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

Bone Tumor Clinical Trial

— COLLARS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180525
• Other study ID #: RS1793/22(2702)
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: Regina Elena Cancer Institute
• Contact: Nicola Salducca
• Phone: 06-5266.6894
• Email: nicola.salducca[@]ifo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Bone Neoplasms
• Bone Tumor

Locations

Country	Name	City	State
Italy	"Regina Elena" National Cancer Institute	Rome

Sponsors (4)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute	Azienda Ospedaliera Città della Salute e della Scienza di Torino, Istituto Ortopedico Rizzoli, San Filippo Neri General Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological evaluation	Osseointegration will be assessed by x-ray analysis 6 months and 1 year after surgery	6 months and 1 year
Secondary	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