Ultrasound Guided vs Unguided Intra-articular Knee Injections
Accuracy of Ultrasound Guided Versus Unguided Intra-articular Knee Injections in a Difficult to Inject Population
연구 개요
상세 설명
Patients with BMI > 30 and no clinically detectable knee effusions, with clinical symptoms and radiographic evidence of knee osteoarthritis or inflammatory arthritis, who have been referred for an intraarticular knee injection with corticosteroid will be randomized to either receive ultrasound guidance or not receive ultrasound guidance for their injection. One group will use the ultrasound guidance to position the needle. The other group will use landmarks to position the needle. For both groups, once the proceduralist is comfortable with needle placement for the injection, contrast dye will be injected and fluoroscopy used, to determine if the needle placement is correct. If it is determined the needle placement is not correct, fluoroscopy will be used to reposition it. Once needle placement is determined to be acceptable, the injection will be given. Patient demographics will be collected, along with pain scores preprocedure and two weeks post-procedure.
Subjects are responsible for all clinical costs associated with the injection.
There is no remuneration offered for study participation.
연구 유형
단계
- 3단계
연락처 및 위치
연구 장소
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic in Rochester
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria
- BMI > 30
- No clinically detectable knee effusion
- Clinical or radiographic evidence of knee osteoarthritis or inflammatory arthritis
- Must be referred to the Pain Clinic for treatment
Exclusion Criteria
- History of surgery on the affected knee
- Evidence of untreated systemic infection or systemic immunocompromise
- Evidence of cutaneous infections near the study knee injection site
- Patients on warfarin with an INR > 3.0
- Patients on oral antiplatelet or anticoagulant medications will be excluded if they have documented evidence of renal insufficiency (GFR < 60)
- History of iodinated contrast allergy or significant reaction to corticosteroids or lidocaine
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Ultrasound Machine Guided Injection
Use of ultrasound machine guidance in needle placement into the knee joint
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Use of ultrasound machine guidance for accurate needle placement into the knee joint
다른 이름들:
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활성 비교기: Unguided Injection
Needle placement performed without ultrasound machine guidance
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Needle placement will take place without ultrasound machine guidance
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Accuracy of the initial needle placement into the knee joint.
기간: During the initial needle placement, which can take 1-5 minutes
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The number of participants with accurate initial needle placement into the knee joint
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During the initial needle placement, which can take 1-5 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Improved clinical efficacy of US guided knee injections compared to unguided knee injections
기간: 30 minutes post injection
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Comparison of VAS scores 30 minutes after injection between subjects who had ultrasound guided knee injections and those who didn't
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30 minutes post injection
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Detection of knee effusions
기간: During procedure, which can take up to 30 minutes to complete
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Comparison of the accuracy of detecting a knee effusion on clinical examination versus ultrasonographically
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During procedure, which can take up to 30 minutes to complete
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Matthew Pingree, MD, Mayo Clinic
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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