NCT03389646

CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Prosthesis Infection
• Knee Prosthesis Infection

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-09-27
• Primary completion: 2018-09-27
• Completion: 2019-09-27
• First posted: 2018-01-03
• Last updated: 2018-01-03

Locations

1 site across 1 country: Italy