position) the approach to the lumbar disc hernia (interlaminar or interspinous), closure and drainage of the operation site are performed by the surgeon's usual practice.
IntraSPINE® is positioned once surgery for the disc hernia has been performed. The implant bed is prepared with the assistance of the distractor provided. The choice of implant size is made after positioning the trial device corresponding to the anatomical bed. Once the size has been established the corresponding implant is placed in a cup of physiological saline prior to implantation. Implantation is performed using the appropriate implant holder.
DiscectomyProcedure or surgery
Also called Discectomy without insertion of INTRASPINE device
The surgical technique for excision of the disc hernia is the surgeon's usual technique: patient positioning (lying prone or supine or in the knee to chest position). The approach to the lumbar disc hernia (interlaminar or interspinous), closure and drainage of the operation site are performed using the surgeon's normal practice.
| Study group | Role | What they receive |
|---|---|---|
| the IntraSPINE® device associated with discectomy | Experimental | Not described Receives: Device: Insertion of INTRASPINE device; Procedure: Discectomy |
| discectomy alone | Active comparator | Not described Receives: Procedure: Discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to 12 months of the degree of functional disability associated with lumbar pain will be measured using the Oswestry Disability Index
The Oswestry questionnaire provides an assessment of the symptoms and severity of the back pain and repercussions on activities of daily living. The questionnaire contains 10 questions concerning: pain, personal care, carrying loads, walking, seated position, standing position, sleep, sex life, social life and travel. Each question offers six answers with a score of 0 to 6 which the patient must select: a score of 0 represents normal function and a score of 6 represents greatly reduced function.
The score obtained is multiplied by 2 in order to obtain a percentage handicap, with 0% for no handicap and 100% for the greatest handicap. It takes approximately 5 minutes to complete the test.
Measured: Baseline and 12 months
Secondary outcomes (14)
The effect of the IntraSPINE® device associated with discectomy versus discectomy alone in the treatment of lumbar disc herniation with regard to recurrence of disc herniation during the study
recurrence will be defined as the occurrence of disc herniation confirmed by imaging(MRI) or following surgery at the instrumented level in patients undergoing further surgery during the course of the study. This definition enables the inclusion of all hernias (both symptomatic and asymptomatic).
Measured: All study period (24 months)
Evolution between inclusion, 1, 6,12 and 24 months post-surgery of the degree of functional disability like symptoms and severity of back pain and repercussions on activities of daily living associated with lumbar pain using the Oswestry Disability Index
The Oswestry questionnaire provides an assessment of the symptoms and severity of the back pain and repercussions on activities of daily living. The questionnaire contains 10 questions concerning: pain, personal care, carrying loads, walking, seated position, standing position, sleep, sex life, social life and travel. Each question offers six answers with a score of 0 to 6 which the patient must select: a score of 0 represents normal function and a score of 6 represents greatly reduced function.
The score obtained is multiplied by 2 in order to obtain a percentage handicap, with 0% for no handicap and 100% for the greatest handicap. It takes approximately 5 minutes to complete the test.
The Oswestry Disability Index will be measured at inclusion and at 1 month, 6 months, 12 months and 24 months after surgery.
Measured: inclusion, 1 month, 6 months, 12 months and 24 months post-surgery
Evolution between inclusion, 1 month, 6 months, 12 months and 24 months post-surgery in the two groups with regard to lumbar and radicular pain using a Visual Analogic Scale
Radicular and lumbar pain will be assessed on a Visual Analogic Scale at inclusion, 1 month, 6 months, 12 months and 24 months post-surgery. The visual analogue scale is a graduated ruler from 0 to 10 cm where 0 indicates that the subject has no pain and 10 cm represents the maximum pain the subject can tolerate. It is a self-assessment scale and is sensitive, reproducible, reliable and validated both in acute pain and chronic pain situations.
