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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Dr. Kalle Lundgren, Karolinska University Hospital Identifier:
First received: July 2, 2013
Last updated: March 30, 2015
Last verified: March 2015
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.

Condition Intervention
Defect of Skull Ossification
Other Specified Skull or Face Bone Anomaly
Cranial Dysostosis Nec
Device: OssDsign AB

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Rate of adverse events [ Time Frame: From the date of intervention up to 12 months post intervention ]
    The primary endpoint, rate of adverse events, will be measured by clinical evidence of infection and/or manifested rupture of skin around the implant, within 12 months, that necessitates explantation.

Secondary Outcome Measures:
  • 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 ]
    SF-12 and EQ5D 3L will be used

  • 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 ]
    The bone tracer (18 F fluoride) will be used to measure bone regeneration.

  • Subject mean MOCA [ Time Frame: 3 months and 12 months follow-up compared to baseline ]
    Subject cognitive impairment is measured by Montreal Cognitive Assessment (MOCA) (the subject will be given a score after completing the assessment)

Other Outcome Measures:
  • Health economy variables [ Time Frame: 3 months and 12 months post intervention compared to baseline visit: 3-0 weeks pre intervention ]
    Mean number of hospital days, hospital visits, mean time to adverse event and lost work days related to the study treatment will be counted.

Enrollment: 11
Study Start Date: June 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm Device: OssDsign AB


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT01899807

Dept. of Neurosurgery, Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Dept. of Neurosurgery, Karolinska Universitetssjukhuset
Stockholm, Sweden
Sponsors and Collaborators
Karolinska University Hospital
Principal Investigator: Lars Kihlström, MD, MBA Department of Neurosurgery, Karolinska University Hospital
Principal Investigator: Kalle Lundgren, MD, PhD Karolinska University Hospital
  More Information

No publications provided

Responsible Party: Dr. Kalle Lundgren, MD, PhD, Karolinska University Hospital Identifier: NCT01899807     History of Changes
Other Study ID Numbers: OQ-CR-001
Study First Received: July 2, 2013
Last Updated: March 30, 2015
Health Authority: Sweden: Medical Products Agency processed this record on November 27, 2015