Long-Term Evaluation of the Performance and Safety of the IntraSPINE® Interlaminar Implant in the Treatment of Lumbar Degenerative Disc Disease
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY
This is an observational study designed as an extension of a prospective study conducted between 2012 and 2017. Patients who were originally enrolled in the initial study are being recontacted for follow-up assessment, including evaluation of clinical and radiological (MRI) criteria. Approximately 50 patients have been included to date and their long terms results (at least 9 years) will be assessed.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult patient,
• Patient with degenerative lumbar disc disease at one or two levels for whom
• Surgery involving the placement of an IntraSPINE® implant has been indicated following the failure of conservative treatment,
• Patient who has read and signed the information and consent form
Locations
Other Locations
France
Maison des consultations
RECRUITING
Saran
Time Frame
Start Date: 2020-07-28
Estimated Completion Date: 2031-06-01
Participants
Target number of participants: 50
Treatments
IntraSPINE
The IntraSPINE® implant is a widely used dynamic interlaminar stabilization device that differs from other inter-spinal devices (ISDs) in its structure and its more anterior positioning relative to the spinal axis.~This device is a dimethyl siloxane (silicone) implant covered with a polyethylene terephthalate mesh. Its anterior surface, which comes into contact with the ligamentum flavum (when it is left in place) or with the dura mater, is coated with an anti-adhesive coating.~The device is an elastic support with a cushioning effect. The stiffer anterior portion provides strong distraction, while the more flexible posterior tunnel acts as a stress absorber. The lateral wings secure the device in place, preventing any migration.
Related Therapeutic Areas
Sponsors
Leads: Cousin Biotech