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

Not Applicable

• Conditions: Other Specified Skull or Face Bone Anomaly; Cranial Dysostosis Nec; Hemicraniectomy; Defect of Skull Ossification
• Interventions: Device: OssDsign AB

• Registration Number: NCT01899807
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-15
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-03-31
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	OssDsign AB	-

Primary Outcome Measures

Name	Time	Method
Rate of adverse events	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

Name	Time	Method
Quality of life scores	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	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.
Percentage subjects with an adverse event	From the date of intervention up to 14 days, 3 months, 6 months follow-up
Subject mean MOCA	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)

Trial Locations

Locations (2)

Dept. of Neurosurgery, Karolinska Universitetssjukhuset; 🇸🇪 Stockholm, Sweden

Dept. of Neurosurgery, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden