Evaluation of the Efficacy and Safety of the FACET FIXation Implant.

Recruiting

• Conditions: Degenerative Lumbar Spinal Stenosis
• Interventions: Procedure: Surgery with Pedicle Screw; Procedure: Surgery with FACET FIXATION implants

• Registration Number: NCT05645497
• Lead Sponsor: SC Medica

Brief Summary

This is a single center, hybrid retrospective and prospective (ambispective) study to evaluate the safety and efficacy of the Facet Fixation implant.

The main objective is to evaluate the efficacy of the Facet Fixation implant compared with pedicle screw fixation to determine successful fusion in radiographic assessment at more than two years. Fusion is mainly defined as any sign of bony fusion between the facet joints or transverse processes when viewing the postoperative CT-scan at over 2 years.

Detailed Description

The primary endpoint is the successful fusion rate in radiographic assessment at more than 2 years.

Study Timeline

• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-09
• Study Start: 2023-01-17
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Patient is ≥ 18 years old at the time of the surgery
• The first back operation in the patient's life was for degenerative lumbar spinal stenosis
• Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw fixation or FACET FIXation implant.
• Patient is able to understand the information related to the study
• Patient consents to participate to the clinical investigation and agrees (non-objection) on the use of his/her personal data.

Exclusion Criteria

• Patient received FACET FIXation implant or Pedicle Screw fixation with supplemental interbody cages.
• Unilateral Pedicle Screw or FACET FIXation implant.
• Preoperative grade ≥II spondylolisthesis
• Preoperative scoliotic deviations >25°.
• Protected patient (under legal protection, deprived of liberty by judicial or administrative decision).
• Patient not covered by a social security scheme.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with medical device Pedicle Screw	Surgery with Pedicle Screw	The Pedicle Screw group consiste of all the patients with Lumbar Spinal Stenosis who underwent an open technique for decompression, specifically laminectomies, concomitant to Pedicle Screw fixation from 2015 to 2016.
Patient with medical device FACET FIXATION	Surgery with FACET FIXATION implants	The FACET FIXATION group include all the patients with Lumbar Spinal Stenosis who underwent an open technique for decompression, specifically laminectomies, concomitant to FACET FIXATION from November 2017 (and having more than 2 years postop to date).

Primary Outcome Measures

Name	Time	Method
The rate of fusion	2 years	The proportion of patients achieving the primary endpoint will be evaluated. The rate of fusion in the radiographic assessment is considered successful if all of the following criteria are achieved : * Evidence of bridging bone between the facet joints (Facet Fixation implant) or the transverse processes (pedicle screws) via computed tomography scan.; * and ≤ 3mm translational motion between vertebrae on flexion / extension via dynamic X-rays.; * and no evidence of lucency surrounding the device (≤25%).; The main analysis will compare the successful fusion rate at 2+ years post-operative between the group with the Facet Fixation and the group with pedicle screws, by a confidence interval approach.

Trial Locations

Locations (1)

Hôpitaux Civils de Colmar; 🇫🇷 Colmar, France