Inflammation, Bone Metabolism
Conditions
Brief summary
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.
Interventions
OTHERmedullary canal opening
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).
Sponsors
University of Split, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The main marker od inflamation | The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours. | CRP (mg/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood cells count | 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) |
| D-dimers concetration | The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours. | D-dimers (IU/L) |
| Coagulation: prothrombin time with international normalized ratio (INR) | The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours. | prothrombin time (seconds) |
| Coagulation: activated partial thromboplastin time (aPTT) | 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) |
| Fibrinogen concentration | The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours. | fibrinogen (g/L) |
| Creatinine concentration | The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours. | creatinine (μmol/L) |
| Concetration of N-terminal pro-B-type natriuretic peptide (NT-proBNP) | 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) |
| Plasma biochemistry | 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) |
| Bone metabolism markers | 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) |
| Bone metabolism marker C-terminal telopeptide of type I collagen (β-CTX) | 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) |
Countries
Croatia
Contacts
PRINCIPAL_INVESTIGATORVedran Kovacic
University of Split, School of Medicine
Outcome results
None listed