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

NCT06106061 | Not Yet Recruiting

• 1 other identifier: 2023-A01382-43
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Degenerative Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with composite clinical success (CCS)

  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

  2 years

Study Arms (2)

Group one: Decompression + FFX®

EXPERIMENTAL

Device: Decompression + FFX®

Group two: Decompression alone

ACTIVE COMPARATOR

Procedure: Decompression alone

Interventions

Decompression + FFX® DEVICE

Surgical treatment of degenerative lumbar spinal stenosis by spinal decompression associated with the use of FFX® implant

Group one: Decompression + FFX®

Decompression alone PROCEDURE

Surgical treatment of degenerative lumbar spinal stenosis by spinal decompression alone

Group two: Decompression alone

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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) \>40.
• 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).
• Paget disease, osteomalacia or other metabolic bone disorders.
• Cauda equina syndrome.
• Known or documented history of transmissible disease, including AIDS, HIV and active hepatitis.
• More than 3 vertebral levels requiring surgery.
• Disc herniation at any lumbar level requiring surgical intervention.

Sponsors & Collaborators

• SC Medica: lead

MeSH Terms

Interventions

Decompression

Intervention Hierarchy (Ancestors)

Therapeutics; Pressure; Mechanical Phenomena; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 30, 2023

Record last verified: 2023-10