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

NCT03752671 | Completed

• 1 other identifier: 2834_INTRASPINE_EC-EUROPE_16
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

  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

  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

  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

  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

  inclusion, 1 month, 6 months, 12 months and 24 months post-surgery

Study Arms (2)

the IntraSPINE® device associated with discectomy

EXPERIMENTAL

Device: Insertion of INTRASPINE device; Procedure: Discectomy

discectomy alone

ACTIVE COMPARATOR

Procedure: Discectomy

Interventions

Insertion of INTRASPINE device 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.

the IntraSPINE® device associated with discectomy

Discectomy 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.

Also known as: Discectomy without insertion of INTRASPINE device

discectomy alone; the IntraSPINE® device associated with discectomy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Quanta Medical: lead
• Cousin Biotech: collaborator

Study Sites (1)

George Pompidou European Hospital

Paris, Paris, 75015, France

Location

Related Publications (3)

• 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.

  PMID: 28242487 BACKGROUND

• 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.

  PMID: 29372860 BACKGROUND

• 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.

  PMID: 25288390 BACKGROUND

MeSH Terms

Interventions

Diskectomy

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be blinded to the randomisation arm. As the procedure is conducted under general anaesthesia, the patient will not be informed whether the procedure which was performed on him/her did or did not result in the implantation of the IntraSPINE® device (which is not visible on radiographs)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 26, 2018
• Study Start: May 20, 2019
• Primary Completion: June 2, 2021
• Study Completion: February 28, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)