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| ID | Type | Description | Link |
|---|---|---|---|
| NL34808.100.10 | Registry Identifier | Netherlands Clinical Trials Registry |
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This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will measure and compare pain and disability improvement with the two implanted devices over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEEK interbody cage | Active Comparator | Posterior fusion with an interbody spacer (cage) made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is filled with local bone or bone harvested from the iliac crest. |
|
| Valeo OL ceramic cage | Experimental | Posterior fusion with the Valeo OL cage, a silicon nitride ceramic interbody spacer. The center area of the cage is filled with autograft local bone or bone harvested from the iliac crest. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior lumbar interbody fusion with a PEEK cage | Device | PEEK cage suitable for oblique placement in the lumbar spine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Roland Morris Disability Questionnaire (RMDQ) | The improvement in the RMDQ over the pre-op RMDQ value for each group will be compared | 12 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Fusion status | Plane film radiographs will be used to assess fusion at all four follow-up periods. At 12 months a CT scan will be performed. | 3 mo., 6 mo., 12 mo., 24 months |
| Oswestry Disability Index (ODI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center Haaglanden | The Hague | 2501 CK | Netherlands | |||
| Diakonessenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24568365 | Derived | Kersten RF, van Gaalen SM, Arts MP, Roes KC, de Gast A, Corbin TP, Oner FC. The SNAP trial: a double blind multi-center randomized controlled trial of a silicon nitride versus a PEEK cage in transforaminal lumbar interbody fusion in patients with symptomatic degenerative lumbar disc disorders: study protocol. BMC Musculoskelet Disord. 2014 Feb 25;15:57. doi: 10.1186/1471-2474-15-57. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 13, 2021 | |
| Reset | Feb 2, 2021 | |
| Release | May 17, 2021 |
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| Posterior lumbar interbody fusion with a Valeo OL cage | Device | Posterior lumbar interbody fusion with a single Valeo OL ceramic cage. |
|
|
The improvement in the ODI over the pre-op ODI for each Group
| 12 months post-op |
| Utrecht |
| Netherlands |
| Reset | Jun 9, 2021 |
| Release | Aug 11, 2021 |
| Reset | Sep 7, 2021 |
| Release | Oct 25, 2021 |
| Reset | Nov 24, 2021 |
| Release | Dec 10, 2021 |
| Reset | Mar 2, 2022 |
| Release | May 4, 2022 |
| Reset | Feb 1, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 13, 2021 | Feb 2, 2021 | |||
| May 17, 2021 | Jun 9, 2021 | |||
| Aug 11, 2021 | Sep 7, 2021 | |||
| Oct 25, 2021 | Nov 24, 2021 | |||
| Dec 10, 2021 | Mar 2, 2022 | |||
| May 4, 2022 | Feb 1, 2023 |
| ID | Term |
|---|---|
| D013168 | Spondylolisthesis |
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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