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

NCT01899807 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2015-03-31

No results posted yet for this study

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.

Conditions

  • Defect of Skull Ossification
  • Other Specified Skull or Face Bone Anomaly
  • Cranial Dysostosis Nec
  • Hemicraniectomy

Interventions

DEVICE

OssDsign AB

Sponsors & Collaborators

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Lars Kihlström, MD, MBA · Department of Neurosurgery, Karolinska University Hospital

  • Kalle Lundgren, MD, PhD · Karolinska University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01899807 on ClinicalTrials.gov