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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04631133
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
BACKBONE

Brief 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 lumbar stenosis and chronic back pain due to lumbar degenerative disease, and restore the natural movements of the spine. "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 implant consists of a "spacer", a woven polyester band and a titanium blocker. The spacer is placed between the two vertebrae, identified causing back pain and is fastened by the band to these vertebrae. The band is tightened and locked into the spacer. This ensures that there is sufficient stiffness at the concerned segment to protect the disc from extra stress and to restore natural mobility.

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.


Condition or disease Intervention/treatment
Chronic Low-back Pain Herniated Disc Degenerative Disc Disease Lumbar Canal Stenosis Device: Lumbar Implant for Stiffness Augmentation (LISA)

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Study Type : Observational
Estimated Enrollment : 129 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort Intervention/treatment
Participants with low-back pain and degenerative lesions of grade II, III, IV (Pfirmann MRI class.)

Participants with low-back pain that accompanies degenerative lesions of grade II, III and IV (Pfirrmann MRI classification) in the following indications:

  • Massive herniated disc in young adults
  • Recurrent herniated disc or herniated disc accompanying an L5 sacralization transitional anomaly, treated by discectomy
  • Degenerative disc disease at a segment adjacent to a fusion
  • Degenerative lesions with or without Modic 1
  • Lumbar canal stenosis treated by partial laminotomy
Device: Lumbar Implant for Stiffness Augmentation (LISA)
The Lumbar Implant for Stiffness Augmentation (LISA) is intended to limit the lumbar lordotic movement thanks to a rigid spacer inserted between two adjacent spinous processes and to limit the kyphotic movement with an artificial ligament encircling the two adjacent spinous processes.




Primary Outcome Measures :
  1. LISA implant survival rate two years after surgery defined as successful LISA implantation without reoperation, revision, or removal [ Time Frame: 24-months post surgery ]

Secondary Outcome Measures :
  1. LISA implant survival rate defined as successful LISA implantation without reoperation, revision, or removal [ Time Frame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 48-months post surgery; 72-months post surgery ]
  2. Duration of the surgery [ Time Frame: Perioperative ]
  3. Duration of the implant placement [ Time Frame: Perioperative ]
  4. Amount of blood loss [ Time Frame: Perioperative ]
  5. Scoring of the surgical technique assessed by a 14-items question [ Time Frame: Perioperative ]
    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

  6. Number of hospitalization days [ Time Frame: 3-months post surgery ]
  7. Time to return to normal activity (working) depending on the patient's profession (blue collar, white collar) [ Time Frame: 3-months post surgery ]
  8. 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) [ Time Frame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery ]
  9. 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 [ Time Frame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery ]
  10. 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 [ Time Frame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery ]
  11. Oswestry Disability Index (ODI) to assess limitations of various activities of daily living. [ Time Frame: Pre-operative ]
  12. Change from baseline in Oswestry Disability Index at 3 months [ Time Frame: 3-months post surgery ]
    Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.

  13. Change from baseline in Oswestry Disability Index at 6 months [ Time Frame: 6-months post surgery ]
    Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.

  14. Change from baseline in Oswestry Disability Index at 12 months [ Time Frame: 12-months post surgery ]
    Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.

  15. Change from baseline in Oswestry Disability Index at 24 months [ Time Frame: 24-months post surgery ]
    Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.

  16. Change from baseline in Oswestry Disability Index at 48 months [ Time Frame: 48-months post surgery ]
    Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.

  17. Change from baseline in Oswestry Disability Index at 72 months [ Time Frame: 72-months post surgery ]
    Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.

