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

Degenerative Disc Disease Clinical Trial

— LISA-PMCF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04631133
• Other study ID #: DHF-111-PMCF1
• Status: Recruiting
• Start date: April 17, 2019
• Est. completion date: December 31, 2028

Study information

• Verified date: July 2022
• Source: BACKBONE
• Contact: Aurélie Affret
• Phone: 0033686114973
• Email: aat[@]backbone.pro
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Degenerative Disc Disease
• Herniated Disc
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Low Back Pain
• Lumbar Canal Stenosis

Intervention

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).

Locations

Country	Name	City	State
Denmark	Elective Surgery Center, Silkeborg Regional Hospital	Silkeborg
France	Pellegrin University Hospital Center	Bordeaux
France	Saint-Charles Clinic	Lyon
France	Pitié-Salpêtrière University Hospital Center	Paris
Germany	Asklepios Stadtklinik, Bad Wildungen	Bad Wildungen

Sponsors (1)

Lead Sponsor	Collaborator
BACKBONE

Countries where clinical trial is conducted

Denmark,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Duration of the surgery		Perioperative
Secondary	Duration of the implant placement		Perioperative
Secondary	Amount of blood loss		Perioperative
Secondary	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
Secondary	Number of hospitalization days		3-months post surgery
Secondary	Time to return to normal activity (working) depending on the patient's profession (blue collar, white collar)		3-months post surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Oswestry Disability Index (ODI) to assess limitations of various activities of daily living.		Pre-operative
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline in Visual Analogue Scale (VAS) for back pain at 3 months		3-months post surgery
Secondary	Change from baseline in Visual Analogue Scale (VAS) for back pain at 6 months		6-months post surgery
Secondary	Change from baseline in Visual Analogue Scale (VAS) for back pain at 12 months		12-months post surgery
Secondary	Change from baseline in Visual Analogue Scale (VAS) for back pain at 24 months		24-months post surgery
Secondary	Change from baseline in Visual Analogue Scale (VAS) for back pain at 48 months		48-months post surgery
Secondary	Change from baseline in Visual Analogue Scale (VAS) for back pain at 72 months		72-months post surgery
Secondary	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
Secondary	Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 3 months		3-months post surgery
Secondary	Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 6 months		6-months post surgery
Secondary	Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 12 months		12-months post surgery
Secondary	Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 24 months		24-months post surgery
Secondary	Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 48 months		48-months post surgery
Secondary	Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 72 months		72-months post surgery
Secondary	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
Secondary	Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 3 months		3-months post-surgery
Secondary	Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 6 months		6-months post-surgery
Secondary	Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 12 months		12-months post-surgery
Secondary	Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 24 months		24-months post-surgery
Secondary	Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 48 months		48-months post-surgery
Secondary	Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 72 months		72-months post-surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Segmental joints condition assessed thanks to radiological results (if available)		Pre-operative
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Narrowness of the spinal canal assessed thanks to radiological results (if available)		Pre-operative
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Foraminal compression assessed thanks to radiological results (if available)		Pre-operative
Secondary	Change from baseline in foraminal compression at 3 months	Foraminal compression is assessed thanks to radiological results (if available)	3-months post-surgery
Secondary	Change from baseline in foraminal compression at 6 months	Foraminal compression is assessed thanks to radiological results (if available)	6-months post-surgery
Secondary	Change from baseline in foraminal compression at 12 months	Foraminal compression is assessed thanks to radiological results (if available)	12-months post-surgery
Secondary	Change from baseline in foraminal compression at 24 months	Foraminal compression is assessed thanks to radiological results (if available)	24-months post-surgery
Secondary	Change from baseline in foraminal compression at 48 months	Foraminal compression is assessed thanks to radiological results (if available)	48-months post-surgery
Secondary	Change from baseline in foraminal compression at 72 months	Foraminal compression is assessed thanks to radiological results (if available)	72-months post-surgery