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LISA Post Market Clinical Follow-Up Study: Post Marketing Prospective Documentation of Clinical Outcomes After Lumbar Dynamic Stabilization Surgery With LISA Implant
Led by BACKBONE · Updated on 2022-07-21
136
Participants Needed
5
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Lumbar Implant for Stiffness Augmentation (LISA), a medical device designed to treat low-back pain caused by degenerative lesions classified as grades II, III, and IV by Pfirrmann MRI. This post-market surveillance study aims to assess the long-term safety and performance of the LISA implant, which has already received CE certification and is used commercially in Europe. The study is sponsored by BACKBONE, the device's developer and manufacturer. The LISA implant consists of three parts: a PEEK interspinous spacer placed between two adjacent spinous processes, a polyester band wrapped around the spinous processes and through the spacer, and a titanium blocker that locks the band inside the spacer. The study observes patients who undergo lumbar dynamic stabilization surgery using the LISA implant. It documents surgical details such as surgery duration, blood loss, and hospitalization time. Follow-ups occur at multiple points up to 72 months after surgery to monitor implant survival, complications, and patient outcomes. Participants will be assessed before surgery and at various intervals after surgery, including 3, 6, 12, 24, 48, and 72 months. Evaluations include clinical questionnaires like the Oswestry Disability Index and Visual Analogue Scale for back and leg pain, radiological assessments of the spine, and monitoring for device-related complications or reoperations. Researchers will track patient satisfaction and surgeon assessments while collecting data on recovery times and the implant's long-term performance. The study continues until December 2028 to gather comprehensive safety and effectiveness information.
CONDITIONS
Brief Title
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Skeletally mature patients aged 18 years or older
- Low-back pain caused by degenerative lesions of grade II, III, or IV (Pfirrmann MRI classification)
- Failed conservative treatment for low back pain for at least 6 months
You will not qualify if you...
- 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 compromising surgical goals
- Major local inflammatory phenomena
- Pregnant or lactating women
- Immunosuppressive diseases
- Bone immaturity
- Severe mental illnesses
- Bone metabolism diseases affecting implant support
- Patients with worker's compensation, litigation, or disability benefits
- Excessive physical activities
- Patients deprived of liberty under national regulations
- Protected patients or those unable to consent under national regulations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Perioperative period
Participants undergo lumbar dynamic stabilization surgery with the LISA implant and receive immediate post-operative care including assessments of surgical technique, blood loss, and hospitalization.
1 surgical visit and immediate post-operative assessments
Duration - Up to 72 months post surgery
Participants are monitored for clinical outcomes including implant survival, pain levels, disability, radiological changes, complications, and patient satisfaction over several years after surgery.
Regular follow-up visits at 3, 6, 12, 24, 48, and 72 months post surgery
Trial Site Locations
Total: 5 locations
1
Elective Surgery Center, Silkeborg Regional Hospital
Silkeborg, Denmark, 8600
Actively Recruiting
2
Pellegrin University Hospital Center
Bordeaux, France, 33300
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3
Saint-Charles Clinic
Lyon, France, 69001
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4
Pitié-Salpêtrière University Hospital Center
Paris, France, 75013
Actively Recruiting
5
Asklepios Stadtklinik, Bad Wildungen
Bad Wildungen, Germany, D-34537
Actively Recruiting
Research Team
A
Aurélie Affret
N
Nazanine Sahami
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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