Skull Fractures
Conditions
Keywords
Bone Flap Fixation, Fractures to the Neurocranium, Craniotomized bone flaps
Brief summary
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.
Interventions
None listed
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Age ≥ 18 years * Use of CranioFix®2 system according to IfU * Planned postoperative MRI within clinical routine
Exclusion criteria
* Pregnancy * Patients with hypersensitivity to metals or allergies to the implant materials * Inflammations in the region of the implant site * Bone conditions that rule out the application of CranioFix®2 titanium clamps * Use with artificial cranial bone flaps * Bone tumors in the area supporting the implant * Degenerative bone diseases * Missing dura mater * Application in the facial skull (viscerocranium) and in the orbital or skull-base region * Combination of implant components from different manufacturers, i.e. additional use of plates and screws on the same bone fragment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Planarity of Bone Flap After Implantation | Through postoperative course: at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months after surgery) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (Intra- and Postoperative) | through study completion, an average of 3 months | 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 |
| Overall Handling of Instruments for CranioFix®2 System Implantation Documented on a Likert Scale | intraoperative | 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) |
| Stability of the Bone Flap After Fixation | intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months) | 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) |
| Cosmetic Outcome | intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months) | Assessment of cosmetic outcome intraoperatively, at discharge and at post-operative follow-up documented on a 3 point scale (good, fair, bad) |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Observational Study Group All patients that were included in the study received treatment with the investigational device according to site's clinical routine. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 7 |
Baseline characteristics
| Characteristic | Observational Study Group | — |
|---|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 17 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 25 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 17 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 25 |
| other Total, other adverse events | 1 / 25 |
| serious Total, serious adverse events | 2 / 25 |
Outcome results
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.
Time frame: Through postoperative course: at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months after surgery)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Observational Study Group | Planarity of Bone Flap After Implantation | at discharge (about up to 2 weeks after surgery) | yes | 23 Participants |
| Observational Study Group | Planarity of Bone Flap After Implantation | at discharge (about up to 2 weeks after surgery) | no | 0 Participants |
| Observational Study Group | Planarity of Bone Flap After Implantation | at discharge (about up to 2 weeks after surgery) | could not be evaluated | 2 Participants |
| Observational Study Group | Planarity of Bone Flap After Implantation | post-operative follow-up (3±2 months after surgery) | yes | 17 Participants |
| Observational Study Group | Planarity of Bone Flap After Implantation | post-operative follow-up (3±2 months after surgery) | no | 0 Participants |
| Observational Study Group | Planarity of Bone Flap After Implantation | post-operative follow-up (3±2 months after surgery) | could not be evaluated | 8 Participants |
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)
Time frame: intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months)
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by surgeon (surgery) | good | 24 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by surgeon (surgery) | fair | 1 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by surgeon (surgery) | bad | 0 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by surgeon (surgery) | could not be evaluated | 0 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by surgeon (discharge) | good | 23 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by surgeon (discharge) | fair | 0 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by surgeon (discharge) | bad | 0 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by surgeon (discharge) | could not be evaluated | 1 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by surgeon (follow up) | good | 17 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by surgeon (follow up) | fair | 0 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by surgeon (follow up) | bad | 0 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by surgeon (follow up) | could not be evaluated | 0 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by patient (discharge) | good | 22 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by patient (discharge) | fair | 1 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by patient (discharge) | bad | 0 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by patient (discharge) | could not be evaluated | 1 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by patient (follow up) | good | 14 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by patient (follow up) | fair | 3 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by patient (follow up) | bad | 0 Participants |
| Observational Study Group | Cosmetic Outcome | Cosmetic outcome by patient (follow up) | could not be evaluated | 0 Participants |
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
Time frame: through study completion, an average of 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational Study Group | Number of Participants With Adverse Events (Intra- and Postoperative) | 3 Participants |
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)
Time frame: intraoperative
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Observational Study Group | Overall Handling of Instruments for CranioFix®2 System Implantation Documented on a Likert Scale | very good | 12 participants |
| Observational Study Group | Overall Handling of Instruments for CranioFix®2 System Implantation Documented on a Likert Scale | good | 12 participants |
| Observational Study Group | Overall Handling of Instruments for CranioFix®2 System Implantation Documented on a Likert Scale | acceptable | 1 participants |
| Observational Study Group | Overall Handling of Instruments for CranioFix®2 System Implantation Documented on a Likert Scale | poor | 0 participants |
| Observational Study Group | Overall Handling of Instruments for CranioFix®2 System Implantation Documented on a Likert Scale | very poor | 0 participants |
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)
Time frame: intraoperative, at discharge (about up to 2 weeks after surgery) and post-operative follow-up (3±2 months)
Population: One of 25 patients died after surgery before discharge, 7 patients were lost to follow-up between discharge and follow up visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Observational Study Group | Stability of the Bone Flap After Fixation | surgery | very good | 19 Participants |
| Observational Study Group | Stability of the Bone Flap After Fixation | surgery | good | 5 Participants |
| Observational Study Group | Stability of the Bone Flap After Fixation | surgery | acceptable | 1 Participants |
| Observational Study Group | Stability of the Bone Flap After Fixation | surgery | could not be evaluated | 0 Participants |
| Observational Study Group | Stability of the Bone Flap After Fixation | at discharge | very good | 15 Participants |
| Observational Study Group | Stability of the Bone Flap After Fixation | at discharge | good | 8 Participants |
| Observational Study Group | Stability of the Bone Flap After Fixation | at discharge | acceptable | 0 Participants |
| Observational Study Group | Stability of the Bone Flap After Fixation | at discharge | could not be evaluated | 1 Participants |
| Observational Study Group | Stability of the Bone Flap After Fixation | at follow up (3±2 months | very good | 11 Participants |
| Observational Study Group | Stability of the Bone Flap After Fixation | at follow up (3±2 months | good | 6 Participants |
| Observational Study Group | Stability of the Bone Flap After Fixation | at follow up (3±2 months | acceptable | 0 Participants |
| Observational Study Group | Stability of the Bone Flap After Fixation | at follow up (3±2 months | could not be evaluated | 0 Participants |