Characterization of Multiple Osteochondromas Disorder

Misure di funzionalità e deformità Dell'Apparato Muscolo-scheletrico Come "Biomarkers" Per il Trattamento di Malattie Ortopediche/Accessible Measurements of Mobility and Deformity as Biomarkers for Orthopaedic Treatments

This study is testing how hereditary multiple osteochondromas affects people of all ages to improve treatment timing and quality of life, while also trying out new ways to measure joint movement and bone shape.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 6 Years to 40 Years
• Sex: All
• Sponsor: Istituto Ortopedico Rizzoli (other)
• Locations: 1 site (Bologna)
• Trial ID: NCT06703736 on ClinicalTrials.gov

What this trial studies

This study aims to characterize the functional and morphological changes associated with hereditary multiple osteochondromas in both pediatric and adult populations. It will collect anthropometric and functional data to assess the disease holistically, which may inform the timing of surgical interventions and enhance patient quality of life. Additionally, the study seeks to validate new tools for measuring joint mobility and bone deformity, designed for ease of use by patients and minimally trained operators. The ultimate goal is to evaluate the quality of life and balance perception in affected individuals.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 6-40 years with a clinical or molecular diagnosis of multiple osteochondromas, particularly those with lesions in the lower limbs.

Not a fit: Patients outside the specified age range or those without multiple osteochondromas or other significant limb-limiting conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved assessment and management strategies for patients with hereditary multiple osteochondromas, enhancing their quality of life.

How similar studies have performed: While there is limited literature on the instrumental characterization of osteochondromas, the holistic approach of this study is novel and may pave the way for future advancements in understanding this condition.

Eligibility criteria

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.

Where this trial is running

Bologna

• IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (RECRUITING)

Study contacts

• Study coordinator: Paolo Caravaggi, PhD, Engineer

Conditions: Hereditary Multiple Osteochondromas, Multiple osteochondromas, Functional limitation, Skeletal deformity, Gait analysis, IMU, Anthropometry, 3D scanning