Extension Block Pinning vs Conservative Treatment for Mallet Finger Fractures (PO-EBPT)
Pin Orthosis Extension Block Pinning Versus Conservative Treatment for Doyle Type 4B Mallet Fractures
Mallet finger fractures are injuries affecting the tip of the finger and can be treated either with splinting or surgery. However, there is no clear agreement on which treatment provides better outcomes for certain types of these fractures.
In this study, patients with mallet finger fractures were randomly assigned to receive either surgical treatment using a pin-orthosis extension-block pinning technique or conservative treatment with splint immobilization. Patients were followed at regular intervals, and outcomes such as finger movement, function, bone healing, and complications were evaluated over time.
The purpose of this study is to compare these two treatment approaches and determine which one leads to better clinical and functional outcomes.
연구 개요
상태
상세 설명
Mallet finger fractures, particularly those involving a significant portion of the distal interphalangeal joint articular surface, present a therapeutic challenge, and there is no consensus regarding the optimal treatment strategy. Both conservative management with splinting and various surgical techniques have been described in the literature.
This randomized controlled trial was designed to compare the clinical and radiographic outcomes of the pin-orthosis extension-block pinning technique and conventional conservative treatment in patients with mallet finger fractures. Patients were randomly assigned to either surgical or conservative treatment groups and followed at regular intervals.
Clinical and functional outcomes were assessed throughout the follow-up period to evaluate the effectiveness and safety of both treatment approaches."
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
Sultangazi
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Istanbul, Sultangazi, 터키 (Türkiye), 34265
- Haseki Training and Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age between 18 and 65 years
- Acute mallet fracture (≤ 3 weeks from injury)
- Fracture fragment involving 20-50% of the distal interphalangeal (DIP) joint articular surface
Exclusion Criteria:
- Open fractures
- Chronic mallet fractures (> 3 weeks from injury)
- Fracture fragment involving more than 50% of the DIP joint articular surface
- Open physes
- Inability to complete 12-month follow-up
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Surgical Treatment (PO-EBPT)
Participants in this group underwent surgical treatment using the pin-orthosis extension-block pinning technique.
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The pin-orthosis extension-block pinning technique was performed under appropriate anesthesia.
A Kirschner wire was used to block extension at the distal interphalangeal joint and stabilize the fracture fragment, followed by immobilization with an orthosis.
The fixation was maintained for a defined period, and patients were followed according to the study protocol.
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활성 비교기: Conservative Treatment (Splinting)
Participants in this group received conservative treatment with splint immobilization of the distal interphalangeal joint.
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Conservative treatment consisted of continuous splint immobilization of the distal interphalangeal joint in extension.
Patients were instructed to maintain uninterrupted splint use for the recommended duration with regular follow-up visits to monitor compliance and clinical progress.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Distal Interphalangeal Joint Extension Lag
기간: 12 months
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Degree of extension lag at the distal interphalangeal joint measured using a goniometer.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Distal Interphalangeal Joint Range of Motion
기간: Up to 12 months (assessed at 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months)
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Range of motion of the distal interphalangeal joint measured in degrees.
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Up to 12 months (assessed at 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months)
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Functional Outcome According to Crawford Criteria
기간: 12 months
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Functional outcome assessed using the Crawford classification system.
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12 months
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Fracture Union
기간: Up to 12 months (assessed at 6 weeks, 3 months, 6 months, and 12 months)
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Radiographic evidence of fracture healing assessed during follow-up.
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Up to 12 months (assessed at 6 weeks, 3 months, 6 months, and 12 months)
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Complication Rate
기간: Up to 12 months
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Incidence of treatment-related complications observed during the study period.
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Up to 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kemal A Col, Doctor, Haseki Training and Research Hospital
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
- 39-2022
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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