Degenerative Lumbar Spinal Stenosis
Conditions
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.
Detailed description
The primary endpoint is the successful fusion rate in radiographic assessment at more than 2 years.
Interventions
PROCEDURESurgery with FACET FIXATION implants
Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with FACET FIXATION implants
PROCEDURESurgery with Pedicle Screw
Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw
Sponsors
SC Medica
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of fusion | 2 years | 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. |
Countries
France
Contacts
Primary ContactAurélie MULLER
Outcome results
None listed