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

Last updated: April 11, 2023
Sponsor: SC Medica
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Stenosis

Spondylolisthesis

Treatment

N/A

Clinical Study ID

NCT05645497
2022-A01783-40
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 spinalstenosis
  • Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression withPedicle 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

Exclusion Criteria:

  • Patient received FACET FIXation implant or Pedicle Screw fixation with supplementalinterbody 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 oradministrative decision).
  • Patient not covered by a social security scheme.

Study Design

Total Participants: 116
Study Start date:
January 17, 2023
Estimated Completion Date:
April 30, 2023

Study Description

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

Connect with a study center

  • Hôpitaux Civils de Colmar

    Colmar,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.