- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02491047
Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study population include subjects with a classification of Gustilo I, II, IIIA or IIIB of tibial open fractures, assigned for surgical procedure, who meet eligibility criteria and provide signed informed consent.
Subjects will be randomized into either Study investigational arm or Study control arm, using a 1:1 ratio. Randomization will be stratified by Gustilo classification (I and II; IIIA ; IIIB).
Total duration of the study is expected to be approximately 32 months from first subject enrolled until last subject completed.
It is expected that each subject will be in the study for approximately 52 weeks
Subjects will be followed at the following time points:
- Immediately post index procedure
- During hospitalization
- Discharge visit
- 4 weeks and then monthly up to 24 weeks, 36 and at 52 weeks.
This is a single blind clinical trial. Subjects and their family members will be blinded to the treatment arms assignment. The study site personnel present at the baseline procedure as well as the physician performing the procedure will be trained not to disclose the treatment arm to the subject, his/her family, and to health care providers outside of the Orthopedic department.
An independent X-ray reading center assessing all subjects' images will be blinded to the treatment arms assignments, for the entire trial period. However, due to the radiographic appearance of the BonyPid-1000 as compared to SOC may differ, it is not entirely possible to blind the evaluating radiologists.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Cavite, Filipinas
- De La Salle HSI
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Manila City, Filipinas
- Philippines General Hospital
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Quezon City, Filipinas
- Philippine Orthopedic Center
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Be'er Sheva', Israel
- Soroka Medical Center
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Haifa, Israel, 31096
- Rambam Health Care Campus
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Jerusalem, Israel
- Hadassah University Hospital
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Tel Aviv, Israel, 64239
- The Tel Aviv Sourasky Medical Center
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Tel Hashomer, Israel, 5262100
- The Chaim Sheba Medical Center
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Merkaz
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Petah Tiqva, Merkaz, Israel
- Rabin Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male or non-pregnant female aged between 18 to 70 years of age.
- Female of childbearing potential should have a negative urine pregnancy test prior to index procedure Note: All female of childbearing potential must agree to use a highly effective method of contraception consistently and correctly for the duration of the study.
- Subjects with tibia open fractures of Gustilo grade I, II, IIIA or IIIB, who are assigned for surgery and are suitable for bone filler implantation, are eligible to participate in the study.
Single or multi-injured subjects who are hemodynamically and physiologically stable.
Note: A multi-injured subject is defined as one who sustains ≥2 injuries, each injury requiring hospitalization, independently of the presence of other injuries.
- Subjects who are able and willing to sign an informed consent form, prior to any protocol-specific procedures being performed and accept to comply with protocol requirements for the duration of the study. In specific cases, due to medical condition (e.g. a medical condition which necessitate an immediate medical treatment), a shortened consenting process may take place in accordance with local regulations.
Exclusion Criteria:
- Female who is pregnant or breastfeeding.
- Subjects with known current disseminated malignancies, active cancer or autoimmune diseases. Note: active cancer defined as - cancer for which therapeutic or palliative treatment is either ongoing at the time of enrolment or has stopped less than six (6) months before enrolment.
- Subjects with fractures due to known medical history of Osteoporosis.
- Subject with known medical history of Diabetes.
- Heavy smokers (a smoker with a daily cigarettes consumption of more than 20 pieces) in the last 6 months.
- Drug/alcohol abusers
- Acute infection in another sites/organs.
- Non-ambulating subjects prior to the trauma.
- More than 24 hours between injury and systemic antibiotic treatment initiation
- Subjects with bone fracture due to known medical history of metabolic bone diseases.
- Subjects with high velocity gunshot bone fractures.
- Subjects with major intra-articular fractures
- Subjects with hypersensitivity to doxycycline and or tetracycline family of drugs.
- Subjects treated with systemic doxycycline during the last 4 weeks prior to screening.
