Ligament Plastic Surgery
Conditions
Keywords
ligament injury, ligamentization
Brief summary
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: * study the correlation between the RMI signal of plasty and the Young's modulus; * study the evolution of RMI of plasty at M3, M6 and M12; * study the evolution of Young's modulus at M3, M6 and M12; * evaluate the reproductibility between 2 lector of RMI measurements; * evaluate the reproductibility between 2 lector of elastography measurements of LTFA; * evaluate the optimal delay of return to sport after ligament plasty surgery of ankle; * develope a score of type SNQ for ankle ligament plasty surgery; * evolution of AOFAS and EVA scores.
Detailed description
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.
Interventions
PROCEDURELigament plastic surgery
Ligament plastic surgery of ankle under arthroscopy for recurrent instable ankle reason and failure of medical treatment.
DIAGNOSTIC_TESTRMI and ultrasound
RMI examination at 3 months on operated ankle, and 3 CT scan examinations with elastography module will be performed at planned timeframes.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient treated priorly by ligament plastic surgery of lateral ankle plane under arthroscopy; * Affiliated to or covered by the French social security - welfare system in France; * Have provided written informed consent for the study; * Be \>/= 18 years of age on day of signing informed consent.
Exclusion criteria
* Patients who undergo iterative surgery or have history of contralateral surgery; * Patient under guardianship or curatorship; * Unable to understand the proposed study or provide written informed consent for the study; * Foreign patients under AME schema, a medical help from the state in France; * Pregnant or breastfeeding woman; * Patient refusal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Classification of RMI signal | At 3 months | The classification of RMI signal will be defined as: * frank hyposignal: stage 1; * intermediary signal (close to muscles of T2): stage 2; * moderate hypersignal (close to cartilage of T2): stage 3; * intensive hypersignal (close tointra-articular liquid of T2): stage 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anterior talofibular ligament measurement | At 3, 6 and 12 months | anterior talofibular ligament measurement will be performed by RMI |
| Calcaneofibular ligament measurement | At 3, 6 and 12 months | calcaneofibular ligament measurement will be performed by RMI |
| Elastography | At 3, 6 and 12 months | Elastography measurements: Young's Modulu |
| Pain evaluation | At baseline and 3, 6 and 12 months | By the American Orthopedic Foot and Ankle Score (AOFAS) to evaluate the pain. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAlexandre HARDY, MD
Orthopaedic Surgery Department, Ambroise Paré hospital, APHP
STUDY_DIRECTORThomas BAUER, MD
Orthopaedic Surgery Department, Ambroise Paré hospital, APHP
Outcome results
None listed