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Not Yet Recruiting NCT05645497

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

Conditions: Degenerative Lumbar Spinal Stenosis

Sex: All
Ages: 18 Years – N/A
Enrollment: 116
Sponsor: SC Medica

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 Criteria:Patient is ≥ 18 years old at the time of the surgeryThe first back operation in the patient's life was for degenerative lumbar spinal stenosisSurgical 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 studyPatient 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 spondylolisthesisPreoperative scoliotic deviations >25°.Protected patient (under legal protection, deprived of liberty by judicial or administrative decision).Patient not covered by a social security scheme.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05645497). StuddyBuddy aggregates publicly available trial information.