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RecruitingNCT07893132Updated Oct 23, 2026

Archive of Custom-made Guides for Orthopedic Surgery

An observational study in Deformity of Bone, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Istituto Ortopedico Rizzoli · Observational

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Updated Oct 23, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
2 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Deformity of Bone

Keywords

  • custom made
  • Cutting Guides
  • Orthopedics
  • surgical planning
03

In context

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

all patients undergoing GSM surgery at the IOR

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

EXCLUSION CRITERIA:

  • Patients under 2 years of age
  • Patients who do not require GSM intervention
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients

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

    Other: Archive

Interventions

  • OtherArchive

    Archive and planning of surgical guides

06

What researchers measure

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.

    Time frame: at baseline (day 0)

07

Study locations

1 of 1 sites recruiting
  • IRCCS Istituto Ortopedico Rizzoli
    Bologna, 40136, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07893132
Responsible party
Sponsor
First posted
Oct 23, 2026
Start date
Feb 20, 2025
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Oct 23, 2026

Study contacts

Claudio Belvedere, PHD
Contact
belvedere@ior.it
0516366796

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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