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

SC Medica

Status: Enrolling

Conditions: Degenerative Lumbar Spinal Stenosis

Treatments: Procedure: Surgery with Pedicle Screw; Procedure: Surgery with FACET FIXATION implants

Study type: Observational

Funder types: Industry

Identifiers

NCT05645497

2022-A01783-40

Details and patient eligibility

About

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.

Full description

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

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

116 participants in 2 patient groups

Patient with medical device FACET FIXATION

Description:

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).

Treatment:

Procedure: Surgery with FACET FIXATION implants

Patient with medical device Pedicle Screw

Description:

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.

Treatment:

Procedure: Surgery with Pedicle Screw