DRF Reposition Manual Reduction vs Finger-trap Traction (RepoDRF2)
Unterschied Der Reposition in Bruchspaltanästhesie Zur Reposition im Aushang Bei Einer Distalen Radiusfraktur - Eine Prospektiv Randomisierte Studie
연구 개요
상세 설명
Participants have sustained a distal radius fracture treated with cast immobilization. Two common conservative management approaches are being compared: (1) closed reduction under a local anesthetic (hematoma block) followed by traction and casting, and (2) immobilization after traction alone without formal reduction under anesthesia.
While the first method aims to restore anatomical alignment initially, loss of reduction may occur over time. The second method improves alignment but does not attempt full anatomical reduction.
The study hypothesis is that both approaches result in similar wrist alignment and functional outcomes after completion of treatment. The objective of this study is to determine whether reduction under local anesthesia followed by traction provides any advantage over traction alone in patients with distal radius fractures.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Tyrol
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Innsbruck, Tyrol, 오스트리아, 6020
- Univ.-Klinik für Orthopädie und Traumatologie
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Dorsally tilted distal radius fracture (DRF) > 10° (intra-articular or extra-articular) Dorsal comminution of the distal radius fracture
Fracture classification (AO), dorsally displaced:
- A2
- A3
- C1
- C2
- C3
Exclusion Criteria:
- Age under 18 years
- Non-displaced fractures of the radius
- Previous palmar displaced fractures of the radius
- Displacement greater than one shaft width
- Open fractures of the radius
- Bilateral radius fractures
- History of a previous radius fracture
- Inability to provide informed consent due to physical or mental disability
- Unavailability for follow-up examinations (e.g., abroad, polytrauma)
- Lack of full legal capacity
- Alcohol or drug abuse
- Allergy to local anesthetics
- Median nerve irritation
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: R: Manual Reduction
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Hematoma block 5 mL 2% lidocaine, followed by 15 minutes finger-trap traction and then manual reduction + cast application
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실험적: A: Finger-trap traction
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15 minutes finger-trap traction only and then cast application
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain difference between the groups
기간: From enrollment (Baseline) to the 12month Follow Up.
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Comparison of the pain score in the course of the follow ups between the groups.
0= no pain 10 = worst pain (maximal pain)
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From enrollment (Baseline) to the 12month Follow Up.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
MHQ Hand Score (Patient reported outcome)
기간: Enrollment until 12 month follow up
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Difference in functional outcome measured with MHQ (Michigan Hand Outcome Questionaire) between the two groups.
0 points= very poor hand function / maximum impairment; 100 points → optimal hand function, no impairment.
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Enrollment until 12 month follow up
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PRWE - Patient reported outcome
기간: Enrollment until 12month follow up
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Difference in functional outcome measured with PRWE (Patient-rated wrist evaluation) between the two groups.
0 points= optimal hand function, no impairment; 100 points → very poor hand function / maximum impairment.
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Enrollment until 12month follow up
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Grip strength
기간: 12 weeks until 12mo Follow up
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Difference in grip strength measured with dynanometer between the two groups.
Grip strength is compared to the contralateral non-injured wrist.
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12 weeks until 12mo Follow up
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Range of motion - functional outcome
기간: 12 weeks until 12 mo follow-up
|
Difference in functional outcome (range of motion) measured with goniometer after treatment between the two groups.
Range of Motion is compared to the contraltaeral non-injured wrist.
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12 weeks until 12 mo follow-up
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Radiological outcome
기간: Enrollment until 12 month Follow up
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Difference in radiological outcome between the two groups; especially, dorsal tilt, radial inclination and ulnar variance.
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Enrollment until 12 month Follow up
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Complications
기간: After treatment until 12 month Follow up
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Complications between the two groups.
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After treatment until 12 month Follow up
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RepoDRF2
- AOTrauma Research Austria 2020 (기타 보조금/기금 번호: AO Trauma)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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