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

NCT ID: NCT03752671

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2024-02-28

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.

Conditions

Disk Herniated Lumbar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

the IntraSPINE® device associated with discectomy

Group Type: EXPERIMENTAL

Insertion of INTRASPINE device

Intervention Type: DEVICE

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.

Discectomy

Intervention Type: PROCEDURE

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.

discectomy alone

Group Type: ACTIVE_COMPARATOR

Discectomy

Intervention Type: PROCEDURE

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.

Interventions

Insertion of INTRASPINE device

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.

Intervention Type: DEVICE

Discectomy

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.

Intervention Type: PROCEDURE

Other Intervention Names

Discectomy without insertion of INTRASPINE device

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cousin Biotech

INDUSTRY

Sponsor Role: collaborator

Quanta Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

George Pompidou European Hospital

Paris, Paris, France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 28242487 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29372860 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25288390 (View on PubMed)

Other Identifiers

2834_INTRASPINE_EC-EUROPE_16

Identifier Type: -

Identifier Source: org_study_id