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Completed

NCT Number: NCT07648719

Effects of Femoral Canal Opening Technique on Biomarkers

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Split, 21000 Croatia

Split, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. The main marker od inflamation

    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)

Secondary outcomes

  1. Blood cells count

    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)

  2. D-dimers concetration

    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)

  3. Coagulation: prothrombin time with international normalized ratio (INR)

    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)

  4. Coagulation: activated partial thromboplastin time (aPTT)

    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)

  5. Fibrinogen concentration

    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)

  6. Creatinine concentration

    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)

  7. Concetration of N-terminal pro-B-type natriuretic peptide (NT-proBNP)

    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)

  8. Plasma biochemistry

    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)

  9. Bone metabolism markers

    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)

  10. Bone metabolism marker C-terminal telopeptide of type I collagen (β-CTX)

    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)

Sponsors and collaborators

Lead sponsor

University of Split, School of Medicine

Other

Registry information

Official study title

Effects of Femoral Canal Opening Technique on Inflammation, Coagulation, Organ Dysfunction, and Bone Metabolism

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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