Efficacy and Safety of IntraSPINE® Associated With Discectomy in the Treatment of Lumbar Disc Herniation.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Disk Herniated Lumbar

Intervention / Treatment
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* Device: Insertion of INTRASPINE device
* Procedure: Discectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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. Exclusion Criteria: 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° 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the IntraSPINE® device associated with discectomy<br> | Device: Insertion of INTRASPINE device<br>* 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.<br>Procedure: Discectomy<br>* 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.<br>* Other names: Discectomy without insertion of INTRASPINE device;|
| Active Comparator: discectomy alone<br> | Procedure: Discectomy<br>* 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.<br>* Other names: Discectomy without insertion of INTRASPINE device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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 | 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 | 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). | 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 | 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. | 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 | 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. | 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. | 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. | 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. | 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. | All study period (24 months) |