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Effects of Femoral Canal Opening Technique on Biomarkers

12. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The main marker od inflamation
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Blood cells count
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Split, School of Medicine

Ermittler

  • Hauptermittler: Vedran Kovacic, University of Split, School of Medicine

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. März 2025

Primärer Abschluss (Tatsächlich)

30. November 2025

Studienabschluss (Tatsächlich)

30. November 2025

Studienanmeldedaten

Zuerst eingereicht

31. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Juni 2026

Zuerst gepostet (Tatsächlich)

15. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 520-03/25-01/65

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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