Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01317-32 | Registry Identifier | IDRCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective bi-centric study, which evaluate the evolution of RMI signal of transplant till 12 months after ligament plasty surgery.
As the primary objective, the study aims to define the post-operative timeframe needed to obtain an optimal quality of repair, especially in their restarting of sportive activities, by analysis of RMI signal and biomechanic features modifications.
As secondary objectives, the study aims to:
The eligible patients will be enrolled in the department of orthopaedic surgery of Ambroise Paré hospital, each patient will undergo a 12-months follow-up in the department of orthopaedic surgery in Armand Trousseau hospital for the elastography evaluations.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ligament plastic surgery ankle | Patient treated priorly by ligament plastic surgery of lateral ankle plane under arthroscopy |
| |
| Control group | Controlateral ankle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ligament plastic surgery | Procedure | Ligament plastic surgery of ankle under arthroscopy for recurrent instable ankle reason and failure of medical treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Classification of RMI signal | The classification of RMI signal will be defined as:
| At 3 months |
| Classification of RMI signal | The classification of RMI signal will be defined as:
| At 6 months |
| Classification of RMI signal | The classification of RMI signal will be defined as:
| At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior talofibular ligament measurement | anterior talofibular ligament measurement will be performed by RMI | At 3, 6 and 12 months |
| Calcaneofibular ligament measurement | calcaneofibular ligament measurement will be performed by RMI |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients underwent a ligament plastic surgery of lateral ankle plane under arthroscopy.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexandre HARDY, MD | Orthopaedic Surgery Department, Ambroise Paré hospital, APHP | Principal Investigator |
| Thomas BAUER, MD | Orthopaedic Surgery Department, Ambroise Paré hospital, APHP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Surgery Department, Ambroise Paré hospital, APHP | Boulogne-Billancourt | 92100 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
| RMI and ultrasound | Diagnostic Test | RMI examination at 3 months on operated ankle, and 3 CT scan examinations with elastography module will be performed at planned timeframes. |
|
| At 3, 6 and 12 months |
| Elastography | Elastography measurements: Young's Modulu | At 3, 6 and 12 months |
| Pain evaluation | By the American Orthopedic Foot and Ankle Score (AOFAS) to evaluate the pain. | At baseline and 3, 6 and 12 months |
| Pain evaluation | By the visual analog scale (VAS) to evaluate the pain. | At baseline and 3, 6 and 12 months |