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Effects of Femoral Canal Opening Technique on Biomarkers

12. juni 2026 opdateret af: Vedran Kovacic, University of Split, School of Medicine

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: manual medullary canal opening
Tthe medullary canal was opened under fluoroscopic guidance using a cannulated curved awl (14.0/3.2 mm).
Andet: 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).
Andet: 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)
Andet: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The main marker od inflamation
Tidsramme: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
CRP (mg/L)
The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood cells count
Tidsramme: 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)
The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
D-dimers concetration
Tidsramme: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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)
Tidsramme: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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)
Tidsramme: 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)
The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
Fibrinogen concentration
Tidsramme: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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
Tidsramme: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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)
Tidsramme: 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)
The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
Plasma biochemistry
Tidsramme: 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)
The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
Bone metabolism markers
Tidsramme: 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)
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)
Tidsramme: 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)
The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Split, School of Medicine

Efterforskere

  • Ledende efterforsker: Vedran Kovacic, University of Split, School of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2025

Primær færdiggørelse (Faktiske)

30. november 2025

Studieafslutning (Faktiske)

30. november 2025

Datoer for studieregistrering

Først indsendt

31. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 520-03/25-01/65

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