Femoral Component TKA: Extramedullary vs Conventional Intramedullary Guide (EMAX (L2055))
Positioning Femoral Component TKA Using an Extramedullary Guide: Comparison With Conventional Intramedullary Guide
The study wants to evaluate the performance of this EM guide in comparison to a traditional IM guide.
75 patients will be included in the extramedullary group (to be compared with a corresponding previous group of 75 patients treated with intramedullary guide).
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Descripción detallada
Total Knee Arthroplasty (TKA) is a widely performed surgical procedure aimed at relieving pain and restoring function in patients with advanced knee arthritis. The success of TKA is contingent upon precise implant positioning, particularly in relation to the femoral component. The femoral component's alignment significantly influences postoperative knee biomechanics, patient satisfaction, and long-term implant survival.
Conventional methods for femoral component positioning involve the use of intramedullary (IM) guides, which are inserted into the femoral canal to align the cutting block for bone preparation. While IM guides offer precise alignment, they can also lead to complications such as intraoperative fractures, fat embolism, activation of coagulation and excessive blood loss.
To address these limitations, extramedullary (EM) guides have emerged as an alternative option. EM guides are placed on the external surface of the femur without entering the medullary canal and avoiding complications that may occur reaming the canal.
In the recent past years, kinematic alignment (KA) has become widespread in use as a new technique for TKR that considers the patient's individual alignment and biomechanics. By restoring the pre-arthritic kinematic axes of the femur and tibia, KA aims to mimic the natural knee joint's function and movement.
In this study a specific EM guide - Anterior Cortex Stylus - is used to address the alignment of the femoral component in the context of a KA approach. The guide uses the anterior cortex of the distal femur as reference for cutting block positioning. The study aims to evaluate the performance of this EM guide in comparison to a traditional IM guide (used in previous group of patients).
This is an open, multi-centre, retro-prospective, observational, controlled study.
The primary aim is to evaluate whether the Anterior Cortex Stylus (in a retro-prospective collected series) is not inferior to the traditional intramedullary guide (previous group of patients) in term of positioning of the femoral component in TKA.
A total of 75 patients will be included in the extramedullary group (to be compared with a corresponding previous group of 75 patients treated with intramedullary guide). Both groups will be treated with a total knee arthroplasty using GMK Sphere (CE marked, class III) and a kinematic alignment approach.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Sara Zacchetti
- Número de teléfono: 0039 0283502227
- Correo electrónico: sara.zacchetti@grupposandonato.it
Copia de seguridad de contactos de estudio
- Nombre: Laura Mangiavini
- Número de teléfono: 0039 0283502227
Ubicaciones de estudio
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Milan, Italia, 20148
- Terminado
- Istituto Clinico San Siro
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Milan, Italia, 20157
- Reclutamiento
- IRCCS Ospedale Galeazzi-Sant'Ambrogio [coordinator]
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Contacto:
- Zacchetti
- Número de teléfono: 0039 0283502227
- Correo electrónico: sara.zacchetti@grupposandonato.it
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Torino, Italia, 10152
- Terminado
- Ospedale Cottolengo
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
The study shall include a total of 150 patients: 75 will be included in the extramedullary group, to be compared with a corresponding previous group of 75 patients treated with intramedullary guide. Patients meeting the inclusion criteria (mentioned below) will be recruited separately by each participating institution.
Patient enrolled in the retrospective analysis have been operated upon between January 2021 and September 2025.
Descripción
Inclusion Criteria:
- Male or female ≥ 18 years old
- Indication to primary TKA, for any diagnosis operated with EM or IM guides
- Signature of the informed consent (only for prospective cohort)
- Been operated upon between January 2021 and September 2025 (only for retrospective cohort)
Exclusion Criteria:
- Revision surgery of knee arthroplasty
- Patients with malignant diseases (at the time of surgery)
- Patients with proven or suspect infections (at the time of surgery)
- Pregnancy end/or lactating (auto declaration)
- Patient with known allergy to the specific metallic components of the prosthesis (at the time of surgery)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
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Extramedullary (EM) guides: Retroprospective + Prospective cohort
patients trated with extramedullary (EM) guides.
This cohort can be both Retroprospective and Prospective
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intramedullary (IM) guides: Retrospective cohort
patients trated with intramedullary (IM) guides.
This cohort will be only Retrospective
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Anterior Cortex Stylus
Periodo de tiempo: Radiographic angle at 3 moth post-op in the sagittal plane, between the anterior cortex of the distal femur and the femoral component and compare it in the group operated with Anterior Cortex Stylus versus the group operated with IM guide.
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Radiographic angle at 3 moth post-op of the femoral component in TKA in an Anterior Cortex Stylus (retro-prospective collected series) compared to intramedullary guide (previous group of patients)
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Radiographic angle at 3 moth post-op in the sagittal plane, between the anterior cortex of the distal femur and the femoral component and compare it in the group operated with Anterior Cortex Stylus versus the group operated with IM guide.
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Results across study centres
Periodo de tiempo: Compare the results in terms of radiographic sagittal angle between study centres at pre-op, surgery and 3 month post-op.
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Radiographic angles compared between the centres (at pre-op, surgery and 3 month post-op)
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Compare the results in terms of radiographic sagittal angle between study centres at pre-op, surgery and 3 month post-op.
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Adverse Events to determinate Instrument safety
Periodo de tiempo: During surgery
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Number of: adverse events, adverse device effects, serious adverse events and serious adverse device effects
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During surgery
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Corrado Sosio, Ospedale Galeazzi S.p.A.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
Otros números de identificación del estudio
- EMAX (L2055)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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.
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