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

Cranial Reconstruction With Patient-specific Titanium Mesh/Mosaic-designed Calcium Phosphate-implant - A Multi Center Center, Single Arm, Non-comparative Prospective Case Series

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.

Study Overview

• Status: Unknown
• Conditions: Defect of Skull Ossification; Other Specified Skull or Face Bone Anomaly; Cranial Dysostosis Nec; Hemicraniectomy
• Intervention / Treatment: Device: OssDsign AB

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Dept. of Neurosurgery, Sahlgrenska University Hospital
  • Stockholm, Sweden
    • Dept. of Neurosurgery, Karolinska Universitetssjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm	Device: OssDsign AB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of adverse events	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.	From the date of intervention up to 12 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage subjects with an adverse event		From the date of intervention up to 14 days, 3 months, 6 months follow-up
Quality of life scores	SF-12 and EQ5D 3L will be used	Assessed during the 3 month- and 12 month follow-up visit post intervention, compared to the screening visit: 3-0 weeks prior to intervention
PET/CT analysis with bone tracer, confirms bone regeneration activity within the reconstruction area	The bone tracer (18 F fluoride) will be used to measure bone regeneration.	The PET/CT scan will be taken at 12 months post intervention and it will be compared with 2 weeks post intervention
Subject mean MOCA	Subject cognitive impairment is measured by Montreal Cognitive Assessment (MOCA) (the subject will be given a score after completing the assessment)	3 months and 12 months follow-up compared to baseline

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (Estimate): July 15, 2013

Study Record Updates

• Last Update Posted (Estimate): March 31, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Developmental; Dysostoses
• Other Study ID Numbers: OQ-CR-001