Bone Reconstruction of the Skull Using a Metal Ceramic Implant After Previously Failed Reconstruction

Karolinska University Hospital

Status

Unknown

Conditions

Defect of Skull Ossification

Cranial Dysostosis Nec

Hemicraniectomy

Other Specified Skull or Face Bone Anomaly

Treatments

Device: OssDsign AB

Study type

Interventional

Funder types

Other

Identifiers

NCT01899807

OQ-CR-001

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.