Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in France / NCT07790328
Recruiting Observational

Long-Term Evaluation of the Performance and Safety of the IntraSPINE® Interlaminar Implant in the Treatment of Lumbar Degenerative Disc Disease

NCT07790328 · tracked via the Priya Life Science France tracker
Sponsor
Cousin Biotech
Phase
Observational
Started
2020-07-28
Last updated
2026-08-27

Condition(s) studied

Lower Back Pain of Disc OriginJoint Facet SyndromeLumbar Canal StenosisSpinal Disease

Investigational drug(s) / intervention(s)

IntraSPINE

IntraSPINE: Intraspine is an interlaminar device not interspinous.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with the following contraindications: * Allergy to any of the components, * Infected site, * Pregnant women. * Patients with spondylolisthesis with isthmic lysis

Primary outcome measure(s)

  • Clinical success rate at long term (at least 9 years) — At least 9 years after enrollment in the pivotal study
    The clinical success is defined by : * An improvement (decrease) in the ODI score of at least 30% compared to the score at enrollment in the pivotal study * No complications such as revision, reoperation, implant removal, infection, or any other adverse events related to the surgery or the device since enrollment in the pivotal study

Trial sites (1)

FacilityCityRegionStatus
Maison des consultations Saran France Recruiting

More Cousin Biotech trials in France

Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap) Active, not recruiting

Other trials for the same condition

LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07790328 on ClinicalTrials.gov ↗ ← All trials in France