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

LISA Post Market Clinical Follow-Up Study:Post Marketing Prospective Documentation of Clinical Outcomes (Post-operative, Safety and Performance) After Lumbar Dynamic Stabilization Surgery With LISA Implant

This study looks at how well the LISA implant works and its safety for people who have had surgery for chronic low-back pain.

Quick facts

• Study type: Observational
• Enrollment: 136 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Backbone (Industry-sponsored)
• Locations: 5 sites (Silkeborg and 4 other locations)
• Trial ID: NCT04631133 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are skeletally mature adults aged 18 and older who have chronic low-back pain due to degenerative lesions and have not found relief from conservative treatments.

Not a fit: Patients with advanced degenerative disk lesions, spondylolisthesis, osteoporosis, or other specified exclusions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of the LISA implant, potentially improving treatment options for patients with chronic low-back pain.

How similar studies have performed: Other post-market studies of similar spinal implants have shown promising results, indicating that this approach is supported by prior successful evaluations.

Eligibility criteria

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 this trial is running

Silkeborg and 4 other locations

• 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

Conditions Chronic Low-back Pain; Herniated Disc; Degenerative Disc Disease; Lumbar Canal Stenosis; Dynamic Stabilization Implants; Post-Market Clinical Follow-Up Study