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

Recruitingn/aAges 18 Years - anyAllCousin Biotech
NCT07790328 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • IntraSPINE
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Where

1 site
Maison des consultations
Saran, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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