Clinical trial NCT06180525: Radiological Evaluation of 3D Printed Porous Collars in Hip and Knee Resection Prostheses: Pilot Study.
Official title: Radiological Evaluation of 3D Printed Porous Collars in Resection Prostheses Hip and Knee: Pilot Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Tumor
Keywords: Radiological evaluation
Clinical evaluation
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: San Filippo Neri General Hospital
name: Istituto Ortopedico Rizzoli
name: A.O.U. Città della Salute e della Scienza
First posted: 2023-12-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 30 patients will be enrolled consecutively (of which 10 patients consecutively retrospective).

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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).

Primary outcomes:
measure: Radiological evaluation
timeFrame: 6 months and 1 year
Secondary outcomes:
measure: QoL evaluation
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References: