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| Name | Class |
|---|---|
| Vivactis M2Research | INDUSTRY |
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Observational, ambispective, longitudinal, monocentric, open cohort study of a population of adult patients operated on for ACL reconstruction and receiving postoperative follow-up.
On a large population of adult patients operated on for anterior cruciate ligament reconstruction and followed over a 12-month period under standard medical practice conditions.
Primary objective: to investigate, six months after surgery, the presence of patellofemoral pain and to evaluate the factors predictive of the occurrence of such pain.
Secondary objectives:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anterior cruciate ligament reconstruction | Procedure | anterior cruciate ligament reconstruction |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior patellofemoral pain | The presence of anterior patellofemoral pain at 6 months post-op was the primary endpoint of the study. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Returning to sport | Returning to sport after anterior cruciate ligament (ACL) reconstruction requires optimal physical and psychological recovery. The Anterior Cruciate Ligament-Return-to-Sport after Injury (ACL-RSI) scale is the first tool to assess this psychological dimension. It consists of 12 questions with answers rated from 0 to 10 on a simple numerical scale | Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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The inclusion population will be described according to all patient characteristics.
Quantitative variables will be described by their number, mean, standard deviation, median, extreme values and missing data. Qualitative variables will be described by their number, percentage and missing data. Bilateral 95% confidence intervals will be provided if the criterion is considered relevant.
The population will be described overall and in each group.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de la Sauvegarde | Lyon | 69009 | France |
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| ID | Term |
|---|---|
| D059549 | Anterior Cruciate Ligament Reconstruction |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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| Returning to sport | Returning to sport after anterior cruciate ligament (ACL) reconstruction requires optimal physical and psychological recovery. The Anterior Cruciate Ligament-Return-to-Sport after Injury (ACL-RSI) scale is the first tool to assess this psychological dimension. It consists of 12 questions with answers rated from 0 to 10 on a simple numerical scale | Month 12 |
| Subjective knee assessment | The International Knee Documentation Committee Subjective Knee Form is a self-administered questionnaire divided into three sections (symptoms, sports activities, function). Its score ranges from 0 (worst situation) to 100 (no restrictions on daily activities and sports, and no symptoms). | Month 6 |
| Subjective knee assessment | The International Knee Documentation Committee Subjective Knee Form is a self-administered questionnaire divided into three sections (symptoms, sports activities, function). Its score ranges from 0 (worst situation) to 100 (no restrictions on daily activities and sports, and no symptoms). | Month 12 |
| Subjective symptoms assessment | The Kujala Anterior Knee Pain Scale (Kujala AKPS) is a questionnaire used to assess subjective symptoms such as functional limitations and anterior knee pain. It comprises 13 items: 6 concerning the patient's activities (walking, running, jumping, stairs, squatting, prolonged sitting), 7 concerning the patient's symptoms (lameness, unloading, swelling, maltracking of the patella, muscle atrophy, flexion deficit). The score ranges from 0 (highly symptomatic patient) to 100 (asymptomatic patient). Patients with a score of 70 are considered to have moderate disability. | Month 6 |
| Subjective symptoms assessment | The Kujala Anterior Knee Pain Scale (Kujala AKPS) is a questionnaire used to assess subjective symptoms such as functional limitations and anterior knee pain. It comprises 13 items: 6 concerning the patient's activities (walking, running, jumping, stairs, squatting, prolonged sitting), 7 concerning the patient's symptoms (lameness, unloading, swelling, maltracking of the patella, muscle atrophy, flexion deficit). The score ranges from 0 (highly symptomatic patient) to 100 (asymptomatic patient). Patients with a score of 70 are considered to have moderate disability. | Month 12 |
| Sporting and occupational physical activity assessment | The Tegner activity-level scale is a scale of sporting and occupational physical activity: from 0 (occupational disability due to knee) to 10 (competitive sport such as soccer or rugby at national or international level). The scale was originally developed to measure activity following knee injuries, and validated for monitoring ACL ruptures following ligamentoplasty. | Month 6 |
| Sporting and occupational physical activity assessment | The Tegner activity-level scale is a scale of sporting and occupational physical activity: from 0 (occupational disability due to knee) to 10 (competitive sport such as soccer or rugby at national or international level). The scale was originally developed to measure activity following knee injuries, and validated for monitoring ACL ruptures following ligamentoplasty. | Month 12 |