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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 40
Healthy Volunteers: t
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⁃ 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.

Locations
Other Locations
Italy
IRCCS Istituto Ortopedico Rizzoli
RECRUITING
Bologna
Contact Information
Primary
Paolo Caravaggi, PhD, Engineer
paolo.caravaggi@ior.it
00390516366500
Backup
marina mordenti, PhD
marina.mordenti@ior.it
00390516366500
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2026-06
Participants
Target number of participants: 60
Treatments
Multiple osteochondromas patients
The cohort is composed of patients suffering from hereditary multiple osteochondromas (HMO) and it contains 30 subjects: 15 minors (6-17 years) and 15 adults (18-40 years). The inclusion criteria of HMO cohort are: clinical and/or molecular diagnosis of Multiple Osteochondromas; male and female subjects; collection of appropriate informed consent; ability to walk a linear path without aids; presence of OM localized at lower limbs; ability to undergo all procedures required by the protocol. Are excluded from the cohort subjects with body mass index (BMI) equal to or greater than 30.
Healthy subjects
Healthy subjects are control population, equivalent in gender and age to the investigated population. The cohort is composed of 30 subjects: 15 minors (6-17 years) and 15 adults (18-40 years).The inclusion criteria of healthy cohort are: absence of neuro-muskuloskeletal or other limb-limiting conditions in the lower limbs; male and female subjects; collection of appropriate informed consent; ability to undergo all procedures required by the protocol. Are excluded from the cohort subjects with body mass index (BMI) equal to or greater than 30.
Sponsors
Leads: Istituto Ortopedico Rizzoli

This content was sourced from clinicaltrials.gov