Measured: inclusion, 1 month, 6 months, 12 months and 24 months post-surgery
Evolution between inclusion, 12 months and 24 months post-surgery in the two groups with regard to disc height
Disc height (anterior and posterior) will be measured at inclusion, 12 months and 24 months post-surgery based on full-spine x-rays
Measured: inclusion, 12 months and 24 months post-surgery
Evolution between inclusion, 1month, 6 months, 12 months and 24 months post-surgery in the two groups with regard to quality of life
Quality of life will be assessed using the 12-Item Short Form Survey (SF-12) score at inclusion, 1 month, 6 months, 12 months and 24 months post-surgery.The SF-12 test is a shortened version of the "Medical Outcomes Study Short-Form General Health Survey" (SF 36) which only includes 12 of the 36 questions. The SF 12 provides two scores: a mental and social quality of life score and a physical quality of life score. The SF-12 summary scores range from 0 to 100 with higher scores representing better self-reported health
Measured: inclusion, 1 month, 6 months, 12 months and 24 months post-surgery
Evolution between inclusion, 12 months and 24 months post-surgery in the two groups with regard to sagittal alignement
Sagittal alignment will be measured at inclusion, 12 months and 24 months post-surgery by lateral x-ray (full spine).
Measured: inclusion, 12 months and 24 months post-surgery
Evolution between inclusion, 1 month, 6 months, 12 months and 24 months in the two groups with regard to neurological and motor status
Neurological and motor status will be assessed at inclusion, 1 month, 6 months, 12 months and 24 months post-surgery using the AIS scale (ASIA "American Spinal Injury Association" Impairment Scale): the section concerning ponytail syndrome will be included in the evaluation.The AIS measurement scale (ASIA "American Spinal Injury Association" Impairment Scale), based on the Frankel Scale is a scale administered by the clinician used to classify the severity of the lesions of patients who have spinal lesions. It is a 5 point ordinal scale and classifies people from A "complete lesions" to E "normal sensory and motor functions"
Measured: inclusion, 1 month, 6 months, 12 months and 24 months
Time to resumption of work post-surgery
The time to resumption of work following surgery will be evaluated in terms of the number of days between hospitalisation and resumption of activity and by the number of days off work due to the disease for which the operation was performed during the 24-month follow-up period.
Measured: 1 month, 6 months, 12 months and 24 months post-surgery
Rates of further surgery at the level of the implant during the study
The revision surgery rate (Re intervention or further surgery) . Further surgery throughout the duration of the study is defined as a second operation at the instrumented level (level of the implant performed ) during the course of the study, regardless of reason (i.e. infectious or mechanical): revision, implant removal (explantation), fusion, need for additional fixation, or any surgery affecting any part of the device or relating to any associated complications
Measured: All study period (24 months)
The number of adverse events (AE) reported, classified by type and organ.
The safety and tolerability end points will be will be as follows:
The number of adverse events (AE) reported, classified by type and organ.
Measured: All study period (24 months)
The number of serious adverse events (SAE) reported, classified by type and organ.
The safety and tolerability end points will be will be as follows:
The number of serious adverse events (SAE) reported, classified by type and organ.
Measured: All study period (24 months)
Integrity of the implant: migration or wear
The safety and tolerability end points will be will be as follows:
Integrity of the implant: migration or wear.
Measured: All study period (24 months)
The peroperative complication rate.
The safety and tolerability end points will be will be as follows:
The peroperative complication rate.
Measured: All study period (24 months)
The short and long term postoperative complication rate.
The safety and tolerability end points will be will be as follows:
The short and long term postoperative complication rate.
Measured: All study period (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start20 May 2019
- Primary completion2 Jun 2021
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Disk Herniated LumbarStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quanta Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cousin Biotech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752671
- Sponsor's protocol ID
- 2834_INTRASPINE_EC-EUROPE_16
- Acronym
- INTREUR
- Status last verified
- Mar 2025
- First submitted
- 16 Nov 2018
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmidt S, Franke J, Rauschmann M, Adelt D, Bonsanto MM, Sola S. Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization. J Neurosurg Spine. 2018 Apr;28(4):406-415. doi: 10.3171/2017.11.SPINE17643. Epub 2018 Jan 26.
PubMed 29372860Galarza M, Gazzeri R, De la Rosa P, Martinez-Lage JF. Microdiscectomy with and without insertion of interspinous device for herniated disc at the L5-S1 level. J Clin Neurosci. 2014 Nov;21(11):1934-9. doi: 10.1016/j.jocn.2014.02.029. Epub 2014 Oct 3.
