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Clinical Trial Summary

Open-label, multicentre, prospective cohort, observational clinical trial with a retrospective control group to evaluate the effectiveness and safety of CERAMENTTM| G or V used for filling of bone defects in the tibia and / or femur shaft and/or acetabulum in patients scheduled for two-stage hip or knee prosthesis re-implantation for PJI or aseptic loosening.

The results will be compared to a cohort of patients, which have been treated before the introduction of CERAMENTTM|G or V for the same indication.

Due to the observational character of the study, there will be no patient randomization and the clinicians in the study will remain entirely free to decide on the treatment of the patients according to established clinical practice.

Only patients for whom therapeutic strategy for the use of the product for filling bone defects is already planned according to local clinical practice, at the time of informed consent form signature, will be enrolled in this study. Thus, the decision for the choice of the surgical treatment, will not be influenced by the inclusion of the patient in this study.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03389646
Study type Interventional
Source Istituto Ortopedico Galeazzi
Contact CARLO L ROMANO, MD
Phone +39026621441
Email carlo.romano@grupposandonato.it
Status Recruiting
Phase Phase 4
Start date September 27, 2017
Completion date September 27, 2019

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