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

NCT05645497 | Unknown

• 1 other identifier: 2022-A01783-40
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Surgery with FACET FIXATION implants PROCEDURE

Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with FACET FIXATION implants

Patient with medical device FACET FIXATION

Surgery with Pedicle Screw PROCEDURE

Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw

Patient with medical device Pedicle Screw

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SC Medica: lead

Study Sites (1)

Hôpitaux Civils de Colmar

Colmar, France

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative; Pedicle Screws

Intervention Hierarchy (Ancestors)

Bone Screws; Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Central Study Contacts

Aurélie MULLER

CONTACT

3 88 23 71 04; am@sc-medica.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: January 17, 2023
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)