Effects of Femoral Canal Opening Technique on Biomarkers
12 de junio de 2026 actualizado por: Vedran Kovacic, University of Split, School of Medicine
Effects of Femoral Canal Opening Technique on Inflammation, Coagulation, Organ Dysfunction, and Bone Metabolism
This single-centre prospective randomized study consisted of 60 participants (50 women) with a mean age of 80.33 ± 11.13 years, randomly allocated to either manual medullary canal opening (n = 30) or mechanical drilling of the canal (n = 30). Outcomes were assessed preoperatively and postoperatively during a 72-hour follow-up period. This study had a prospective design. Outcomes were assessed preoperative and during the follow-up period to 72 hours after surgery. During follow-up, all patients underwent laboratory testing. Blood samples were collected 2 hours preoperatively and 72 hours postoperatively in order to determine blood concentrations of leukocytes, erythrocytes, platelets (×10⁹/L), haemoglobin (g/L), D-dimers (IU/L), prothrombin time, international normalized ratio (INR), activated partial thromboplastin time (aPTT) (s), aPTT ratio, fibrinogen (g/L), creatinine (μmol/L), N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/mL), C-reactive protein (CRP) (mg/L), glucose, urea, sodium, potassium, chloride, calcium, and phosphorus (mmol/L), as well as bone metabolism markers: total procollagen type 1 N-terminal propeptide (tP1NP) (µg/L), N-min osteocalcin (N-mOST) (µg/L), C-terminal telopeptide of type I collagen (β-CTX) (ng/mL), and bone-specific alkaline phosphatase (BAP) (µg/L).
The investigatoras compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours. In addition, the investigators analysed the dynamics (baseline vs. 72 hours) of outcome measures between the two study groups.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Split, Croacia
- University Hospital of Split, 21000 Croatia
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- adult patients (aged > 18 years) admitted to the Department of Surgery, Orthopaedics and Traumatology Division, University Hospital Centre Split, who, during the observation period, sustained a pertrochanteric femoral fracture following a fall and were scheduled for surgery within 3 days after injury.
Exclusion Criteria:
- included patients with acute or chronic inflammatory conditions
- polytraumatic patients
- patients with disseminated malignant disease
- acute organ failure
- patients on vitamin D and calcium supplementation
- patients receiving corticosteroids, cytostatics, anticoagulations, or other medications that could influence the observed parameters.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: manual medullary canal opening
Tthe medullary canal was opened under fluoroscopic guidance using a cannulated curved awl (14.0/3.2 mm).
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All participants were operated on according to the same protocol, using the same type of procedure on a traction table, with prior fracture reduction under fluoroscopic (X-ray) guidance.
All patients had the same type of fracture (pertrochanteric femoral fracture), and intramedullary osteosynthesis was performed using a ⌀ 9.0 mm, 340 mm Proximal Femoral Nail Antirotation (PFNA) (Synthes GmbH, Oberdorf, Switzerland).
In the first group, the medullary canal was opened under fluoroscopic guidance using a cannulated curved awl (14.0/3.2 mm).
In the second group, the medullary canal was opened under fluoroscopic guidance using a battery-powered surgical drill equipped with a cannulated drill bit (13.0 mm diameter, 290 mm length) (Synthes GmbH, Oberdorf, Switzerland).
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Otro: mechanical drilling of the canal
The medullary canal was opened under fluoroscopic guidance using a battery-powered surgical drill equipped with a cannulated drill bit (13.0 mm diameter, 290 mm length)
|
All participants were operated on according to the same protocol, using the same type of procedure on a traction table, with prior fracture reduction under fluoroscopic (X-ray) guidance.
All patients had the same type of fracture (pertrochanteric femoral fracture), and intramedullary osteosynthesis was performed using a ⌀ 9.0 mm, 340 mm Proximal Femoral Nail Antirotation (PFNA) (Synthes GmbH, Oberdorf, Switzerland).
In the first group, the medullary canal was opened under fluoroscopic guidance using a cannulated curved awl (14.0/3.2 mm).
In the second group, the medullary canal was opened under fluoroscopic guidance using a battery-powered surgical drill equipped with a cannulated drill bit (13.0 mm diameter, 290 mm length) (Synthes GmbH, Oberdorf, Switzerland).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The main marker od inflamation
Periodo de tiempo: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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CRP (mg/L)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Blood cells count
Periodo de tiempo: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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blood concentrations of leukocytes, erythrocytes, platelets (×10⁹/L)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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D-dimers concetration
Periodo de tiempo: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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D-dimers (IU/L)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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Coagulation: prothrombin time with international normalized ratio (INR)
Periodo de tiempo: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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prothrombin time (seconds)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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Coagulation: activated partial thromboplastin time (aPTT)
Periodo de tiempo: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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activated partial thromboplastin time (aPTT) (seconds)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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Fibrinogen concentration
Periodo de tiempo: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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fibrinogen (g/L)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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Creatinine concentration
Periodo de tiempo: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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creatinine (μmol/L)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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Concetration of N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Periodo de tiempo: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/mL)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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Plasma biochemistry
Periodo de tiempo: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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glucose, urea, sodium, potassium, chloride, calcium, and phosphorus (mmol/L)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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Bone metabolism markers
Periodo de tiempo: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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total procollagen type 1 N-terminal propeptide (tP1NP) (µg/L), N-min osteocalcin (N-mOST) (µg/L), bone-specific alkaline phosphatase (BAP) (µg/L)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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Bone metabolism marker C-terminal telopeptide of type I collagen (β-CTX)
Periodo de tiempo: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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C-terminal telopeptide of type I collagen (β-CTX) (ng/mL)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Vedran Kovacic, University of Split, School of Medicine
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de marzo de 2025
Finalización primaria (Actual)
30 de noviembre de 2025
Finalización del estudio (Actual)
30 de noviembre de 2025
Fechas de registro del estudio
Enviado por primera vez
31 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2026
Publicado por primera vez (Actual)
15 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 520-03/25-01/65
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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