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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| manual medullary canal opening | Other | Tthe medullary canal was opened under fluoroscopic guidance using a cannulated curved awl (14.0/3.2 mm). |
|
| mechanical drilling of the canal | Other | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medullary canal opening | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The main marker od inflamation | CRP (mg/L) | The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood cells count | blood concentrations of leukocytes, erythrocytes, platelets (×10⁹/L) | The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours. |
| D-dimers concetration |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Vedran Kovacic | University of Split, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Split, 21000 Croatia | Split | Croatia |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
D-dimers (IU/L)
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours. |