Effects of Femoral Canal Opening Technique on Biomarkers
12 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Split, Croácia
- University Hospital of Split, 21000 Croatia
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: 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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Outro: 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)
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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The main marker od inflamation
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Blood cells count
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Vedran Kovacic, University of Split, School of Medicine
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de março de 2025
Conclusão Primária (Real)
30 de novembro de 2025
Conclusão do estudo (Real)
30 de novembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
31 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de junho de 2026
Primeira postagem (Real)
15 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 520-03/25-01/65
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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