- Previous surgical intervention in the target tibia
- Subject with previous open fractures within one year in the target tibia
- Subjects currently receiving or have received an investigational product in the last 30 days and/or participate in another clinical trial.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: BonyPid-1000
Implantation of BonyPid-1000 medical device, constructed of bone filler coated with controlled release antibiotic formulation, concomitantly with standard of care treatment (SOC)
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BonyPid-1000 implantation concomitantly to standard of care (SOC) treatment
Standard of Care (SOC) treatment only
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Otro: Study control arm
Standard of care treatment (SOC) only
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Standard of Care (SOC) treatment only
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Safety: Deep Infection in the target fracture site
Periodo de tiempo: During the 4 weeks post index procedure
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Deep Infection in the target fracture site during the 4 weeks post index procedure.
The endpoint will be assessed by calculating the rate /percent per group.
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During the 4 weeks post index procedure
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Performance: Radiographic-assessed bone healing
Periodo de tiempo: During the 24-week follow-up period
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Radiographic-assessed bone healing during the 24-week follow-up period, based on independent blinded central radio-graphic evaluations of the target fracture's X-rays.
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During the 24-week follow-up period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Performance: Time to Radiographic-assessed bone healing
Periodo de tiempo: During the 24-week follow-up period
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Time to radiographic-assessed bone healing, based on independent blinded central radio-graphic evaluations of the target fracture's X-rays.
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During the 24-week follow-up period
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Shany Blum, Dr., PolyPid Ltd.
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 (Estimar)
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
- BonyPid-1000TM-103
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. .
Ensayos clínicos sobre Fracturas Tibiales
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CHU de ReimsTerminadoSeudoartrosis tibial sépticaFrancia
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Rush University Medical CenterInternational Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine...ReclutamientoDesgarro de menisco, tibialEstados Unidos
-
Austin V StoneTerminadoDesgarro del ligamento cruzado anterior | Lesiones del menisco tibial | Desgarros de menisco tibial | Menisco tibial, desgarradoEstados Unidos
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University of WinchesterHampshire Hospitals NHS Foundation TrustSuspendidoOsteotomía tibial alta con cuña de aloinjerto | Osteotomía tibial alta sin cuña de aloinjerto | Niveles de actividad física antes y después de la operaciónReino Unido
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Synthes GmbHTerminadoFractura Tibial Proximal Cerrada Schatzker I - VI | Fractura tibial proximal cerrada AO-OTA 41 | Fractura tibial proximal cerrada AO-OTA 42Corea, república de
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Zimmer BiometReclutamientoLesión de menisco | Desgarro de menisco, tibialEstados Unidos, Francia, Alemania, Japón
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University of Kansas Medical CenterTerminadoDesgarro de menisco, tibialEstados Unidos
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Fowler Kennedy Sport Medicine ClinicTerminadoOsteotomía tibial alta con cuña de aperturaCanadá
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University of California, San FranciscoReclutamientoLesión de menisco | Atrofia Muscular | Trastorno de menisco | Desgarro de menisco, tibial | Menisco, Tibial DesgarradoEstados Unidos
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Loma Linda UniversityTerminadoCirugía de Rodilla | Femoral distal | Tibial proximalEstados Unidos
Ensayos clínicos sobre BonyPid-1000
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PolyPid Ltd.MIS Implant Technologies, LtdTerminado
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HeadSense MedicalRigshospitalet, DenmarkDesconocidoHipertensión IntracranealDinamarca, Alemania, Países Bajos
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HeadSense MedicalUniversity of Maryland, College ParkDesconocidoHemorragia subaracnoidea | Vasoespasmo IntracranealEstados Unidos
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HeadSense MedicalSuspendidoCarrera | Lesiones Cerebrales | Neoplasias Cerebrales | Hipertensión Intracraneal | HidrocefaliaJapón
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HeadSense MedicalElisabeth-TweeSteden ZiekenhuisTerminadoLesiones Cerebrales | Hipertensión IntracranealPaíses Bajos