Hip Prosthesis Infection Clinical Trial
Official title:
CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)
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.
n/a
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