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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2025-A02220-49 |
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| Name | Class |
|---|---|
| SAINBIOSE | UNKNOWN |
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Rheumatoid arthritis affects 0.5% of the population, often leading to foot deformities and pain that are difficult to treat. Management is based on controlling inflammation, adapting footwear and using custom-made insoles, all of which have proven effective. The aim of this research is to build a digital model of plantar pressures based on CT scans, in order to optimize orthopedic insoles. The study will analyze the gait of patients with and without standard insoles to identify mechanical criteria correlated with pain. The ultimate aim is to design optimized insoles, validated by a new gait analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D imaging (foot CT scan) | Other | foot CT scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gait analysis from 3D imaging (ENSENSO) | Other | gait analysis from 3D imaging (ENSENSO) on patients with bone geomtry 3D imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Construction of a patient-specific 3D model reproducing a gait cycle with or without an orthosis. | Bone geometry from 3D imaging (foot CT) combined with gait analysis (speed, step length, angular variation at the knee and ankle) from 3D imaging (ENSENSO) and accelerometers | Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of model parameters with pain | - Visual analogue scale (VAS) for pain in the right and left foot (0 = no pain; 10 = worst imaginable pain). | Day 1 |
| Correlation of model parameters with insole-wearing comfort. |
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Inclusion Criteria:
Exclusion Criteria:
Patients with a contraindication to a bone scan
Patients with neurological gait disorders that interfere with gait analysis
Exclude particularly protected persons:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hubert MAROTTE, MD PhD | Contact | (0)4 77 12 76 49 | +33 | hubert.marotte@chu-st-etienne.fr |
| Florence RANCON, CDP | Contact | (0)477829458 | +33 | florence.rancon@chu-st-etienne.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Saint-Etienne | Recruiting | Saint-Etienne | 42055 | France |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Visual analogue scale (VAS) for comfort in the right and left foot (0 = most comfortable; 10 = most uncomfortable).
| Day 1 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |