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

NCT06106061 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2023-10-30

No results posted yet for this study

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

Interventions

DEVICE

Decompression + FFX®

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

PROCEDURE

Decompression alone

Surgical treatment of degenerative lumbar spinal stenosis by spinal decompression alone

Sponsors & Collaborators

  • SC Medica

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2026-11-30
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06106061 on ClinicalTrials.gov