Outcomes of Surgical Treatment Using a Custom-made Device for Total Ankle and Talar Replacement in the Management of Severe Cases of Bone Loss or Bone Compromise: a Pilot Study.
On February 17th, 2021, the FDA officially approved the use of the first patient-specific 3D-printed talar implant for compassionate use. This is a patient-specific talar spacer designed to completely replace the talus for the treatment of talar avascular necrosis. The implant represents an alternative to other surgical procedures that allows joint preservation.
Recently, at the First Clinic of the Rizzoli Orthopaedic Institute, a prosthetic device has been developed that combines the tibial and meniscal components of a FAR-type ankle prosthesis (Adler Ortho) with a total talus replacement implant. Since the device is patient-specific and implanted using custom-made cutting guides, it reduces surgical invasiveness on surrounding bone structures as well as on ligamentous and tendinous structures, thereby preserving ankle function as much as possible.
The customization is based on a next-generation prosthetic model produced using additive manufacturing technology and featuring hypoallergenic properties, as it is made of a titanium alloy and treated with a nitriding process.
The aim of this study is therefore to evaluate the outcomes of this prosthetic device over time.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Antonio Mazzotti, PhD MD
- Número de teléfono: +39 349 879 8863
- Correo electrónico: antonio.mazzotti@ior.it
Ubicaciones de estudio
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Bologna, Italia
- Reclutamiento
- Istituto Ortopedico Rizzoli
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Contacto:
- cesare Faldini, MD
- Número de teléfono: 051-6366669
- Correo electrónico: cesare.faldini@ior.it
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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
Patients with degenerative pathology of the tibiotalar joint associated with significant bone loss or talar bone compromise, for whom further diagnostic evaluation using CT imaging is required to determine a potential surgical indication, will be included in this pilot study. In the case of confirmation of the indication for total ankle replacement with total talar substitution, patients will undergo a CT scan of the contralateral ankle for implant design (as per standard clinical practice for the development of patient-specific implants) and surgical planning. Following surgery, patients will be evaluated at subsequent follow-up visits according to routine clinical practice.
All study procedures will be conducted at Clinic I of the Rizzoli Orthopaedic Institute (patient selection and enrolment, and diagnostic imaging).
The study population consists of patients aged between 35 and 75 years affected by degenerative disease of the tibiotalar joint associated with severe bone loss or tala
Descripción
**INCLUSION CRITERIA:**
- Male or female patients aged between 35 and 75 years.
- Pathology of the tibiotalar joint requiring surgical intervention with prosthetic replacement.
- Severe cases of bone loss or talar bone compromise.
- Customisation performed at the Rizzoli Orthopaedic Institute.
- Signed informed consent for participation in the study.
- Patients must be prepared and motivated to comply with preoperative and postoperative investigations, rehabilitation protocols, follow-up schedules, and study questionnaires.
**EXCLUSION CRITERIA:**
- Patients unable to understand or provide informed consent.
- Pregnant women.
- Body mass index (BMI) > 40.
- Refusal to sign the informed consent form for study participation.
- Substance abuse or psychological disorders that may interfere with adherence to rehabilitation and postoperative assessment protocols.
- Known hypersensitivity to device materials.
- Active or suspected latent infection in or around the affected ankle joint.
- Previous orthopaedic surgery on the lower limbs within the last year, or planned orthopaedic surgery within one year (excluding ankle replacement).
- Presence of neuromuscular or neurosensory deficits limiting the ability to assess device safety and efficacy.
- Diagnosis of systemic disease (e.g., systemic lupus erythematosus) or metabolic disorder (e.g., Paget's disease of bone) leading to progressive bone deterioration.
- Immunosuppression or excessive steroid therapy beyond physiological requirements (e.g., >30 days).
- Pregnant and/or fertile women.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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To evaluate the survival of the FAR implant in a cohort of patients treated at the Orthopaedic and Traumatology Clinic I of the Rizzoli Orthopaedic Institute, with follow-up at 1, 3, 6, 12, 24, and 36 months.
Periodo de tiempo: february 2022 - march 2028
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february 2022 - march 2028
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Objective and subjective clinical and radiographic evaluation of the implant To assess ankle joint function using radiographic (X-ray) imaging
Periodo de tiempo: 36 months
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Study procedures include: Training of surgeons and research staff on the new procedure. Acquisition of a patient list based on radiographic criteria obtained during routine outpatient procedures. Patient screening period. Assessment of patient eligibility for study inclusion. Functional and clinical evaluation of the prosthesis in collaboration with the Orthopaedic and Traumatology Clinic I (Rizzoli Orthopaedic Institute). Patient enrolment and informed consent collection. Preoperative procedures, including acquisition of diagnostic imaging (weight-bearing AP and lateral X-rays, clinical scores, preoperative CT scan). FFor each patient, a computer-based virtual prosthetic implantation will be performed, and a patient-specific talar component will be manufactured for total bone replacement. Surgical procedure involving total ankle replacement using the patient-specific prosthetic device with total talar substitution. |
36 months
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To evaluate clinical parameters using: The American Orthopaedic Foot and Ankle Society (AOFAS) score The Manch
Periodo de tiempo: 36 months
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36 months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- ASTot
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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