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.

Study Overview

• Status: Completed
• Conditions: Inflammation, Bone Metabolism
• Intervention / Treatment: Other: medullary canal opening

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Split, Croatia
    • University Hospital of Split, 21000 Croatia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: manual medullary canal opening; Tthe medullary canal was opened under fluoroscopic guidance using a cannulated curved awl (14.0/3.2 mm).	Other: medullary 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).
Other: 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)	Other: medullary 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: University of Split, School of Medicine
• Investigators: Principal Investigator: Vedran Kovacic, University of Split, School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: May 31, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation
• Other Study ID Numbers: 520-03/25-01/65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No