This trial is active, not recruiting.

Conditions defect of skull ossification, other specified skull or face bone anomaly, cranial dysostosis nec, hemicraniectomy
Treatment ossdsign ab
Sponsor Karolinska University Hospital
Start date June 2013
End date March 2016
Trial size 11 participants
Trial identifier NCT01899807, OQ-CR-001


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
ossdsign ab

Primary Outcomes

Rate of adverse events
time frame: From the date of intervention up to 12 months post intervention

Secondary Outcomes

Percentage subjects with an adverse event
time frame: From the date of intervention up to 14 days, 3 months, 6 months follow-up
Quality of life scores
time frame: Assessed during the 3 month- and 12 month follow-up visit post intervention, compared to the screening visit: 3-0 weeks prior to intervention
PET/CT analysis with bone tracer, confirms bone regeneration activity within the reconstruction area
time frame: The PET/CT scan will be taken at 12 months post intervention and it will be compared with 2 weeks post intervention
Subject mean MOCA
time frame: 3 months and 12 months follow-up compared to baseline

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Lars Kihlström, MD, MBA
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Karolinska University Hospital.