NCT06180525

Radiological Evaluation of 3D Printed Porous Collars in Hip and Knee Resection Prostheses: Pilot Study.

Radiological Evaluation of 3D Printed Porous Collars in Resection Prostheses Hip and Knee: Pilot Study.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Bone Tumor

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2023-12-22
• Last updated: 2024-03-22

Locations

1 site across 1 country: Italy