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

NACompletedINTERVENTIONAL
Enrollment

199

Participants

Timeline

Start Date

May 20, 2019

Primary Completion Date

June 2, 2021

Study Completion Date

February 28, 2024

Conditions
Disk Herniated Lumbar
Interventions
DEVICE

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."

PROCEDURE

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.

Trial Locations (1)

75015

George Pompidou European Hospital, Paris

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cousin Biotech

INDUSTRY

lead

Quanta Medical

INDUSTRY

NCT03752671 - Efficacy and Safety of IntraSPINE® Associated with Discectomy in the Treatment of Lumbar Disc Herniation. | Biotech Hunter | Biotech Hunter