Clinical trial NCT01899807: Bone Reconstruction of the Skull Using a Metal Ceramic Implant After Previously Failed Reconstruction
Official title: Cranial Reconstruction With Patient-specific Titanium Mesh/Mosaic-designed Calcium Phosphate-implant - A Multi Center Center, Single Arm, Non-comparative Prospective Case Series
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Defect of Skull Ossification
Other Specified Skull or Face Bone Anomaly
Cranial Dysostosis Nec
Hemicraniectomy
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate a new ceramic metal bone graft substitute for hemi craniectomies. The frequency of infections and rupture of skin will be studied, which is a reoccurring problem with currently used bone graft substitutes in this subject population. In addition, the quality of life before and after implantation will be evaluated as well as the bone regeneration around implant.


Eligibility criteria: Inclusion Criteria:

* Obtained informed consent.
* Males or females, ≥18 years of age
* Subject with cranial defect size \> 25 cm2.
* History of previous cranial implant failure and where the latest cranial reconstruction failed within 12 months. (This means that the patient demonstrates a non-reconstructed cranial defect after removal of implant or exhibit an implant failure, e.g. local infection and/or protrusion through the skin.)
* Willing and able to comply with all study procedures and restrictions.
* The 5 subjects participating in bone regeneration analysis (PET/CT scans) has to be 50 years or older

Exclusion Criteria:

* Malignancy adjacent to the reconstruction area, including brain and calvaria, with on-going or planned surgical intervention.
* Pregnant or nursing women.

Exclusion criteria during surgery, if applicable:

Perioperative appearance of previously not identified tumor or infection in the reconstruction area.

Primary outcomes:
measure: Rate of adverse events
timeFrame: From the date of intervention up to 12 months post intervention
Secondary outcomes:
measure: Percentage subjects with an adverse event
timeFrame: From the date of intervention up to 14 days, 3 months, 6 months follow-up
measure: Quality of life scores
timeFrame: Assessed during the 3 month- and 12 month follow-up visit post intervention, compared to the screening visit: 3-0 weeks prior to intervention
measure: PET/CT analysis with bone tracer, confirms bone regeneration activity within the reconstruction area
timeFrame: The PET/CT scan will be taken at 12 months post intervention and it will be compared with 2 weeks post intervention
measure: Subject mean MOCA
timeFrame: 3 months and 12 months follow-up compared to baseline
Other outcomes:
measure: Health economy variables
timeFrame: 3 months and 12 months post intervention compared to baseline visit: 3-0 weeks pre intervention
Locations:
city: Gothenburg
country: Sweden
facility: Dept. of Neurosurgery, Sahlgrenska University Hospital
city: Stockholm
country: Sweden
facility: Dept. of Neurosurgery, Karolinska Universitetssjukhuset
Study officials:
affiliation: Department of Neurosurgery, Karolinska University Hospital
name: Lars Kihlström, MD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Kalle Lundgren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: