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the recruitment rate is far too low despite an 18-month extension of the inclusion period
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| Name | Class |
|---|---|
| Euraxi Pharma | INDUSTRY |
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Interventional, comparative, randomized, controlled study versus standard treatment, in 3 parallel groups, monocentric, aiming to demonstrate the superiority of preoperative cryoneurolysis versus no procedure, in patients operated on for knee arthroplasty and receiving standard analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cryoneurolysis of the saphenous nerve | Experimental | A cryoneurolysis of the saphenous nerve will be performed between 7 days and 5 days before the knee arthroplasty |
|
| cryoneurolysis of geniculate nerves | Experimental | A cryoneurolysis of geniculate nerves will be performed between 7 days and 5 days before the knee arthroplasty |
|
| control | Placebo Comparator | No cryoneurolysis will be performed before the knee arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard pain relievers | Drug | Knee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| 90 ° flexion pain 2 days after the arthroscopy | Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| 90 ° flexion pain 1 day after the arthroscopy | Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm | 1 day |
| 90 ° flexion pain 7 days after the arthroscopy | Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital privé Paul d'Egine | Champigny-sur-Marne | 94500 | France |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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|
| 7 days |
| 90 ° flexion pain 30 days after the arthroscopy | Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm | 30 days |
| 90 ° flexion pain 90 days after the arthroscopy | Evaluation of the knee pain at 90° flexion with a visual analogic scale of 100 mm | 90 days |
| pain at rest at Day 1 | Knee pain after intervention with a visual analogic scale of 100 mm | 1 day |
| pain at rest at Day 2 | Knee pain after intervention with a visual analogic scale of 100 mm | 2 days |
| pain at rest at Day 7 | Knee pain after intervention with a visual analogic scale of 100 mm | 7 days |
| pain at rest at Day 30 | Knee pain after intervention with a visual analogic scale of 100 mm | 30 days |
| pain at rest at Day 90 | Knee pain after intervention with a visual analogic scale of 100 mm | 90 days |