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.
The primary endpoint is the successful fusion rate in radiographic assessment at more than 2 years.
Study Type
OBSERVATIONAL
Enrollment
116
Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with FACET FIXATION implants
Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw
Hôpitaux Civils de Colmar
Colmar, France
RECRUITINGThe 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.
Time frame: 2 years
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