Chronic Low-back PainLISA-PMCFNCT04631133
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
An observational study of Chronic Low-back Pain and Herniated Disc, run by BACKBONE at 5 sites in 3 countries.
Trial summary
The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV (Pfirrmann MRI classification). "Post-market" means the device (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease
- What is being tested?
- Lumbar Implant for Stiffness Augmentation (LISA)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 136 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 17 Apr 2019to 31 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants must meet all inclusion criteria, and none of the exclusion criteria as described in the instructions for use of the LISA implant. The Lumbar Implant for Stiffness Augmentation, LISA, treats low-back pain that accompanies degenerative lesions of grade II, III and IV (Pfirrmann MRI classification).
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
France3 sites, 3 recruiting
- Recruiting
Pellegrin University Hospital Center
Bordeaux, 33300
Aurélie Affret, PhD, 0033686114973, aat@backbone.pro
- Recruiting
Saint-Charles Clinic
Lyon, 69001
Aurélie Affret, PhD, 0033686114973, aat@backbone.pro
- Recruiting
Pitié-Salpêtrière University Hospital Center
Paris, 75013
Aurélie Affret, PhD, 003368614973, aat@backbone.pro
Denmark1 site, 1 recruiting
- Recruiting
Elective Surgery Center, Silkeborg Regional Hospital
Silkeborg, 8600
Aurélie Affret, PhD, 0033686114973, aat@backbone.pro
Germany1 site, 1 recruiting
- Recruiting
Asklepios Stadtklinik, Bad Wildungen
Bad Wildungen, D-34537
Aurélie Affret, PhD, 0033686114973, aat@backbone.pro
About this study
Official title: 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
The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV (Pfirrmann MRI classification). "Post-market" means the device (i.e. the LISA implant) being used in this study has already obtained CE certification and is commercially available for use in the European market.
The LISA device consists of 3 components: A PEEK interspinous spacer, a polyester band, and a titanium blocker. The spacer is positioned between two adjacent spinous processes, the band is belted around the spinous processes and through the spacer, and the blocker is used to lock the band inside the spacer.
Read more
Medical Device manufacturers conduct "post-market" clinical studies in order to continuously evaluate the product scientifically and to comply with legal and ethical obligations. With these studies, the long-term safety as well as performance of their medical devices are assessed.
This study, which is initiated and sponsored by BACKBONE (LISA designer, developer, manufacturer and marketer), aims to evaluate the long-term safety and performance of the LISA implant for the treatment of lumbar degenerative disease and to evaluate the treatment.
- Being tested
- Lumbar Implant for Stiffness Augmentation (LISA)
- Keywords
- Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease, Lumbar Canal Stenosis, Dynamic Stabilization Implants, Post-Market Clinical Follow-Up Study
- Medical subject headings
- Intervertebral Disc Displacement, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Implant for Stiffness Augmentation (LISA)Device
The LISA Posterior Dynamic Stabilization System is intended to treat low-back pain that accompanies degenerative lesions of grade II, III and IV (Pfirrmann MRI classification).
| Study group | Role | What they receive |
|---|---|---|
| Participants with low-back pain and degenerative lesions of grade II, III, IV (Pfirrmann MRI class) | Participants with low-back pain that accompanies degenerative lesions of grade II, III and IV (Pfirrmann MRI classification) Receives: Device: Lumbar Implant for Stiffness Augmentation (LISA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
LISA implant survival rate 2 years after surgery defined as successful LISA implantation without reoperation, revision, or removal/ ODI change between pre-operative assessment and 2 years follow-up (FU)/ 1ary endpoint will also be evaluated at 1-year FU
Measured: 24-months post surgery; 12-months post surgery
Secondary outcomes (61)
LISA implant survival rate defined as successful LISA implantation without reoperation, revision, or removal
Measured: 3-months post surgery; 6-months post surgery; 48-months post surgery; 72-months post surgery
Duration of the surgery
Measured: Perioperative
Duration of the implant placement
Measured: Perioperative
Amount of blood loss
Measured: Perioperative
Scoring of the surgical technique assessed by a 14-items question
14 steps of the surgical technique are rated from 0 to 7; 0 being considered as very easy and 7 being considered as very difficult
Measured: Perioperative
Number of hospitalization days
Measured: 3-months post surgery
Time to return to normal activity (working) depending on the patient's profession (blue collar, white collar)
Measured: 3-months post surgery
Number of patients with reoperations/ revision or removal at the operative level or on adjacent levels relating to the device and not the pathology/ implant breakage (polyester band rupture)
Measured: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
Number of patients with migration or rupture of any implant component (Polyester band loose)/ major unanticipated device related complications/ post-operative scapular pain/ recurrence of the initial symptoms/ degeneration of the adjacent segments
Measured: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
Number of patients with superficial infection/ dural injury/ bone fracture or bone erosion anywhere implant is in contact with the anatomy/ Any other procedure or device related adverse events
Measured: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
Oswestry Disability Index (ODI) to assess limitations of various activities of daily living.
Measured: Pre-operative
Change from baseline in Oswestry Disability Index at 3 months
Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.
Measured: 3-months post surgery
Change from baseline in Oswestry Disability Index at 6 months
Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.
Measured: 6-months post surgery
Change from baseline in Oswestry Disability Index at 48 months
Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.
Measured: 48-months post surgery
Change from baseline in Oswestry Disability Index at 72 months
Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.
