Evaluation of the Efficacy and Safety of the FACET FIXation Implant.
NCT ID: NCT05645497
Last Updated: 2023-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
116 participants
OBSERVATIONAL
2023-01-17
2023-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patient with medical device FACET FIXATION
The FACET FIXATION group include all the patients with Lumbar Spinal Stenosis who underwent an open technique for decompression, specifically laminectomies, concomitant to FACET FIXATION from November 2017 (and having more than 2 years postop to date).
Surgery with FACET FIXATION implants
Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with FACET FIXATION implants
Patient with medical device Pedicle Screw
The Pedicle Screw group consiste of all the patients with Lumbar Spinal Stenosis who underwent an open technique for decompression, specifically laminectomies, concomitant to Pedicle Screw fixation from 2015 to 2016.
Surgery with Pedicle Screw
Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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SC Medica
INDUSTRY
Responsible Party
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Locations
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Hôpitaux Civils de Colmar
Colmar, , France
Countries
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Central Contacts
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Facility Contacts
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Robin SROUR, MD
Role: primary
Role: backup
Other Identifiers
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2022-A01783-40
Identifier Type: -
Identifier Source: org_study_id
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