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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Karolinska University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Rate of adverse events [ Time Frame: From the date of intervention up to 12 months post intervention ]

Adverse events defined as rupture of skin at or around implant area and/or clinical evidence of infection at or around implant area, which necessitates explantation.


Current Secondary Outcome:

  • 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)


Original Secondary Outcome:

  • 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 flouride) 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)


Information By: Karolinska University Hospital

Dates:
Date Received: July 2, 2013
Date Started: June 2013
Date Completion: March 2016
Last Updated: March 30, 2015
Last Verified: March 2015