PubMed 25288390Bae J, Lee SM, Lee SH, Shin SH, Kim HJ, Kim KH. The Likelihood of Reaching Substantial Clinical Benefit After an Interlaminar Dynamic Spacer for Chronic Low Back Pain: A Clinical and Radiologic Analysis of a Prospective Cohort. World Neurosurg. 2017 May;101:589-598. doi: 10.1016/j.wneu.2017.02.083. Epub 2017 Feb 27.
PubMed 28242487
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Inter-laminar Device IntraSPINE® Associated With Discectomy in the Treatment of Lumbar Disc Herniation. A Single-blind, Randomised, Comparative, Multicentre Clinical Trial vs. Discectomy Alone.
- ClinicalTrials.gov ID
- NCT03752671
- Acronym / sponsor ID
- INTREUR / 2834_INTRASPINE_EC-EUROPE_16
- Conditions
- Disk Herniated Lumbar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Quanta MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Cousin Biotech
- Study start
- 20 May 2019 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 26 Nov 2018 (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.
IntraSPINE® is a novel device that, unlike interspinous positioned implants, is unique in being placed more anteriorly in an interlaminar position, closer to the normal center of rotation of the motion segment. Mechanical advantages are thus conferred over more posteriorly positioned devices through the possibility of more physiological 'rocking' type movements in flexion and extension . This enables IntraSPINE® to off-load the facet joints in extension without blocking movement. Having a more anteriorly placed fulcrum also helps control excessive flexion movements by virtue of an improved lever arm in conjunction with an intact posterior tension band.
The underlying hypothesis of this work is that a clinical gain is achieved by adding an IntraSPINE® interlaminar device to discectomy in patients suffering from a lumbar disc herniation. This should result in an improvement in incapacity level and a reduction in pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the IntraSPINE® device associated with discectomy | Experimental | Device: Insertion of INTRASPINE device, Procedure: Discectomy |
| discectomy alone | Active comparator | Procedure: Discectomy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- single segment L4-L5 or L5-S1 lumbar disc hernia identified on imaging (lumbar spine MRI)
- median or posterolateral disc hernia.
- failure of correct medical treatment which has not provided lasting symptom relief absence of contraindications to surgical discectomy and implantation of the IntraSPINE®.
- subjects of either sex and over 18 years old
- who have given their free informed signed consent to participate in the study
Key exclusion criteria (23 listed)
- recurrent disc hernia post-discectomy at any level
- foraminal and extra-foraminal disc hernia
- paralysing disc hernia (score of 3/5 or less) and cauda equina syndrome
- any grade of spondylolisthesis
- degenerative scoliosis ≥ 15°
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 |
|---|---|---|
| Insertion of INTRASPINE deviceThe surgical technique for excision of the disc hernia is the surgeon's usual technique: patient positioning (lying on his/her back or front or in the knee to chest position) the approach to the lumbar disc hernia (interlaminar or interspinous), closure and drainage of the operation site are performed by the surgeon's usual practice. IntraSPINE® is positioned once surgery for the disc hernia has been performed. The implant bed is prepared with the assistance of the distractor provided. The choice of implant size is made after positioning the trial device corresponding to the anatomical bed. Once the size has been established the corresponding implant is placed in a cup of physiological saline prior to implantation. Implantation is performed using the appropriate implant holder. | Device | the IntraSPINE® device associated with discectomy |
| DiscectomyAlso: Discectomy without insertion of INTRASPINE deviceThe surgical technique for excision of the disc hernia is the surgeon's usual technique: patient positioning (lying prone or supine or in the knee to chest position). The approach to the lumbar disc hernia (interlaminar or interspinous), closure and drainage of the operation site are performed using the surgeon's normal practice. | Procedure or surgery | discectomy alone, the IntraSPINE® device associated with discectomy |
Primary outcome
Change from Baseline to 12 months of the degree of functional disability associated with lumbar pain will be measured using the Oswestry Disability Index
Time frame: Baseline and 12 months
The Oswestry questionnaire provides an assessment of the symptoms and severity of the back pain and repercussions on activities of daily living. The questionnaire contains 10 questions concerning: pain, personal care, carrying loads, walking, seated position, standing position, sleep, sex life, social life and travel. Each question offers six answers with a score of 0 to 6 which the patient must select: a score of 0 represents normal function and a score of 6 represents greatly reduced function. The score obtained is multiplied by 2 in order to obtain a percentage handicap, with 0% for no handicap and 100% for the greatest handicap. It takes approximately 5 minutes to complete the test.
