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

Quanta Medical

Status: Completed

Conditions: Disk Herniated Lumbar

Treatments: Device: Insertion of INTRASPINE device; Procedure: Discectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03752671

2834_INTRASPINE_EC-EUROPE_16

Details and patient eligibility

About

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.

Enrollment: 199 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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199 participants in 2 patient groups

the IntraSPINE® device associated with discectomy

Experimental group

Treatment:

Procedure: Discectomy

Device: Insertion of INTRASPINE device

discectomy alone

Active Comparator group

Treatment:

Procedure: Discectomy