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| Name | Class |
|---|---|
| San Filippo Neri General Hospital | OTHER |
| Istituto Ortopedico Rizzoli | OTHER |
| A.O.U. Città della Salute e della Scienza | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective part | Patients for whom follow-up data up to at least 1 year after surgery is available at the start of the study. | ||
| Prospective part | Both for patients not yet undergoing treatment 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), will begin once all necessary authorizations have been obtained administrative requests |
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| Measure | Description | Time Frame |
|---|---|---|
| Radiological evaluation | Osseointegration will be assessed by x-ray analysis 6 months and 1 year after surgery | 6 months and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 30 patients will be enrolled consecutively (of which 10 patients consecutively retrospective).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicola Salducca | Contact | 06-5266.6894 | nicola.salducca@ifo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Regina Elena" National Cancer Institute | Recruiting | Rome | 00144 | Italy |
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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