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

Degenerative Lumbar Spinal Stenosis Clinical Trial

— FACETFIX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645497
• Other study ID #: 2022-A01783-40
• Status: Recruiting
• Start date: January 17, 2023
• Est. completion date: April 30, 2023

Study information

• Verified date: April 2023
• Source: SC Medica
• Contact: Aurélie MULLER
• Phone: 3 88 23 71 04
• Email: am[@]sc-medica.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Degenerative Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• Surgery with FACET FIXATION implants
Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with FACET FIXATION implants
• Surgery with Pedicle Screw
Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw

Locations

Country	Name	City	State
France	Hôpitaux Civils de Colmar	Colmar

Sponsors (1)

Lead Sponsor	Collaborator
SC Medica

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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