Long-Term Evaluation of the Performance and Safety of the IntraSPINE® Interlaminar Implant in the Treatment of Lumbar Degenerative Disc Disease
NCT07790328 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50
Last updated 2026-08-27
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.
Conditions
- Lower Back Pain of Disc Origin
- Joint Facet Syndrome
- Lumbar Canal Stenosis
- Spinal Disease
Interventions
- DRUG
-
IntraSPINE
Intraspine is an interlaminar device not interspinous.
Sponsors & Collaborators
-
Cousin Biotech
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-28
- Primary Completion
- 2026-06-01
- Completion
- 2031-06-01
Countries
- France
Study Locations
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