14 secondary outcomes
The effect of the IntraSPINE® device associated with discectomy versus discectomy alone in the treatment of lumbar disc herniation with regard to recurrence of disc herniation during the study
Time frame: All study period (24 months)
Evolution between inclusion, 1, 6,12 and 24 months post-surgery of the degree of functional disability like symptoms and severity of back pain and repercussions on activities of daily living associated with lumbar pain using the Oswestry Disability Index
Time frame: inclusion, 1 month, 6 months, 12 months and 24 months post-surgery
Evolution between inclusion, 1 month, 6 months, 12 months and 24 months post-surgery in the two groups with regard to lumbar and radicular pain using a Visual Analogic Scale
Time frame: inclusion, 1 month, 6 months, 12 months and 24 months post-surgery
Evolution between inclusion, 12 months and 24 months post-surgery in the two groups with regard to disc height
Time frame: inclusion, 12 months and 24 months post-surgery
Evolution between inclusion, 1month, 6 months, 12 months and 24 months post-surgery in the two groups with regard to quality of life
Time frame: inclusion, 1 month, 6 months, 12 months and 24 months post-surgery
Evolution between inclusion, 12 months and 24 months post-surgery in the two groups with regard to sagittal alignement
Time frame: inclusion, 12 months and 24 months post-surgery
Evolution between inclusion, 1 month, 6 months, 12 months and 24 months in the two groups with regard to neurological and motor status
Time frame: inclusion, 1 month, 6 months, 12 months and 24 months
Time to resumption of work post-surgery
Time frame: 1 month, 6 months, 12 months and 24 months post-surgery
Rates of further surgery at the level of the implant during the study
Time frame: All study period (24 months)
The number of adverse events (AE) reported, classified by type and organ.
Time frame: All study period (24 months)
The number of serious adverse events (SAE) reported, classified by type and organ.
Time frame: All study period (24 months)
Integrity of the implant: migration or wear
Time frame: All study period (24 months)
The peroperative complication rate.
Time frame: All study period (24 months)
The short and long term postoperative complication rate.
Time frame: All study period (24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Background: PubMed 29372860Schmidt S, Franke J, Rauschmann M, Adelt D, Bonsanto MM, Sola S. Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization. J Neurosurg Spine. 2018 Apr;28(4):406-415. doi: 10.3171/2017.11.SPINE17643. Epub 2018 Jan 26.
- Background: PubMed 25288390Galarza M, Gazzeri R, De la Rosa P, Martinez-Lage JF. Microdiscectomy with and without insertion of interspinous device for herniated disc at the L5-S1 level. J Clin Neurosci. 2014 Nov;21(11):1934-9. doi: 10.1016/j.jocn.2014.02.029. Epub 2014 Oct 3.
- Results publication: PubMed 28242487Bae J, Lee SM, Lee SH, Shin SH, Kim HJ, Kim KH. The Likelihood of Reaching Substantial Clinical Benefit After an Interlaminar Dynamic Spacer for Chronic Low Back Pain: A Clinical and Radiologic Analysis of a Prospective Cohort. World Neurosurg. 2017 May;101:589-598. doi: 10.1016/j.wneu.2017.02.083. Epub 2017 Feb 27.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of INTRASPINE device and Discectomy in people with Disk Herniated Lumbar, run by Quanta Medical at 1 site in France.
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 9 inclusion and 23 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: finished, as of the sponsor's last update on 20 Mar 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from Baseline to 12 months of the degree of functional disability associated with lumbar pain will be measured using the Oswestry Disability Index (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03752671, which also lists 3 linked publications.
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 20 Mar 2025.