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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery with FACET FIXATION implants | Procedure | Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with FACET FIXATION implants |
|
| Measure | Description | Time Frame |
|---|---|---|
| The 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 :
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. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of adult patients diagnosed with degenerative lumbar spinal stenosis who underwent their first spinal operation for lumbar decompression with pedicle screws fixation or FACET FIXation implant from 2015 to 2020 (2015-2016 with Pedicle Screw and starting November 2017 with more than 2 years postop at the date of the visit with FACET FIXation implant).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurélie MULLER | Contact | 3 88 23 71 04 | +33 | am@sc-medica.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Civils de Colmar | Recruiting | Colmar | France |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D065289 | Pedicle Screws |
| ID | Term |
|---|---|
| D001863 | Bone Screws |
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Surgery with Pedicle Screw | Procedure | Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw |
|
| D009984 |
| Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |