This study aims to evaluate the osseointegration of 3D printed porous collars in hip and knee resection prostheses, in order to eliminate one of the causes of diaphyseal osteolysis, which often lead to loosening of the implants, and therefore to guarantee a further improvement in fixation of the implants in terms of both primary and secondary stability.
Non-interventional, retro-prospective, non-pharmacological multicenter pilot study. The objective of the study is the radiological and clinical evaluation of collar osteointegration porous 3D printed in hip and knee resection prostheses. Aims to enroll patients undergoing resection prosthesis surgery hip and knee with the use of 3D printed porous collars, performed according to normal practice clinic at the institutions participating in the study. It is structured in a retrospective part which will evaluate the patients for whom follow-up data is available at the time of the start of the study up to at least 1 year after the operation. And a prospective part (both with regard to patients not yet subjected to intervention, at the start of the study, according to the inclusion criteria, both regarding those in follow-up for whom data are not available according to the time of observation required (1 year)) which will begin once all the necessary authorizations have been obtained administrative requests.
Study Type
OBSERVATIONAL
Enrollment
30
"Regina Elena" National Cancer Institute
Rome, Italy
RECRUITINGRadiological evaluation
Osseointegration will be assessed by x-ray analysis 6 months and 1 year after surgery
Time frame: 6 months and 1 year
QoL evaluation
Patient satisfaction/quality of life will be assessed 6 months and 1 year after surgery validated clinical questionnaire (Oxford score). Bone remodeling will be evaluated by x-ray analysis 6 months and 1 year after surgery. Number of adverse events of any nature during follow-up. Highlight any inter-observer variability in the detection of radiological measurements.
Time frame: 6 months and 1 year
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