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Clinical investigation to compare the clinical safety and performance of a clamp-like device for craniotomy closure, with the standard of care system, titanium plates and screws.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clamp-like system | Experimental |
| |
| Plates and screws | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clamp-like system | Device | Craniotomy closure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone flap alignment score | 1-4 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse effects and device deficiencies (device safety) | Frequency and type of Device related Adverse effects (AE and SAE) and device deficiencies | 6 months |
| Bone-flap alignment score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maribor University Medical Center | Maribor | Slovenia | ||||
| Hospital de la Santa Creu i Sant Pau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39584820 | Derived | Gomez de la Riva A, Rico M, Vorsic M, Rokavec V, Asencio-Cortes C, Munoz-Hernandez F. Multicenter Randomized Controlled Clinical Trial to Compare the Safety and Performance of Two Bone Flap Fixation Systems. Oper Neurosurg. 2024 Nov 25;29(3):337-344. doi: 10.1227/ons.0000000000001461. |
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| ID | Term |
|---|---|
| D001860 | Bone Plates |
| ID | Term |
|---|---|
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D009984 | Orthopedic Fixation Devices |
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| Plates and screws | Device | Craniotomy closure |
|
1-4
| 0-7 days after surgery (before discharge) |
| Surgeon usability questionnaire | Likert scale [1-7], where 1 is very difficult and 7 very easy | 0 days after surgery |
| Device related artefacts in neuroimaging | frequency | 6 months |
| Device-related bulges or visible offsets | frequency | 6 months |
| Post-craniotomy headache | Incidence | 6 months |
| Barcelona |
| 08041 |
| Spain |
| Hospital Universitario la Paz | Madrid | 28046 | Spain |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |