Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04631133

LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Low-back Pain Bone Diseases Degenerative Disc Disease Hernia Herniated Disc Intervertebral Disc Degeneration Intervertebral Disc Displacement Lumbar Canal Stenosis Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Elective Surgery Center, Silkeborg Regional Hospital, Silkeborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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

    Time frame: 24-months post surgery; 12-months post surgery

Secondary outcomes

  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; 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 48 months

    Time frame: 48-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 72 months

    Time frame: 72-months post surgery

    Oswestry Disability Index (ODI) is used to assess limitations of various activities of daily living.

  16. 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"

  17. Change from baseline in Visual Analogue Scale (VAS) for back pain at 3 months

    Time frame: 3-months post surgery

  18. Change from baseline in Visual Analogue Scale (VAS) for back pain at 6 months

    Time frame: 6-months post surgery

  19. Change from baseline in Visual Analogue Scale (VAS) for back pain at 12 months

    Time frame: 12-months post surgery

  20. Change from baseline in Visual Analogue Scale (VAS) for back pain at 24 months

    Time frame: 24-months post surgery

  21. Change from baseline in Visual Analogue Scale (VAS) for back pain at 48 months

    Time frame: 48-months post surgery

  22. Change from baseline in Visual Analogue Scale (VAS) for back pain at 72 months

    Time frame: 72-months post surgery

  23. 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"

  24. Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 3 months

    Time frame: 3-months post surgery

  25. Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 6 months

    Time frame: 6-months post surgery

  26. Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 12 months

    Time frame: 12-months post surgery

  27. Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 24 months

    Time frame: 24-months post surgery

  28. Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 48 months

    Time frame: 48-months post surgery

  29. Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 72 months

    Time frame: 72-months post surgery

  30. 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"

  31. Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 3 months

    Time frame: 3-months post-surgery

  32. Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 6 months

    Time frame: 6-months post-surgery

  33. Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 12 months

    Time frame: 12-months post-surgery

  34. Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 24 months

    Time frame: 24-months post-surgery

  35. Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 48 months

    Time frame: 48-months post-surgery

  36. Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 72 months

    Time frame: 72-months post-surgery

  37. 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

  38. 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

  39. 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"

  40. 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

  41. Segmental joints condition assessed thanks to radiological results (if available)

    Time frame: Pre-operative

  42. 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)

  43. 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)

  44. 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)

  45. 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)

  46. 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)

  47. 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)

  48. Narrowness of the spinal canal assessed thanks to radiological results (if available)

    Time frame: Pre-operative

  49. 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)

  50. 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)

  51. 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)

  52. 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)

  53. 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)

  54. 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)

  55. Foraminal compression assessed thanks to radiological results (if available)

    Time frame: Pre-operative

  56. 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)

  57. 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)

  58. 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)

  59. 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)

  60. 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)

  61. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie Affret

CONTACT

[email protected]

0033686114973

Nazanine Sahami

CONTACT

[email protected]

0033646592539

Sponsors and collaborators

Lead sponsor

BACKBONE

Industry

Registry information

Official study 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

Acronym: LISA-PMCF

Important dates

Study start
2019
Primary completion
2024
Study completion
2028
First posted
Nov 17, 2020
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.