Evaluation of the Efficacy and Safety of the FACET FIXation Implant. (FACETFIX)

Evaluation of the Efficacy and Safety of the FACET FIXation Implant Compared With Pedicle Screw Fixation in Patients With Degenerative Lumbar Spinal Stenosis.

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.

Study Overview

• Status: Recruiting
• Conditions: Degenerative Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: Surgery with FACET FIXATION implants; Procedure: Surgery with Pedicle Screw

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 116

Contacts and Locations

• Study Contact: Name: Aurélie MULLER; Phone Number: +33 3 88 23 71 04; Email: am@sc-medica.com

Study Locations

• France
  • Colmar, France
    • Recruiting
    • Hopitaux Civils de Colmar
    • Contact: Robin SROUR, MD
    • Contact: Email: robin.srour@ch-colmar.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population will consist of adult patients diagnosed with degenerative lumbar spinal stenosis who underwent their first spinal operation for lumbar decompression with pedicle screws fixation or FACET FIXation implant from 2015 to 2020 (2015-2016 with Pedicle Screw and starting November 2017 with more than 2 years postop at the date of the visit with FACET FIXation implant).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with medical device FACET FIXATION; 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).	Procedure: Surgery with FACET FIXATION implants; Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with FACET FIXATION implants
Patient with medical device 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.	Procedure: Surgery with Pedicle Screw; Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of fusion	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.	2 years

Collaborators and Investigators

• Sponsor: SC Medica

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: 2022-A01783-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No