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Prospective, single-center, randomized interventional clinical trial of tourniquet use in hallux valgus surgery. Patients will be their own controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm with tourniquet | Active Comparator | The surgeon will use the tourniquet as usual. |
|
| Arm without tourniquet | Experimental | The surgeon will operate without the aid of a tourniquet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tourniquet | Other | peroperation tourniquet |
| |
| No tourniquet |
| Measure | Description | Time Frame |
|---|---|---|
| Average pain in the first week after surgery | Comparison between the 2 groups of the average VAS over the first week following surgery, from 0 to 100 points, 0 being the value where the patient has no pain and 100 the maximum pain value. | first week after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Edema | Measurement of foot edema at D10 during the consultation, taking the difference in cm between the postoperative measurement and the preoperative measurement. | Day 10 after surgery |
| Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cecile Spirito | Contact | 0033467413400 | cecile.spirito@capsante.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique St Jean Sud de France | Recruiting | Saint-Jean-de-Védas | 34430 | France |
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| ID | Term |
|---|---|
| D006215 | Hallux Valgus |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014111 | Tourniquets |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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The patient will be his or her own control, with one foot operated with a tourniquet and the other without.
Once the patient has been included, the surgeon will open the randomization envelope to determine which foot will receive the tourniquet. He will operate on the left foot first.
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| Other |
no tourniquet during surgery |
|
Occurrence of complications specific to tourniquet use as a percentage in each arm.
| first week after surgery |