Not provided
Not provided
Not provided
Not provided
The sponsor, in consultation with the principal investigator, decided to stop the study prematurely (given the small number of eligible patients).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Euraxi Pharma | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to evaluate the proportion of patients after rupture of the anterior cruciate ligament (ACL) of the knee, who will have functional or surgical management (PEC) in 1st intention, after having received appropriate information.
As part of this study, patients will be followed for 1 year with regular functional and quality of life assessments (45 days after inclusion, 3, 6, 9 and 12 months after the start of surgical or non-surgical management). Patients who, during follow-up, will have been redirected towards surgery by the doctor (in the event of functional instability) or who will have chosen to finally move towards surgical PEC, will also be followed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type of management, surgical or functional, after rupture of the anterior cruciate ligament | Other | Patients will choose the type of management, surgical or functional, after rupture of the anterior cruciate ligament. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional or surgical management in 1st intention | Procedure | Proportion of patients after rupture of the anterior cruciate ligament of the knee, who will have functional or surgical management in 1st intention |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients operated at 45 days | Rate of patients in the total population who underwent surgery 45 days after anterior cruciate ligament rupture | 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who persist in the choice of non-surgical | To assess the proportion of patients who persist in the choice of non-surgical management at 3, 6, 9 and 12 months (in patients who had initial non-surgical management). | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de la Sauvegarde | Lyon | 69009 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, longitudinal, open, non-comparative (single arm), monocentric study.
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000085542 | Functional Status |
| ID | Term |
|---|---|
| D000203 | Activities of Daily Living |
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided