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

Launched by SC MEDICA · Dec 1, 2022

Keywords

ClinConnect Summary

The clinical trial titled "Evaluation of the Efficacy and Safety of the FACET FIXation Implant" is studying a new device called the Facet Fixation implant, which is used to treat a condition known as degenerative lumbar spinal stenosis. This condition involves narrowing of the space around the spinal cord in the lower back, leading to pain and other symptoms. The trial aims to compare the effectiveness of the Facet Fixation implant to a traditional treatment method using pedicle screws, focusing on whether the bones fuse properly after surgery. The researchers will look for signs of successful fusion in the spine through imaging tests more than two years after the surgery.

To participate in this trial, individuals must be at least 18 years old and undergoing their first surgery for degenerative lumbar spinal stenosis. Participants will receive either the Facet Fixation implant or pedicle screw fixation as part of their treatment. They should be able to understand the study information and agree to take part. It's important to note that certain conditions, such as previous spinal surgeries or specific spinal deformities, may exclude someone from joining. Overall, participants will be contributing to valuable research that could improve treatment options for others with this back condition.

Gender

ALL

Eligibility criteria

• 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.