Follow-up on outcomes after surgery with the LISA implant for back pain

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 observational study monitors the clinical outcomes of patients who have undergone surgery using the Lumbar Implant for Stiffness Augmentation (LISA) to treat chronic low-back pain associated with degenerative lesions. The LISA device, which has already received CE certification, consists of a PEEK interspinous spacer, a polyester band, and a titanium blocker, designed to stabilize the spine. The study aims to evaluate the long-term safety and performance of the LISA implant in a real-world setting following its market introduction.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Skeletally mature patients Patient ≥18 years of age
* Patients with low-back pain caused by degenerative lesions of grade II, III and IV (Pfirrmann MRI classification)
* Failed conservative treatment for low back pain conducted for at least 6 months

Exclusion Criteria:

* Stage V degenerative disk lesions in Pfirrmann's MRI classification
* Spondylolisthesis
* Osteoporosis
* Non-specific back pain
* Modic 2 and Modic 3 changes
* L5/S1 segments affected
* Local or general infections that may compromise the surgical goals
* Major local inflammatory phenomena
* Pregnant and lactating Women
* Immunosuppressive diseases
* Bone immaturity
* Severe mental illnesses
* Bone metabolism diseases that may compromise the mechanical support expected from this type of implant
* Patient with worker's compensation, under litigation or on disability benefits
* Excessive physical activities
* Patients deprived of their liberty in accordance with respective national regulations
* Protected patients or patients not in a position to declare his or her consent in accordance with respective national regulations

Where it's running

• Elective Surgery Center, Silkeborg Regional Hospital
  Silkeborg, Denmark Recruiting
• Pellegrin University Hospital Center
  Bordeaux, France Recruiting
• Saint-Charles Clinic
  Lyon, France Recruiting
• Pitié-Salpêtrière University Hospital Center
  Paris, France Recruiting
• Asklepios Stadtklinik, Bad Wildungen
  Bad Wildungen, Germany Recruiting

Study contacts

• Principal investigator: Vincent Pointillart — Pellegrin University Hospital Center
• Study coordinator: Aurélie Affret
• Email: aat@backbone.pro
• Phone: 0033686114973

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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.