Effects of Femoral Canal Opening Technique on Biomarkers
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Split、克罗地亚
- University Hospital of Split, 21000 Croatia
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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其他: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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其他: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The main marker od inflamation
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Blood cells count
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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)
大体时间: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
大体时间: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
大体时间: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)
大体时间: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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合作者和调查者
调查人员
- 首席研究员:Vedran Kovacic、University of Split, School of Medicine
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 520-03/25-01/65
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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