Effects of Femoral Canal Opening Technique on Biomarkers
12 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
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Split, Kroatien
- University Hospital of Split, 21000 Croatia
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Övrig: manual medullary canal opening
Tthe medullary canal was opened under fluoroscopic guidance using a cannulated curved awl (14.0/3.2 mm).
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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).
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Övrig: 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)
|
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).
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The main marker od inflamation
Tidsram: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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CRP (mg/L)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Blood cells count
Tidsram: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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blood concentrations of leukocytes, erythrocytes, platelets (×10⁹/L)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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D-dimers concetration
Tidsram: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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D-dimers (IU/L)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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Coagulation: prothrombin time with international normalized ratio (INR)
Tidsram: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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prothrombin time (seconds)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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Coagulation: activated partial thromboplastin time (aPTT)
Tidsram: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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activated partial thromboplastin time (aPTT) (seconds)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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Fibrinogen concentration
Tidsram: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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fibrinogen (g/L)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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Creatinine concentration
Tidsram: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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creatinine (μmol/L)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
|
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Concetration of N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Tidsram: The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
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N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/mL)
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The investigators compared differences in blood parameters between the two groups at baseline, as well as differences after 72 hours.
|
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Plasma biochemistry
Tidsram: 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
Tidsram: 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)
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Vedran Kovacic, University of Split, School of Medicine
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2025
Primärt slutförande (Faktisk)
30 november 2025
Avslutad studie (Faktisk)
30 november 2025
Studieregistreringsdatum
Först inskickad
31 maj 2026
Först inskickad som uppfyllde QC-kriterierna
12 juni 2026
Första postat (Faktisk)
15 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 520-03/25-01/65
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