Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06106061
NA

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

Sponsor: SC Medica

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2023-11

Completion Date

2026-11

Last Updated

2023-10-30

Healthy Volunteers

No

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