Long-Term safety and performance of the IntraSPINE interlaminar implant for degenerative lumbar spine disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational extension study tracking patients who had the IntraSPINE implant for degenerative lumbar spine conditions. It recontacts about 50 participants from an earlier trial (2012–2017) to collect long-term clinical and radiological data, including MRI findings. The goal is to understand long-term safety and performance of the implant in real-world follow-up. Participants are adults who had one or two lumbar levels treated after conservative care failed, with assessment ongoing at least 9 years post-implant. The study design does not assign treatment randomized groups and focuses on extended observation.

Why it matters

Who can join: the full rules

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

Where it's running

• Maison des consultations
  Saran, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.