Effects of Femoral Canal Opening Technique on Biomarkers
12 июня 2026 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
60
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Split, Хорватия
- University Hospital of Split, 21000 Croatia
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Диагностика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Другой: 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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Другой: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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The main marker od inflamation
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Blood cells count
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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.
|
|
Coagulation: activated partial thromboplastin time (aPTT)
Временное ограничение: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
|
activated partial thromboplastin time (aPTT) (seconds)
|
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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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.
|
|
Bone metabolism markers
Временное ограничение: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
|
total procollagen type 1 N-terminal propeptide (tP1NP) (µg/L), N-min osteocalcin (N-mOST) (µg/L), bone-specific alkaline phosphatase (BAP) (µg/L)
|
The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
|
|
Bone metabolism marker C-terminal telopeptide of type I collagen (β-CTX)
Временное ограничение: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
|
C-terminal telopeptide of type I collagen (β-CTX) (ng/mL)
|
The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Vedran Kovacic, University of Split, School of Medicine
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 марта 2025 г.
Первичное завершение (Действительный)
30 ноября 2025 г.
Завершение исследования (Действительный)
30 ноября 2025 г.
Даты регистрации исследования
Первый отправленный
31 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
12 июня 2026 г.
Первый опубликованный (Действительный)
15 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
15 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
12 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 520-03/25-01/65
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .