- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07661615
Arthroscopic or Open Evaluation of Posterolateral Instability Associated With Lateral Epicondylitis (INPOLA)
The elbow is a complex joint made up of three bones, three joints, and three ligaments. Repeated microtraumas can lead to ligament injuries and instability, tendon damage, or degenerative processes affecting the bones, cartilage, and bursae. As a result, elbow pain is not uncommon, and diagnosing the underlying problem is not always easy. One reason for this is the complex anatomy packed into a small space. Many disorders produce overlapping symptoms, making them hard to tell apart. In this context, diagnostic confusion isn't unusual. So, posterolateral rotatory instability of the elbow has symptoms similar to those of lateral epicondylitis, the main diagnosis for a painful elbow, but the way it's treated is different.
However, a wrong diagnosis can be linked to treatment failure risks that might put the patient in a therapeutic, social, or work/sports dead end. An accurate and early diagnosis could allow for quickly setting up a treatment strategy suited to the condition.
The relationship between posterolateral elbow instability and lateral epicondylitis has been little studied in the literature. This project is based on the hypothesis that lateral epicondylitis is often associated with posterolateral instability. Checking the lateral collateral ligament of the elbow during scheduled surgery to treat lateral epicondylitis, either arthroscopically or openly, could help better assess this relationship.
The main aim of this study is to figure out the percentage of patients with posterolateral elbow instability, diagnosed either through arthroscopy or open surgery, among those with lateral epicondylitis who are up for surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Lyon, Francia, 69008
- Hôpital privé Jean Mermoz
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Villeurbanne, Francia, 69100
- Institut chirurgical de la Main et du Membre Supérieur
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patient, male or female, over 18 years old.
- Patient who has had pain in the lateral compartment of the elbow and has received well-managed medical treatment (splint, injection) for at least 6 months.
- Patient scheduled for planned elbow surgery, either arthroscopic or open.
- Patient with tenderness in the lateral epicondyle area.
- Patient experiencing pain at the lateral epicondyle during resisted wrist extension.
- Patient enrolled in or receiving benefits from a social security program.
- Patient has been informed and does not object to this research. ...
Exclusion Criteria:
- Patient with a history of elbow surgery, dislocation, or fracture.
- Patient with elbow deformities.
- Patient with synovial plica.
- Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision.
- Pregnant, breastfeeding, or laboring woman.
- Patient hospitalized without consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Patient scheduled for elective elbow surgery, either arthroscopic or open.
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Elbow surgery : arthroscopic or open.
Difference in QuickDash scores between the preoperative and postoperative visit; score from 0 to 100 (0, no disability to 100, most severe disability).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of patients with posterolateral elbow instability.
Periodo de tiempo: one day
|
This instability is diagnosed during scheduled surgery, either arthroscopically or with an open procedure, by the presence of a lateral collateral ligament injury.
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one day
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2020-A01931-38
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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