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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Karolinska University Hospital
Sponsor:
Information provided by (Responsible Party):
Dr. Kalle Lundgren, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01899807
First received: July 2, 2013
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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
Hemicraniectomy
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.


Estimated Enrollment: 11
Study Start Date: June 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm Device: OssDsign AB

  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899807

Contacts
Contact: Lars Kihlström, MD, MBA +46 73 6251801 lars.kihlstom@karolinska.se
Contact: Kalle Lundgren, MD, PhD +46 739824349 kalle.lundgren@ki.se

Locations
Sweden
Dept. of Neurosurgery, Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 413 45
Contact: Magnus Tisell, MD, PhD    +46734002029    magnus.tisell@vgregionen.se   
Principal Investigator: Magnus Tisell, MD, PhD         
Dept. of Neurosurgery, Karolinska Universitetssjukhuset Recruiting
Stockholm, Sweden
Contact: Lars Kihlström, MD,MBA,FRCPS    +46736251801    lars.kihlström@karolinska.se   
Principal Investigator: Lars Kihlström, MD,MBA,FRCPS         
Principal Investigator: Kalle Lundgren, MD, PhD         
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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
ClinicalTrials.gov Identifier: NCT01899807     History of Changes
Other Study ID Numbers: OQ-CR-001
Study First Received: July 2, 2013
Last Updated: March 26, 2014
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on September 18, 2014