LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant (LISA-PMCF)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain; Degenerative Disc Disease; Herniated Disc; Lumbar Canal Stenosis
• Intervention / Treatment: Device: Lumbar Implant for Stiffness Augmentation (LISA)

• Study Type: Observational
• Enrollment (Anticipated): 136

Contacts and Locations

• Study Contact: Name: Aurélie Affret; Phone Number: 0033686114973; Email: aat@backbone.pro
• Study Contact Backup: Name: Nazanine Sahami; Phone Number: 0033646592539; Email: nsi@backbone.pro

Study Locations

• Denmark
  • Silkeborg, Denmark, 8600
    • Recruiting
    • Elective Surgery Center, Silkeborg Regional Hospital
    • Contact: Aurélie Affret, PhD; Phone Number: 0033686114973; Email: aat@backbone.pro
• France
  • Bordeaux, France, 33300
    • Recruiting
    • Pellegrin University Hospital Center
    • Contact: Aurélie Affret, PhD; Phone Number: 0033686114973; Email: aat@backbone.pro
  • Lyon, France, 69001
    • Recruiting
    • Saint-Charles Clinic
    • Contact: Aurélie Affret, PhD; Phone Number: 0033686114973; Email: aat@backbone.pro
  • Paris, France, 75013
    • Recruiting
    • Pitié-Salpêtrière University Hospital Center
    • Contact: Aurélie Affret, PhD; Phone Number: 003368614973; Email: aat@backbone.pro
• Germany
  • Bad Wildungen, Germany, D-34537
    • Recruiting
    • Asklepios Stadtklinik, Bad Wildungen
    • Contact: Aurélie Affret, PhD; Phone Number: 0033686114973; Email: aat@backbone.pro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Device: Lumbar Implant for Stiffness Augmentation (LISA); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	24-months post surgery; 12-months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LISA implant survival rate defined as successful LISA implantation without reoperation, revision, or removal		3-months post surgery; 6-months post surgery; 48-months post surgery; 72-months post surgery
Duration of the surgery		Perioperative
Duration of the implant placement		Perioperative
Amount of blood loss		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	Perioperative
Number of hospitalization days		3-months post surgery
Time to return to normal activity (working) depending on the patient's profession (blue collar, white collar)		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)		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		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		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.		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.	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.	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.	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.	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"	Pre-operative
Change from baseline in Visual Analogue Scale (VAS) for back pain at 3 months		3-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for back pain at 6 months		6-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for back pain at 12 months		12-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for back pain at 24 months		24-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for back pain at 48 months		48-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for back pain at 72 months		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"	Pre-operative
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 3 months		3-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 6 months		6-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 12 months		12-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 24 months		24-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 48 months		48-months post surgery
Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 72 months		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"	Pre-operative
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 3 months		3-months post-surgery
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 6 months		6-months post-surgery
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 12 months		12-months post-surgery
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 24 months		24-months post-surgery
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 48 months		48-months post-surgery
Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 72 months		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	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	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"	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	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)		Pre-operative
Change from baseline in segmental joints condition at 3-months	Segmental joints condition are assessed thanks to radiological results (if available)	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)	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)	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)	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)	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)	72-months post surgery
Narrowness of the spinal canal assessed thanks to radiological results (if available)		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)	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)	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)	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)	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)	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)	72-months post surgery
Foraminal compression assessed thanks to radiological results (if available)		Pre-operative
Change from baseline in foraminal compression at 3 months	Foraminal compression is assessed thanks to radiological results (if available)	3-months post-surgery
Change from baseline in foraminal compression at 6 months	Foraminal compression is assessed thanks to radiological results (if available)	6-months post-surgery
Change from baseline in foraminal compression at 12 months	Foraminal compression is assessed thanks to radiological results (if available)	12-months post-surgery
Change from baseline in foraminal compression at 24 months	Foraminal compression is assessed thanks to radiological results (if available)	24-months post-surgery
Change from baseline in foraminal compression at 48 months	Foraminal compression is assessed thanks to radiological results (if available)	48-months post-surgery
Change from baseline in foraminal compression at 72 months	Foraminal compression is assessed thanks to radiological results (if available)	72-months post-surgery

Collaborators and Investigators

• Sponsor: BACKBONE
• Investigators: Principal Investigator: Vincent Pointillart, Pellegrin University Hospital Center

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Degenerative Disc Disease; Herniated Disc; Chronic Low-back Pain; Lumbar Canal Stenosis; Dynamic Stabilization Implants; Post-Market Clinical Follow-Up Study
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Back Pain; Low Back Pain; Intervertebral Disc Displacement; Intervertebral Disc Degeneration
• Other Study ID Numbers: DHF-111-PMCF1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No