Extension Block Pinning vs Conservative Treatment for Mallet Finger Fractures (PO-EBPT)
Pin Orthosis Extension Block Pinning Versus Conservative Treatment for Doyle Type 4B Mallet Fractures
Mallet finger fractures are injuries affecting the tip of the finger and can be treated either with splinting or surgery. However, there is no clear agreement on which treatment provides better outcomes for certain types of these fractures.
In this study, patients with mallet finger fractures were randomly assigned to receive either surgical treatment using a pin-orthosis extension-block pinning technique or conservative treatment with splint immobilization. Patients were followed at regular intervals, and outcomes such as finger movement, function, bone healing, and complications were evaluated over time.
The purpose of this study is to compare these two treatment approaches and determine which one leads to better clinical and functional outcomes.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Mallet finger fractures, particularly those involving a significant portion of the distal interphalangeal joint articular surface, present a therapeutic challenge, and there is no consensus regarding the optimal treatment strategy. Both conservative management with splinting and various surgical techniques have been described in the literature.
This randomized controlled trial was designed to compare the clinical and radiographic outcomes of the pin-orthosis extension-block pinning technique and conventional conservative treatment in patients with mallet finger fractures. Patients were randomly assigned to either surgical or conservative treatment groups and followed at regular intervals.
Clinical and functional outcomes were assessed throughout the follow-up period to evaluate the effectiveness and safety of both treatment approaches."
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Sultangazi
-
Istanbul, Sultangazi, Turquía (Türkiye), 34265
- Haseki Training and Research Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age between 18 and 65 years
- Acute mallet fracture (≤ 3 weeks from injury)
- Fracture fragment involving 20-50% of the distal interphalangeal (DIP) joint articular surface
Exclusion Criteria:
- Open fractures
- Chronic mallet fractures (> 3 weeks from injury)
- Fracture fragment involving more than 50% of the DIP joint articular surface
- Open physes
- Inability to complete 12-month follow-up
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Surgical Treatment (PO-EBPT)
Participants in this group underwent surgical treatment using the pin-orthosis extension-block pinning technique.
|
The pin-orthosis extension-block pinning technique was performed under appropriate anesthesia.
A Kirschner wire was used to block extension at the distal interphalangeal joint and stabilize the fracture fragment, followed by immobilization with an orthosis.
The fixation was maintained for a defined period, and patients were followed according to the study protocol.
|
|
Comparador activo: Conservative Treatment (Splinting)
Participants in this group received conservative treatment with splint immobilization of the distal interphalangeal joint.
|
Conservative treatment consisted of continuous splint immobilization of the distal interphalangeal joint in extension.
Patients were instructed to maintain uninterrupted splint use for the recommended duration with regular follow-up visits to monitor compliance and clinical progress.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Distal Interphalangeal Joint Extension Lag
Periodo de tiempo: 12 months
|
Degree of extension lag at the distal interphalangeal joint measured using a goniometer.
|
12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Distal Interphalangeal Joint Range of Motion
Periodo de tiempo: Up to 12 months (assessed at 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months)
|
Range of motion of the distal interphalangeal joint measured in degrees.
|
Up to 12 months (assessed at 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months)
|
|
Functional Outcome According to Crawford Criteria
Periodo de tiempo: 12 months
|
Functional outcome assessed using the Crawford classification system.
|
12 months
|
|
Fracture Union
Periodo de tiempo: Up to 12 months (assessed at 6 weeks, 3 months, 6 months, and 12 months)
|
Radiographic evidence of fracture healing assessed during follow-up.
|
Up to 12 months (assessed at 6 weeks, 3 months, 6 months, and 12 months)
|
|
Complication Rate
Periodo de tiempo: Up to 12 months
|
Incidence of treatment-related complications observed during the study period.
|
Up to 12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kemal A Col, Doctor, Haseki Training and Research Hospital
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 39-2022
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .