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Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to patellofemoral malalignment and soft tissue overload.
A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the outcome of morpho-specific foot orthoses in a prospective randomized study.
The purpose of this prospective randomized study is to compare clinical outcomes in daily living and in sports activities, between morpho-specific and placebo foot orthoses.
Morpho-specific foot orthoses are designed according to the patient's morphotype. They are intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to correct abnormal overload during patellofemoral tracking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morpho-specific foot orthoses | Experimental | Morpho-specific thermo-molded foot orthoses are designed according to the patient's morphotype. Orthoses are custom-molded from different materials such as BIOFLUX resin, Covercuir MF, EVA300/60, EVA400/70, PE255/55, ABSORB Dur and CAPITON PU. |
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| Placebo foot orthoses | Placebo Comparator | The placebo foot orthoses will be made with the same principle of molding and with the same materials as for the experimental group. The only difference is that they involve no active corrective insert element : they will be made without morphotype correction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foot orthoses | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Item Pain of the KOOS Score | Twice : at inclusion and at 10 weeks follow-up with feet orthoses |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS Score (items Symptoms, Activities of daily living, Sport and recreation function, Knee-related quality of life) | Twice : at inclusion and at 10 weeks follow-up with feet orthoses | |
| Kujala Score | Twice : at inclusion and at 10 weeks follow-up with feet orthoses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yann DIESINGER, MD | Contact | 388552310 | 0033 | yann.diesinger@chru-strasbourg.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet libéral - 12, rue du Puits | Recruiting | Haguenau | 67500 | France |
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| ID | Term |
|---|---|
| D046788 | Patellofemoral Pain Syndrome |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D061826 | Foot Orthoses |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Pain level | Visual Analog Scale (VAS) | Twice : at inclusion and at 10 weeks follow-up with feet orthoses |
| Service de Chirurgie Orthopédique - Hôpital CCOM - Hôpitaux Universitaires de Strasbourg | Recruiting | Illkirch-Graffenstaden | 67400 | France |
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| Cabinet libéral - 50, avenue des Vosges | Recruiting | Strasbourg | 67000 | France |
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