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RECRUITING
NCT07893132

Archive of Custom-made Guides for Orthopedic Surgery

Sponsor: Istituto Ortopedico Rizzoli

View on ClinicalTrials.gov

Summary

The present study aims to design, develop and test an electronic archive to be able to track over time the so-called Patient-Specific Cutting Guides for Orthopedics (in English often known as ' Pa-tient-Specific Cutting Guides'). Surgical Guides (or even more frequently, Patient-Specific-Instrumentation - PSI), i.e., based on medical images of the specific patient undergoing surgery. These are becoming increasingly necessary for complex surgeries, or those requiring careful pre-operative planning, to support both standard and customized metal implants (i.e., those individual-ly made using so-called "3D printing" or "additive manufacturing" techniques, hereinafter referred to as "custom" implants), as well as corrective osteotomies for cases of severe skeletal deformity. From a technical standpoint, it will be necessary to evaluate whether the compilation of the con-trolled-access archive of these surgical guides will be provided and automated by the software tools currently used for their design, or whether the use of an additional standard platform (such as REDCap) will be deemed suitable, or whether the development of an ad-hoc database will be necessary.

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2025-02-20

Completion Date

2027-01

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

OTHER

Archive

Archive and planning of surgical guides

Locations (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy