- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07826208
Added Diagnostic Value of CT Arthrography to MR Arthrography in Wrist Internal Derangement
Added Diagnostic Value of CT Arthrography to MR Arthrography in Suspected Wrist Internal Derangement
The wrist is a complex joint made up of small bones, cartilage, and stabilizing ligaments, including the triangular fibrocartilage complex (TFCC) and intrinsic carpal ligaments. Because these structures are small and intricate, diagnosing internal joint damage (internal derangement) after trauma or chronic pain can be challenging.
Magnetic resonance arthrography (MRA), an imaging scan performed after injecting a contrast dye into the joint, is widely used because it shows soft tissues clearly. However, MRA can sometimes miss subtle bone fragments, cartilage defects, or partial ligament tears due to lower spatial resolution. Computed tomography arthrography (CTA) provides higher-detail spatial imaging and excels at identifying small bone injuries and ligament tears, though it offers less soft-tissue contrast than MRI.
The purpose of this study is to determine whether performing CT arthrography in addition to MR arthrography improves the detection and characterization of internal wrist pathologies compared with MR arthrography alone.
Participants enrolled in this study will:
- Undergo a clinical history taking and examination regarding their wrist symptoms.
- Receive an ultrasound-guided injection into the radiocarpal joint using a sterile mixture containing iodinated contrast, gadolinium contrast, saline, and a local numbing medication (xylocaine).
- Undergo a high-resolution CT scan of the wrist immediately following the injection.
- Undergo a 1.5T MR arthrography scan.
Researchers will compare the findings between the two imaging techniques to evaluate how often adding CT arthrography identifies additional lesions that were occult or inconclusive on MR arthrography.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged 15 to 60 years.
- Clinically suspected ligamentous, cartilage, tendon, or occult osseous wrist injury.
- Patients scheduled for MR arthrography of the wrist.
Exclusion Criteria:
- History of previous wrist surgery.
- Acute fractures requiring emergency management.
- Active wrist infection.
- Contraindications to iodinated or gadolinium-based contrast agents.
- Regional metallic implants causing significant imaging artifacts.
- Pregnancy.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Combined CT and MR Arthrography
Participants with clinically suspected wrist internal derangement receive an ultrasound-guided intra-articular injection into the radiocarpal joint using a combined mixture of iodinated contrast, gadolinium-based contrast, sterile saline, and xylocaine.
Immediately following the injection, participants undergo high-resolution computed tomography arthrography (HRCT) of the affected wrist.
This is followed by 1.5T magnetic resonance arthrography (MRA) with pre-contrast and post-contrast T1 SPIR sequences in axial, coronal, and sagittal planes to assess wrist internal derangement.
|
Under high-resolution ultrasound guidance, an intra-articular radiocarpal injection of approximately 5 mL is administered using a sterile mixture of iodinated contrast, gadolinium-based contrast, sterile saline, and xylocaine.
Immediately following injection, high-resolution CT arthrography is performed with 0.6 mm slice thickness and multiplanar reconstruction in axial, coronal, and sagittal planes.
Participants subsequently undergo 1.5T MR arthrography using coronal T2 SPIR (pre-contrast) and axial, coronal, and sagittal T1 SPIR sequences (post-contrast) using a dedicated wrist coil to evaluate internal derangement.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Patients With Additional Wrist Pathologies Detected by Adding CT Arthrography to MR Arthrography
기간: Baseline
|
Assessed as the proportion of participants in whom CT arthrography identifies additional internal derangement lesions (including intrinsic scapholunate and lunotriquetral ligament tears, central triangular fibrocartilage complex tears, cartilage defects, and occult osseous abnormalities) that were missed, occult, or inconclusive on MR arthrography alone.
|
Baseline
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
키워드
기타 연구 ID 번호
- CTA & MRA in Wrist Derangement
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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