Deformity of BoneNCT07893132
Archive of Custom-made Guides for Orthopedic Surgery
An observational study of Deformity of Bone, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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'). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Deformity of Bone
- What is being tested?
- Archive
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients undergoing GSM surgery at the IOR
Who may be able to join
- Patients of both sexes aged 2 years or older
- Patients on the list at the IOR Operating Units for GSM surgery
Who cannot join
- Patients under 2 years of age
- Patients who do not require GSM intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
Claudio Belvedere, PHD, belvedere@ior.it
About this study
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
- Being tested
- Archive
- Keywords
- custom made, Cutting Guides, Orthopedics, surgical planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArchiveOther
Archive and planning of surgical guides
| Study group | Role | What they receive |
|---|---|---|
| patients | all patients treated using custom made devices at IRCCS Istituto Ortopedico Rizzoli Receives: Other: Archive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start20 Feb 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deformity of BoneStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893132
- Sponsor's protocol ID
- GSM - Tailor-made Guides
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Archive of Custom-made Guides for Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT07893132
- Acronym / sponsor ID
- GSM - Tailor-made Guides
- Conditions
- Deformity of Bone
- Keywords
- custom made, Cutting Guides, Orthopedics, surgical planning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Other: Archiveall patients treated using custom made devices at IRCCS Istituto Ortopedico Rizzoli |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients undergoing GSM surgery at the IOR
Key inclusion criteria (2 listed)
- Patients of both sexes aged 2 years or older
- Patients on the list at the IOR Operating Units for GSM surgery
Key exclusion criteria (2 listed)
- Patients under 2 years of age
- Patients who do not require GSM intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArchiveArchive and planning of surgical guides | Other | patients |
Primary outcome
Rate of orthopedic cutting guides successfully recorded in the data collection archive at baseline
Time frame: at baseline (day 0)
The number or percentage of orthopedic cutting guides with complete design and surgical parameters successfully registered in the monitoring archive on day 0.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Deformity of Bone
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingObservational study
Natural History of Glycosphingolipid Storage Disorders and Glycoprotein Disorders
Neurological Regression, Myoclonus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deformity of Bone, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio Belvedere, PHD (0516366796, belvedere@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of orthopedic cutting guides successfully recorded in the data collection archive at baseline (time frame: at baseline (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.