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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
60
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).
University Hospital of Split, 21000 Croatia
Split, Croatia
The main marker od inflamation
CRP (mg/L)
Time frame: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
Blood cells count
blood concentrations of leukocytes, erythrocytes, platelets (×10⁹/L)
Time frame: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
D-dimers concetration
D-dimers (IU/L)
Time frame: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
Coagulation: prothrombin time with international normalized ratio (INR)
prothrombin time (seconds)
Time frame: 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)
activated partial thromboplastin time (aPTT) (seconds)
Time frame: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
Fibrinogen concentration
fibrinogen (g/L)
Time frame: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
Creatinine concentration
creatinine (μmol/L)
Time frame: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
Concetration of N-terminal pro-B-type natriuretic peptide (NT-proBNP)
N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/mL)
Time frame: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
Plasma biochemistry
glucose, urea, sodium, potassium, chloride, calcium, and phosphorus (mmol/L)
Time frame: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
Bone metabolism markers
total procollagen type 1 N-terminal propeptide (tP1NP) (µg/L), N-min osteocalcin (N-mOST) (µg/L), bone-specific alkaline phosphatase (BAP) (µg/L)
Time frame: 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)
C-terminal telopeptide of type I collagen (β-CTX) (ng/mL)
Time frame: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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