Effects of Femoral Canal Opening Technique on Biomarkers

NCT07648719 | Completed

• 1 other identifier: 520-03/25-01/65
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation, Bone Metabolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Blood cells count

  The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.

• D-dimers concetration

  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)

  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)

  The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.

• Fibrinogen concentration

  The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.

Study Arms (2)

manual medullary canal opening

OTHER

Tthe medullary canal was opened under fluoroscopic guidance using a cannulated curved awl (14.0/3.2 mm).

Other: medullary canal opening

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)

Other: medullary canal opening

Interventions

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).

manual medullary canal opening; mechanical drilling of the canal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Study Sites (1)

University Hospital of Split, 21000 Croatia

Split, Croatia

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vedran Kovacic

  University of Split, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr. Vedran Kovacic

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 15, 2026
• Study Start: March 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)