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Effects of Femoral Canal Opening Technique on Biomarkers

2026년 6월 12일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 특수 증상
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: manual medullary canal opening
Tthe medullary canal was opened under fluoroscopic guidance using a cannulated curved awl (14.0/3.2 mm).
다른: 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).
다른: 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)
다른: 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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The main marker od inflamation
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Blood cells count
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Split, School of Medicine

수사관

  • 수석 연구원: Vedran Kovacic, University of Split, School of Medicine

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 3월 1일

기본 완료 (실제)

2025년 11월 30일

연구 완료 (실제)

2025년 11월 30일

연구 등록 날짜

최초 제출

2026년 5월 31일

QC 기준을 충족하는 최초 제출

2026년 6월 12일

처음 게시됨 (실제)

2026년 6월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 12일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 520-03/25-01/65

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Inflammation, Bone Metabolism에 대한 임상 시험

medullary canal opening에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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정황

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약물 개입

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스폰서 / 협력자

위치

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