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The CranioFix®2 PMCF study has been set up as an action within the framework of a proactive post-market surveillance system of the manufacturer. The aim of this observational study is to collect systematically and proactively data regarding the performance of CranioFix®2, like adverse events (AEs), handling and cosmetic outcome, under daily clinical practice when used as intended by the manufacturer.
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| Measure | Description | Time Frame |
|---|---|---|
| Planarity of Bone Flap After Implantation | The primary variable was the planarity of the bone flap after implantation. The bone flap planarity was evaluated as the rate of patients in which a dislocation of the bone flap occurred - defined as the height of the tilting (depression / protrusion) greater than the bone width. | Through postoperative course: at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (Intra- and Postoperative) | Number of adverse events e.g. foreign body reactions, infections, injury to the dura, injury to the scalp, epiduralhaematoma, wound healing disorders with special focus on (serious) adverse events with (possible) relation to the investigational product | through study completion, an average of 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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All patients enrolled will be prospectively examined according to the study plan until follow-up examination (depending on routine in clinic).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Stuttgart - Katharinenhospital | Stuttgart | 70174 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational Study Group | All patients that were included in the study received treatment with the investigational device according to site's clinical routine. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational Study Group | All patients that were included in the study received treatment with the investigational device according to site's clinical routine. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Planarity of Bone Flap After Implantation | The primary variable was the planarity of the bone flap after implantation. The bone flap planarity was evaluated as the rate of patients in which a dislocation of the bone flap occurred - defined as the height of the tilting (depression / protrusion) greater than the bone width. | Posted | Count of Participants | Participants | Through postoperative course: at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months after surgery) |
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3 ± 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational Study Group | In total, 3 adverse events were reported in 3 study patients. Two of the three AEs were classified as serious adverse events. In 2 of the AEs a measure was taken which included non-operative measures (n = 1) and reoperation (n = 1), in 1 of the AE no therapeutic measure due to the AE was taken (n=1). No causal relationship to the investigational device was stated in any of the cases. Consequently, none of the AE is related to be an ADE (Adverse Device Effect). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intracerebral hemorrhage after resection with generalized seizure and hemiparesis on the right side. | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epidural collection of liquid and air in access area, non-space-consuming.Clinically inapparent. | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana Kupferschmid, Study Manager of B. Braun | B.Braun Aesculap | 0049746195 | 0 | studies@aesculap.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2024 | Mar 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012887 | Skull Fractures |
| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D050723 | Fractures, Bone |
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| Overall Handling of Instruments for CranioFix®2 System Implantation Documented on a Likert Scale | Assessment of handling, documented on a Likert scale 1 to 5 (1 is the very good, 2 is good, 3 is acceptable, 4 is poor, 5 is very poor) | intraoperative |
| Stability of the Bone Flap After Fixation | Assessment of stability of the bone flap, documented on a Likert scale 1 to 5 (1≙very good, 2≙good, 3≙medium, 4≙poor, 5≙very poor) | intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months) |
| Cosmetic Outcome | Assessment of cosmetic outcome intraoperatively, at discharge and at post-operative follow-up documented on a 3 point scale (good, fair, bad) | intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
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| Secondary | Number of Participants With Adverse Events (Intra- and Postoperative) | Number of adverse events e.g. foreign body reactions, infections, injury to the dura, injury to the scalp, epiduralhaematoma, wound healing disorders with special focus on (serious) adverse events with (possible) relation to the investigational product | Posted | Count of Participants | Participants | through study completion, an average of 3 months |
|
|
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| Secondary | Overall Handling of Instruments for CranioFix®2 System Implantation Documented on a Likert Scale | Assessment of handling, documented on a Likert scale 1 to 5 (1 is the very good, 2 is good, 3 is acceptable, 4 is poor, 5 is very poor) | Posted | Number | participants | intraoperative |
|
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| Secondary | Stability of the Bone Flap After Fixation | Assessment of stability of the bone flap, documented on a Likert scale 1 to 5 (1≙very good, 2≙good, 3≙medium, 4≙poor, 5≙very poor) | One of 25 patients died after surgery before discharge, 7 patients were lost to follow-up between discharge and follow up visit. | Posted | Count of Participants | Participants | intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months) |
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| Secondary | Cosmetic Outcome | Assessment of cosmetic outcome intraoperatively, at discharge and at post-operative follow-up documented on a 3 point scale (good, fair, bad) | At the discharge visit, in 2 cases no evaluation of the cosmetic outcome by the surgeon was available because in one case no MRI scan was conducted and in another case the patient died after surgery before discharge. At the follow-up visit, in 8 cases, no evaluation of the cosmetic outcome was available because the follow-up visit did not take place. | Posted | Count of Participants | Participants | intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months) |
|
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| 1 |
| 25 |
| 2 |
| 25 |
| 1 |
| 25 |
Probably the hemorrhage was caused by occlusion of the draining veine.
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| Intracerebral hemorrhage after resection | Injury, poisoning and procedural complications | Systematic Assessment | Probably the bleeding was caused by the tumor resection. |
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Extension of epidural space might be caused by large defect of brain
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The clinic will ensure that a manuscript intended for publication that is related to this study is made available to the sponsor for review before submission in order to give the sponsor the opportunity to comment. Furthermore, the clinic ensures that an abstract intended for presentation, as well as a manuscript intended for this purpose and the presentation slides themselves, are sent to the sponsor before submission to a congress.
| D014947 |
| Wounds and Injuries |
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| poor |
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| very poor |
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| acceptable |
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| could not be evaluated |
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| at discharge |
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| at follow up (3±2 months |
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| bad |
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| could not be evaluated |
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| Cosmetic outcome by surgeon (discharge) |
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| Cosmetic outcome by surgeon (follow up) |
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| Cosmetic outcome by patient (discharge) |
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| Cosmetic outcome by patient (follow up) |
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