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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01899807
Recruitment Status : Unknown
Verified March 2015 by Dr. Kalle Lundgren, Karolinska University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 15, 2013
Last Update Posted : March 31, 2015
Information provided by (Responsible Party):
Dr. Kalle Lundgren, Karolinska University Hospital

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.

Condition or disease Intervention/treatment Phase
Defect of Skull Ossification Other Specified Skull or Face Bone Anomaly Cranial Dysostosis Nec Hemicraniectomy Device: OssDsign AB Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2013
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Single Arm Device: OssDsign AB

Primary Outcome Measures :
  1. 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 :
  1. Percentage subjects with an adverse event [ Time Frame: From the date of intervention up to 14 days, 3 months, 6 months follow-up ]
  2. 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

  3. 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.

  4. 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:
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Dr. Kalle Lundgren, MD, PhD, Karolinska University Hospital Identifier: NCT01899807     History of Changes
Other Study ID Numbers: OQ-CR-001
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases