LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBACKBONE
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Stage V degenerative disk lesions in Pfirrmann's MRI classification
Spondylolisthesis
Osteoporosis
Non-specific back pain
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Lumbar Implant for Stiffness Augmentation (LISA)
DeviceThe 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).
Treatment groups
136 Participants
are divided into 1 treatment groupGroup A: Participants with low-back pain and degenerative lesions of grade II, III, IV (Pfirrmann MRI class)1 intervention
Trial outcomes
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 surgerySecondary 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 surgery2
Duration of the surgery
Time frame
Perioperative3
Duration of the implant placement
Time frame
Perioperative4
Amount of blood loss
Time frame
Perioperative Source ClinicalTrials.gov