Measured: 72-months post surgery
Visual Analogue Scale (VAS) to assess back pain
Patients rate their back pain from 0 to 10, "0" meaning "No pain at all" and "10" meaning "the worst pain ever possible"
Measured: Pre-operative
Change from baseline in Visual Analogue Scale (VAS) for back pain at 3 months
Measured: 3-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for back pain at 6 months
Measured: 6-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for back pain at 12 months
Measured: 12-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for back pain at 24 months
Measured: 24-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for back pain at 48 months
Measured: 48-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for back pain at 72 months
Measured: 72-months post surgery
Visual Analogue Scale (VAS) to assess right leg pain
Patients rate their right leg pain from 0 to 10, "0" meaning "No pain at all" and "10" meaning "the worst pain ever possible"
Measured: Pre-operative
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 3 months
Measured: 3-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 6 months
Measured: 6-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 12 months
Measured: 12-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 24 months
Measured: 24-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 48 months
Measured: 48-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 72 months
Measured: 72-months post surgery
Visual Analogue Scale (VAS) to assess left leg pain
Patients rate their left leg pain from 0 to 10, "0" meaning "No pain at all" and "10" meaning "the worst pain ever possible"
Measured: Pre-operative
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 3 months
Measured: 3-months post-surgery
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 6 months
Measured: 6-months post-surgery
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 12 months
Measured: 12-months post-surgery
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 24 months
Measured: 24-months post-surgery
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 48 months
Measured: 48-months post-surgery
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 72 months
Measured: 72-months post-surgery
Patient satisfaction with treatment assessed by a 4-items question
Patients rate their satisfaction with treatment choosing one of the following options: Very satisfied/Somewhat satisfied/Somewhat dissatisfied/Very Dissatisfied
Measured: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
Patient's recommendation for treatment assessed by a 4-items question
Patient rate wether they would recommend the same treatment to a friend with the same condition, choosing one of the following options: Definitely YES/Probably YES/ Probably NO/ Definitely NOT
Measured: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
Patient's opinion related to the treatment assessed by a 6-items question
Patient rate how effective was the treatment in eliminating the symptoms choosing one of the following options: "very effective, relieved all the symptoms", "moderately effective", "somewhat effective", "somewhat ineffective", "moderately ineffective", "very ineffective, did not relieve or lessen the symptoms"
Measured: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
Surgeon surgery outcome assessed by a 4-items question
Surgeons rate the result of the surgery, choosing one of the following options: Excellent; Good; Fair; Poor
Measured: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery
Segmental joints condition assessed thanks to radiological results (if available)
Measured: Pre-operative
Change from baseline in segmental joints condition at 3-months
Segmental joints condition are assessed thanks to radiological results (if available)
Measured: 3-months post surgery
Change from baseline in segmental joints condition at 6-months
Segmental joints condition are assessed thanks to radiological results (if available)
Measured: 6-months post surgery
Change from baseline in segmental joints condition at 12-months
Segmental joints condition are assessed thanks to radiological results (if available)
Measured: 12-months post surgery
Change from baseline in segmental joints condition at 24-months
Segmental joints condition are assessed thanks to radiological results (if available)
Measured: 24-months post surgery
Change from baseline in segmental joints condition at 48-months
Segmental joints condition are assessed thanks to radiological results (if available)
Measured: 48-months post surgery
Change from baseline in segmental joints condition at 72-months
Segmental joints condition are assessed thanks to radiological results (if available)
Measured: 72-months post surgery
Narrowness of the spinal canal assessed thanks to radiological results (if available)
Measured: Pre-operative
Change from baseline in narrowness of the spinal canal at 3 months
Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Measured: 3-months post surgery
Change from baseline in narrowness of the spinal canal at 6 months
Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Measured: 6-months post surgery
Change from baseline in narrowness of the spinal canal at 12 months
Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Measured: 12-months post surgery
Change from baseline in narrowness of the spinal canal at 24 months
Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Measured: 24-months post surgery
Change from baseline in narrowness of the spinal canal at 48 months
Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Measured: 48-months post surgery
Change from baseline in narrowness of the spinal canal at 72 months
Narrowness of the spinal canal is assessed thanks to radiological results (if available)
Measured: 72-months post surgery
Foraminal compression assessed thanks to radiological results (if available)
Measured: Pre-operative
Change from baseline in foraminal compression at 3 months
Foraminal compression is assessed thanks to radiological results (if available)
Measured: 3-months post-surgery
Change from baseline in foraminal compression at 6 months
Foraminal compression is assessed thanks to radiological results (if available)
Measured: 6-months post-surgery
Change from baseline in foraminal compression at 12 months
Foraminal compression is assessed thanks to radiological results (if available)
Measured: 12-months post-surgery
Change from baseline in foraminal compression at 24 months
Foraminal compression is assessed thanks to radiological results (if available)
Measured: 24-months post-surgery
Change from baseline in foraminal compression at 48 months
Foraminal compression is assessed thanks to radiological results (if available)
Measured: 48-months post-surgery
Change from baseline in foraminal compression at 72 months
Foraminal compression is assessed thanks to radiological results (if available)
Measured: 72-months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start17 Apr 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BACKBONE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincent Pointillart, Principal investigator, Pellegrin University Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631133
- Sponsor's protocol ID
- DHF-111-PMCF1
- Acronym
- LISA-PMCF
- Status last verified
- Jul 2022
- First submitted
- 2 Nov 2020
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No