Clinical trial NCT03752671: Efficacy and Safety of IntraSPINE® Associated with Discectomy in the Treatment of Lumbar Disc Herniation.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disk Herniated Lumbar
Lead sponsor: Quanta Medical
Sponsor class: INDUSTRY
Collaborators: name: Cousin Biotech
First posted: 2018-11-26
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: 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
timeFrame: All study period (24 months)
measure: 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
timeFrame: inclusion, 1 month, 6 months, 12 months and 24 months post-surgery
measure: 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
timeFrame: inclusion, 1 month, 6 months, 12 months and 24 months post-surgery
measure: Evolution between inclusion, 12 months and 24 months post-surgery in the two groups with regard to disc height
timeFrame: inclusion, 12 months and 24 months post-surgery
measure: Evolution between inclusion, 1month, 6 months, 12 months and 24 months post-surgery in the two groups with regard to quality of life
timeFrame: inclusion, 1 month, 6 months, 12 months and 24 months post-surgery
measure: Evolution between inclusion, 12 months and 24 months post-surgery in the two groups with regard to sagittal alignement
timeFrame: inclusion, 12 months and 24 months post-surgery
measure: Evolution between inclusion, 1 month, 6 months, 12 months and 24 months in the two groups with regard to neurological and motor status
timeFrame: inclusion, 1 month, 6 months, 12 months and 24 months
measure: Time to resumption of work post-surgery
timeFrame: 1 month, 6 months, 12 months and 24 months post-surgery
measure: Rates of further surgery at the level of the implant during the study
timeFrame: All study period (24 months)
measure: The number of adverse events (AE) reported, classified by type and organ.
timeFrame: All study period (24 months)
measure: The number of serious adverse events (SAE) reported, classified by type and organ.
timeFrame: All study period (24 months)
measure: Integrity of the implant: migration or wear
timeFrame: All study period (24 months)
measure: The peroperative complication rate.
timeFrame: All study period (24 months)
measure: The short and long term postoperative complication rate.
timeFrame: All study period (24 months)
Other outcomes:
Locations:
city: Paris
country: France
facility: George Pompidou European Hospital
Study officials:
References:
citation: Bae 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.
citation: 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.
citation: Galarza 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.