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

NCT04631133 | Recruiting

• 1 other identifier: DHF-111-PMCF1
• Study Type: observational
• Target: 136
• Locations: 3 countries
• Sites: 5

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 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.

Conditions

Chronic Low-back Pain; Herniated Disc; Degenerative Disc Disease; Lumbar Canal Stenosis

Keywords

Chronic Low-back Pain; Herniated Disc; Degenerative Disc Disease; Lumbar Canal Stenosis; Dynamic Stabilization Implants; Post-Market Clinical Follow-Up Study

Outcome Measures

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

  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

  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

  Perioperative

Study Arms (1)

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)

Interventions

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).

Participants with low-back pain and degenerative lesions of grade II, III, IV (Pfirrmann MRI class)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BACKBONE: lead

Study Sites (5)

Elective Surgery Center, Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

RECRUITING

Pellegrin University Hospital Center

Bordeaux, 33300, France

RECRUITING

Saint-Charles Clinic

Lyon, 69001, France

RECRUITING

Pitié-Salpêtrière University Hospital Center

Paris, 75013, France

RECRUITING

Asklepios Stadtklinik, Bad Wildungen

Bad Wildungen, D-34537, Germany

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Vincent Pointillart

  Pellegrin University Hospital Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélie Affret

CONTACT

0033686114973; aat@backbone.pro

Nazanine Sahami

CONTACT

0033646592539; nsi@backbone.pro

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 17, 2020
• Study Start: April 17, 2019
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

FR (3); DK (1); DE (1)