Effectiveness and Safety of the Facet Fixation (FFX®) Implant in the Treatment of Degenerative Lumbar Spinal Stenosis

SC Medica0 sites320 target enrollmentNovember 2023

ConditionsDegenerative Lumbar Spinal Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Lumbar Spinal Stenosis
Sponsor: SC Medica
Enrollment: 320
Primary Endpoint: Proportion of subjects with composite clinical success (CCS)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is a prospective, multicentric, comparative, randomised-controlled study to evaluate the safety and efficacy of the Facet Fixation implant.

The main objective is to evaluate the effectiveness of spinal decompression associated with FFX® implants compared to spinal decompression alone in treating lumbar spinal stenosis after 2 years of treatment.

Registry

clinicaltrials.gov

Start Date

November 2023

End Date

November 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

SC Medica

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 50 years.
•Radiographic confirmation of clinical symptoms of at least moderate degenerative spinal stenosis, of 1 to 3 adjacent segments in the L1-S1 region with the need for surgical decompression.
•Radiographic confirmation of no translational instability in main segment as well as in adjacent segments (dynamic translational instability ≤3 mm);
•Visual analogue scale (VAS) back pain score ≥ 50 mm (on a 100-mm scale).
•Minimum of 3 months of conservative therapy without improvement of symptoms.
•Mental \& physical ability of the subject to follow the protocol (i.e., compliance with time schedule \& treatment plan, able to fill in questionnaire \& to undergo further study procedures).
•Personally signed and dated informed consent document prior to any study-related procedures indicating that the subject has been informed of all pertinent aspects of the clinical investigation.

Exclusion Criteria

•Prior lumbar spine surgery.
•Radiographically confirmed damage of a vertebral body (e.g., osteoporotic compression fracture or because of tumours), at any lumbar level.
•Isthmic or degenerative spondylolisthesis (anterolisthesis; retrolisthesis ≥ grade II) or spondylolysis (pars fracture).
•Degenerative lumbar scoliosis (Cobb angle \> 25°).
•Adipositas (obesity); defined as a body mass index (BMI) \>
•Pregnancy, or wish to get pregnant during the course of the study, or breastfeeding.
•Known allergy or sensitivity to titanium, titanium alloys, or MRI contrast agents.
•Active or chronic infection-systemic or local.
•History of significant peripheral neuropathy.
•Significant peripheral vascular disease (e.g., with diminished dorsalis pedis or posterior tibial pulses).

Outcomes

Primary Outcomes

Proportion of subjects with composite clinical success (CCS)

Time Frame: 2 years

The CCS will be considered as met if ALL of the following criteria are satisfied for a subject: * Back pain score (VAS) decrease by more than 20 mm (on 100-mm scale) * No secondary surgical intervention at the index level (excluding wound problems) * No non-surgical lumbar treatment of interest at any lumbar level