  18. Visual Analogue Scale (VAS) to assess back pain [ Time Frame: Pre-operative ]
    Patients rate their back pain from 0 to 10, "0" meaning "No pain at all" and "10" meaning "the worst pain ever possible"

  19. Change from baseline in Visual Analogue Scale (VAS) for back pain at 3 months [ Time Frame: 3-months post surgery ]
  20. Change from baseline in Visual Analogue Scale (VAS) for back pain at 6 months [ Time Frame: 6-months post surgery ]
  21. Change from baseline in Visual Analogue Scale (VAS) for back pain at 12 months [ Time Frame: 12-months post surgery ]
  22. Change from baseline in Visual Analogue Scale (VAS) for back pain at 24 months [ Time Frame: 24-months post surgery ]
  23. Change from baseline in Visual Analogue Scale (VAS) for back pain at 48 months [ Time Frame: 48-months post surgery ]
  24. Change from baseline in Visual Analogue Scale (VAS) for back pain at 72 months [ Time Frame: 72-months post surgery ]
  25. Visual Analogue Scale (VAS) to assess right leg pain [ Time Frame: Pre-operative ]
    Patients rate their right leg pain from 0 to 10, "0" meaning "No pain at all" and "10" meaning "the worst pain ever possible"

  26. Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 3 months [ Time Frame: 3-months post surgery ]
  27. Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 6 months [ Time Frame: 6-months post surgery ]
  28. Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 12 months [ Time Frame: 12-months post surgery ]
  29. Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 24 months [ Time Frame: 24-months post surgery ]
  30. Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 48 months [ Time Frame: 48-months post surgery ]
  31. Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 72 months [ Time Frame: 72-months post surgery ]
  32. Visual Analogue Scale (VAS) to assess left leg pain [ Time Frame: Pre-operative ]
    Patients rate their left leg pain from 0 to 10, "0" meaning "No pain at all" and "10" meaning "the worst pain ever possible"

  33. Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 3 months [ Time Frame: 3-months post-surgery ]
  34. Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 6 months [ Time Frame: 6-months post-surgery ]
  35. Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 12 months [ Time Frame: 12-months post-surgery ]
  36. Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 24 months [ Time Frame: 24-months post-surgery ]
  37. Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 48 months [ Time Frame: 48-months post-surgery ]
  38. Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 72 months [ Time Frame: 72-months post-surgery ]
  39. Patient satisfaction with treatment assessed by a 4-items question [ Time Frame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery ]
    Patients rate their satisfaction with treatment choosing one of the following options: Very satisfied/Somewhat satisfied/Somewhat dissatisfied/Very Dissatisfied

  40. Patient's recommendation for treatment assessed by a 4-items question [ Time Frame: 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 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

  41. Patient's opinion related to the treatment assessed by a 6-items question [ Time Frame: 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 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"

  42. Surgeon surgery outcome assessed by a 4-items question [ Time Frame: 3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery ]
    Surgeons rate the result of the surgery, choosing one of the following options: Excellent; Good; Fair; Poor

  43. Segmental joints condition assessed thanks to radiological results (if available) [ Time Frame: Pre-operative ]
  44. Change from baseline in segmental joints condition at 3-months [ Time Frame: 3-months post surgery ]
    Segmental joints condition are assessed thanks to radiological results (if available)

  45. Change from baseline in segmental joints condition at 6-months [ Time Frame: 6-months post surgery ]
    Segmental joints condition are assessed thanks to radiological results (if available)

  46. Change from baseline in segmental joints condition at 12-months [ Time Frame: 12-months post surgery ]
    Segmental joints condition are assessed thanks to radiological results (if available)

  47. Change from baseline in segmental joints condition at 24-months [ Time Frame: 24-months post surgery ]
    Segmental joints condition are assessed thanks to radiological results (if available)

  48. Change from baseline in segmental joints condition at 48-months [ Time Frame: 48-months post surgery ]
    Segmental joints condition are assessed thanks to radiological results (if available)

  49. Change from baseline in segmental joints condition at 72-months [ Time Frame: 72-months post surgery ]
    Segmental joints condition are assessed thanks to radiological results (if available)

  50. Narrowness of the spinal canal assessed thanks to radiological results (if available) [ Time Frame: Pre-operative ]
  51. Change from baseline in narrowness of the spinal canal at 3 months [ Time Frame: 3-months post surgery ]
    Narrowness of the spinal canal is assessed thanks to radiological results (if available)

  52. Change from baseline in narrowness of the spinal canal at 6 months [ Time Frame: 6-months post surgery ]
    Narrowness of the spinal canal is assessed thanks to radiological results (if available)

