Archive of Custom-made Guides for Orthopedic Surgery

NCT07893132 | Recruiting

• 1 other identifier: GSM - Tailor-made Guides
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Deformity of Bone

Keywords

custom made; Cutting Guides; Orthopedics; surgical planning

Outcome Measures

Primary Outcomes (1)

• Rate of orthopedic cutting guides successfully recorded in the data collection archive at baseline

  The number or percentage of orthopedic cutting guides with complete design and surgical parameters successfully registered in the monitoring archive on day 0.

  at baseline (day 0)

Study Arms (1)

patients

all patients treated using custom made devices at IRCCS Istituto Ortopedico Rizzoli

Other: Archive

Interventions

Archive OTHER

Archive and planning of surgical guides

patients

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients undergoing GSM surgery at the IOR

You may qualify if:

• Patients of both sexes aged 2 years or older
• Patients on the list at the IOR Operating Units for GSM surgery

You may not qualify if:

• Patients under 2 years of age
• Patients who do not require GSM intervention

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Interventions

Archives

Intervention Hierarchy (Ancestors)

Information Centers; Non-Medical Public and Private Facilities

Central Study Contacts

Claudio Belvedere, PHD

CONTACT

0516366796; belvedere@ior.it

Study Design

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

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 23, 2026
• Study Start: February 20, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

IT (1)