[미국 FDA에서 승인 또는 허가되지 않은 장치의 시험]
[미국 FDA의 승인 또는 허가를 받지 않은 기기의 시험]
Patients will be asked to take part in this research study because they have mild-to-moderate knee osteoarthritis (OA) and were referred clinically for a procedure called Genicular Artery Embolization (GAE). Osteoarthritis is the most common form of arthritis. It occurs when the protective cartilage that cushions the ends of the bones wears down over time. The symptoms of OA include pain or aching, stiffness, decreased range of motion, and swelling. The purpose of this study is to evaluate the safety and effectiveness of GAE for the treatment of knee pain attributed to OA.
Research participants will be in this research study for about 3 years. The study includes a screening visit, GAE procedure, and six follow-up visits.
At the screening visit, a review of their medical history, demographics, and medications will be collected; physical examination will be completed; knee x-ray will be done; and two questionnaires on your knee pain will be administered. The GAE procedure will involve receiving sedation or medication to help them relax, lidocaine injected under the skin in the area of the body where catheters will be inserted into one of your arteries and then using x-ray, a catheter will be directed to the arteries supplying the lining of the knee. Then tiny microspheres will be injected into the artery to decrease the blood supply to this knee joint tissue.
The follow-up visits up to 12 months will include a focused physical examination of the treated knee, documentation of medications, and two questionnaires will be administered. The follow-up visits at year 2 and 3 will include documentation of medications and any new treatments for OA as well as completion of two questionnaires. Follow-up visits maybe conducted in clinic or remotely.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Kristie Kennedy, MA
- 전화번호: 312-695-4023
- 이메일: kristie.kennedy@northwestern.edu
연구 연락처 백업
- 이름: Robert Lewandowski, MD
- 전화번호: 312-695-9121
- 이메일: r-lewandowki@northwestern.edu
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60611
- 모병
- Northwestern University
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연락하다:
- Robert Lewandowski, MD
- 전화번호: 312-695-9121
- 이메일: r-lewandowski@northwestern.edu
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 40-80 years
- Mild-to-moderate knee OA as determined by radiographs demonstrating Kellgren- Lawrence grade 2-3
- Self-reported pain of at least 5/10 VAS questionnaire
- Failure of conservative therapy, such as pain medications, for at least 3 months
- Patient must understand and sign the informed consent
- Patient can comply with the proposed follow-up schedule
- Patient can follow the post-operative management
Exclusion Criteria:
- History of rheumatoid arthritis
- Renal insufficiency precluding angiography (GFR < 50 mL/min)
- Irreversible coagulopathy
- Previous knee arthroplasty on the intended knee
- Existing knee joint infection
- Kellgren-Lawrence grade 1 or 4
- Severe atherosclerosis as manifest by claudication and/or diminished peripheral pulses
- Life expectancy < 6 months
- Infectious arthritis
- Allergy to iodinated contrast resulting in anaphylaxis
- Pregnant or interested in becoming pregnant three months from the date of the GAE procedure
- Involved in litigation or worker's compensation claims
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: GAE Procedure
All participants will undergo a procedure called Genicular Artery Embolization (GAE) that will be done to try to reduce the pain in their knees.
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Genicular Artery Embolization is performed by either inserting a small catheter into the artery of the upper thigh or an artery at the wrist, and with the use of x-ray, the catheter is guided to the arteries supplying the lining of the knee.
Tiny particles are then injected through the catheter into these arteries, reducing the blood supply.
These small particles are considered a medical device called Embosphere Microspheres.
These microspheres are approved by the Food and Drug Administration (FDA) in the United States to treat hypervascular tumors; in the prostate arteries to relieve symptoms related to benign prostate hyperplasia; and to address arteriovenous malformations.
The use of Embosphere Microspheres in this study is considered experimental as it has not been approved by the FDA to reduce pain associated with knee OA.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient safety endpoints
기간: Screening/baseline, 1, 3, and 6 months
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Primary safety endpoints include: 1. Incidence and severity of adverse events (AEs). These include:
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Screening/baseline, 1, 3, and 6 months
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Objective clinical endpoints - Cone beam computed tomography
기간: Immediately pre-and post-embolization
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Change in enhancement on cone beam computed tomography (CT)
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Immediately pre-and post-embolization
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Objective clinical endpoints - VAS
기간: Screening/baseline, 1, 3, 6, 12, 24 and 36 months
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Change in Visual Analogue Scale (VAS), a measurement instrument where 0 represents the minimum value (e.g., no pain) and 100 (or 10) represents the maximum value (e.g., worst imaginable pain).
Consequently, higher scores indicate a worse outcome (more pain/severity), while lower scores indicate a better outcome
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Screening/baseline, 1, 3, 6, 12, 24 and 36 months
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Objective clinical endpoints - WOMAC
기간: Screening/baseline, 1, 3, 6, 12, 24 and 36 months
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Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a measurement instrument designed to evaluate pain, stiffness, and physical function in patients with hip or knee osteoarthritis.
Higher scores on the WOMAC indicate a worse outcome (greater pain, stiffness, and functional limitations).
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Screening/baseline, 1, 3, 6, 12, 24 and 36 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Preliminary Effectiveness - WOMAC
기간: Screening/baseline, 1, 3, 6, and 12 months
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Secondary endpoint will be evaluated based on existing validated pain scoring systems.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a measurement instrument designed to evaluate pain, stiffness, and physical function in patients with hip or knee osteoarthritis will be utilized.
Higher scores on the WOMAC indicate a worse outcome (greater pain, stiffness, and functional limitations).
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Screening/baseline, 1, 3, 6, and 12 months
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Preliminary Effectiveness - VAS
기간: Screening/baseline, 1, 3, 6, and 12 months
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Secondary endpoint will be evaluated based on existing validated pain scoring systems.
The Visual Analogue Scale (VAS), a measurement instrument where 0 represents the minimum value (e.g., no pain) and 100 (or 10) represents the maximum value (e.g., worst imaginable pain) will be utilized.
Consequently, higher scores indicate a worse outcome (more pain/severity), while lower scores indicate a better outcome.
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Screening/baseline, 1, 3, 6, and 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Robert Lewandowski, MD, Northwestern University
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 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. .
Embosphere Microspheres에 대한 임상 시험
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Worthington-Kirsch, Robert L., M.D.Terumo Medical Corporation; Biocompatibles UK Ltd완전한
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Trust Bio-sonics, Inc.CMIC ASIA-PACIFIC, PTE. LTD., TAIWAN BRANCH모병
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GE HealthcareLaboratory Corporation of America완전한
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Assistance Publique - Hôpitaux de ParisMinistry of Health, France완전한
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Boston Scientific Corporation완전한자궁 신생물 | 평활근종 | 평활근종증 | 자궁 근종 | 월경과다미국
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Medical University of South Carolina종료됨