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

  • STATUS
    Recruiting
  • End date
    Jun 20, 2023
  • participants needed
    198
  • sponsor
    Quanta Medical
Updated on 28 February 2022
discectomy

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.

Details
Condition Disk Herniated Lumbar
Treatment Discectomy, Insertion of INTRASPINE device
Clinical Study IdentifierNCT03752671
SponsorQuanta Medical
Last Modified on28 February 2022

Eligibility

Yes No Not Sure

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
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