CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03389646|
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Hip Prosthesis Infection Knee Prosthesis Infection||Device: CERAMENT G V||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||135 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective with retrospective matched controls.|
|Masking:||None (Open Label)|
|Official Title:||CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)|
|Actual Study Start Date :||September 27, 2017|
|Estimated Primary Completion Date :||September 27, 2018|
|Estimated Study Completion Date :||September 27, 2019|
Active Comparator: Treated with Device: Including sham
Treated with CERAMENTTM|G or V for filling of bone defects in the tibia and/or femur and/or the acetabulum.
Device: CERAMENT G V
During the removal of hip and knee prostheses usually bone defects occur at the intramedullary canal of the tibia and or / femur and /or acetabulum. These bone defects are filled with CERAMENTTM|G or V during the re-implantation of the cementless or hybrid revision THA or TKA. CERAMENTTM|G or V can be directly injected into the intramedullary canal or bone defect at the acetabulum. Alternatively and preferably, the surface of the prostheses shafts can be used to transfer CERAMENTTM|G or V into the bone defects. For information of handling and mixing please see the attached instructions for use (IFU).
No Intervention: Control
Control without CERAMENT device
- incidence of post-surgical infection [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389646
|Contact: CARLO L ROMANO, MD||+39026621441 ext firstname.lastname@example.org|
|Contact: NICOLA LOGOLUSO, MD||+39026621441 ext email@example.com|
|Contact: CARLO L ROMANO, MD +39026621441 ext 907 firstname.lastname@example.org|
|Principal Investigator:||CARLO L ROMANO, MD||IRCCS GALEAZZI|