University Hospital of Split, 21000 Croatia
Split, Croatia
NCT Number: NCT07648719
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Split, Croatia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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 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 (IU/L)
Time frame: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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.
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 (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 (μmol/L)
Time frame: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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.
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.
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.
C-terminal telopeptide of type I collagen (β-CTX) (ng/mL)
University of Split, School of Medicine
Other
Effects of Femoral Canal Opening Technique on Inflammation, Coagulation, Organ Dysfunction, and Bone Metabolism
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