Status:
RECRUITING
Radiological Evaluation of 3D Printed Porous Collars in Hip and Knee Resection Prostheses: Pilot Study.
Lead Sponsor:
Regina Elena Cancer Institute
Collaborating Sponsors:
San Filippo Neri General Hospital
Istituto Ortopedico Rizzoli
Conditions:
Bone Tumor
Eligibility:
All Genders
18+ years
Brief 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 t...
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...
Eligibility Criteria
Inclusion
- age \> 18 years at the time of surgery.
- patients undergoing hip and knee resection prosthesis surgery with the use of collars porous 3D printed.
- date of intervention: starting from the regular entry into use of 3D printed porous collars at the reference center.
- Patients operated on for primary tumor outcomes.
- Patients operated on for infection.
- Patients operated for revisions with severe loss of bone substance.
- Patients capable of giving informed consent and obtaining written informed consent (prospective part/patients in follow-up).
Exclusion
- Patients lost to follow-up and/or for whom radiographic and clinical documentation is not available corresponding to the post-operative moment and the clinical follow-up visit (6 months and 1 years).
Key Trial Info
Start Date :
December 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06180525
Start Date
December 1 2022
End Date
June 1 2024
Last Update
March 22 2024
Active Locations (1)
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1
"Regina Elena" National Cancer Institute
Rome, Italy, 00144