  53. Change from baseline in narrowness of the spinal canal at 12 months [ Time Frame: 12-months post surgery ]
    Narrowness of the spinal canal is assessed thanks to radiological results (if available)

  54. Change from baseline in narrowness of the spinal canal at 24 months [ Time Frame: 24-months post surgery ]
    Narrowness of the spinal canal is assessed thanks to radiological results (if available)

  55. Change from baseline in narrowness of the spinal canal at 48 months [ Time Frame: 48-months post surgery ]
    Narrowness of the spinal canal is assessed thanks to radiological results (if available)

  56. Change from baseline in narrowness of the spinal canal at 72 months [ Time Frame: 72-months post surgery ]
    Narrowness of the spinal canal is assessed thanks to radiological results (if available)

  57. Foraminal compression assessed thanks to radiological results (if available) [ Time Frame: Pre-operative ]
  58. Change from baseline in foraminal compression at 3 months [ Time Frame: 3-months post-surgery ]
    Foraminal compression is assessed thanks to radiological results (if available)

  59. Change from baseline in foraminal compression at 6 months [ Time Frame: 6-months post-surgery ]
    Foraminal compression is assessed thanks to radiological results (if available)

  60. Change from baseline in foraminal compression at 12 months [ Time Frame: 12-months post-surgery ]
    Foraminal compression is assessed thanks to radiological results (if available)

  61. Change from baseline in foraminal compression at 24 months [ Time Frame: 24-months post-surgery ]
    Foraminal compression is assessed thanks to radiological results (if available)

  62. Change from baseline in foraminal compression at 48 months [ Time Frame: 48-months post-surgery ]
    Foraminal compression is assessed thanks to radiological results (if available)

  63. Change from baseline in foraminal compression at 72 months [ Time Frame: 72-months post-surgery ]
    Foraminal compression is assessed thanks to radiological results (if available)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants must meet all inclusion criteria, have at least one of the indications 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) in the following indications:

  • Massive herniated disc in young adults
  • Recurrent herniated disc or herniated disc accompanying an L5 sacralization transitional anomaly, treated by discectomy
  • Degenerative disc disease at a segment adjacent to a fusion
  • Degenerative lesions with or without Modic 1
  • Lumbar canal stenosis treated by partial laminotomy
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
  • Having at least one of the indications for LISA implant surgery

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 article L 1121-6 of the French code of the public health or respective national regulations
  • Protected patients or patients not in a position to declare his or her consent in accordance with article L 1121-8 of the French code of the public health or respective national regulations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04631133


Contacts
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Contact: Aurélie Affret 0033686114973 aat@backbone.pro
Contact: Nazanine Sahami 0033646592539 nsi@backbone.pro

Locations
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Denmark
Elective Surgery Center, Silkeborg Regional Hospital Not yet recruiting
Silkeborg, Denmark, 8600
Contact: Aurélie Affret, PhD    0033686114973    aat@backbone.pro   
France
Pellegrin University Hospital Center Recruiting
Bordeaux, France, 33300
Contact: Aurélie Affret, PhD    0033686114973    aat@backbone.pro   
Saint-Charles Clinic Not yet recruiting
Lyon, France, 69001
Contact: Aurélie Affret, PhD    0033686114973    aat@backbone.pro   
Pitié-Salpêtrière University Hospital Center Not yet recruiting
Paris, France, 75013
Contact: Aurélie Affret, PhD    003368614973    aat@backbone.pro   
Germany
Asklepios Stadtklinik, Bad Wildungen Not yet recruiting
Bad Wildungen, Germany, D-34537
Contact: Aurélie Affret, PhD    0033686114973    aat@backbone.pro   
Sponsors and Collaborators
BACKBONE
Investigators
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Principal Investigator: Vincent Pointillart Pellegrin University Hospital Center
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Responsible Party: BACKBONE
ClinicalTrials.gov Identifier: NCT04631133    
Other Study ID Numbers: DHF-111-PMCF1
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BACKBONE:
Chronic Low-back Pain
Herniated Disc
Degenerative Disc Disease
Lumbar Canal Stenosis
Dynamic Stabilization Implants
Post-Market Clinical Follow-Up Study
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Intervertebral Disc Displacement
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia