Functional and Morphological Characterization of Multiple Osteochondromas Disorder (NCT06703736) | Clinical Trial Compass
RecruitingNot Applicable
Functional and Morphological Characterization of Multiple Osteochondromas Disorder
Italy60 participantsStarted 2025-05-21
Plain-language summary
The main purpose of the study is the characterization of functional and morphological alterations due to multiple osteochondromas in a pediatric and adult population through the identification of relevant anthropometric and functional parameters. The morphological and functional data, supplemented with clinical and postural data, will allow the characterization of the disease with an holistic approach that can provide important information to properly assess timing for surgical treatments and to improve the quality of life of these patients. Another goal of the study is the assessment and the validation of novel instruments and tools to measure joint mobility and bone deformity. These instruments should be easy-to-use and designed to be operated locally by the patients themselves and/or in small clinics by operators with little training and no specific high-technical knowledge. The final goal of the study is the assessment of the quality of life and balance perception of patients, using questionnaires.
Who can participate
Age range
6 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
For multiple osteochondromas cohort inclusion criteria are:
* clinical and/or molecular diagnosis of Multiple Osteochondromas;
* male and female subjects;
* age minors: 6-17 years at enrollment and adult age: 18-40 years at enrollment;
* collection of appropriate informed consent;
* ability to walk a linear path without aids;
* presence of multiple osteochondromas localized at lower limbs;
* ability to undergo all procedures required by the protocol.
For healthy cohort inclusion criteria are:
* absence of neuro-muskuloskeletal or other limb-limiting conditions in the lower limbs;
* male and female subjects;
* age minors: 6-17 years at enrollment and adult age: 18-40 years at enrollment;
* collection of appropriate informed consent;
* ability to undergo all procedures required by the protocol.
Exclusion Criteria:
* Persons who do not fit the inclusion criteria;
* Any reason which, in the opinion of the investigator, would result in the inability of the participant to comply with the protocol.
* BMI equal to or greater than 30.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional motor assessment
Timeframe: From subjects enrollment to the end of the assessment. Patients repeat these activities after 12 months from the first evaluation, while healthy subjects carry out the same activities of unhealthy population only once.
2
Anthropometric parameters assessment
Timeframe: From subjects enrollment to the end of the assessment. Patients repeat these activities after 12 months from the first evaluation, while healthy subjects carry out the same activities of unhealthy population only once.