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

NCT06180525 | Recruiting

• 1 other identifier: RS1793/22(2702)
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Tumor

Keywords

Radiological evaluation; Clinical evaluation

Outcome Measures

Primary Outcomes (1)

• Radiological evaluation

  Osseointegration will be assessed by x-ray analysis 6 months and 1 year after surgery

  6 months and 1 year

Secondary Outcomes (1)

• QoL evaluation

  6 months and 1 year

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 30 patients will be enrolled consecutively (of which 10 patients consecutively retrospective).

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• San Filippo Neri General Hospital: collaborator
• Istituto Ortopedico Rizzoli: collaborator
• A.O.U. Città della Salute e della Scienza: collaborator

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Nicola Salducca

CONTACT

06-5266.6894; nicola.salducca@ifo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: December 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

IT (1)