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
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.
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.
all patients undergoing GSM surgery at the IOR
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EXCLUSION CRITERIA:
all patients treated using custom made devices at IRCCS Istituto Ortopedico Rizzoli
Other: Archive
Archive and planning of surgical guides
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)
Plan to share: Undecided
No publications or documents are linked to this record.
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 ↗
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