Arthrocentesis vs Observation Study for Acute ACL Tears (ASPIRATE)
Arthrocentesis Study for Perioperative Intervention on Reducing Arthritis and Trauma-related Effects
The ASPIRATE trial is a randomized controlled trial evaluating the effects of pre- and post-operative knee joint aspiration in patients with an ACL injury. The study aims to determine if removing knee joint fluid can mitigate the increasing inflammation after surgery, reduce quadriceps atrophy, improve short-term pain, enhance functional recovery, and lower long-term rates of post-traumatic knee osteoarthritis.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
While Anterior Cruciate Ligament Reconstruction (ACLR) successfully restores joint stability, patients still face challenges regarding long-term osteoarthritis and lower rates of returning to sports. Traumatic hemarthrosis-the buildup of blood in the joint following an injury and surgery-acts as a toxic agent that triggers cartilage degeneration. Furthermore, it causes arthrogenic muscle inhibition (AMI), which leads to quadriceps muscle shrinkage and abnormal walking patterns. This cycle is often referred to as the "second-hit phenomenon". While draining fluid from the knee (arthrocentesis) before surgery is common, performing repeat drainages after surgery to remove built-up blood is experimental. This study evaluates whether this low-cost, widely available procedure can safely interrupt that destructive cycle.
The main objective of this trial is to intervene in the hemarthrosis process to prevent or reduce the incidence of AMI and cartilage breakdown through pre- and post-operative joint drainage. Secondary objectives include assessing whether the procedure leads to less quadriceps muscle shrinkage, improves short-term pain, enhances leg strength at 3 and 6 months, accelerates return-to-sport rates, and reduces joint wear at a 1-year follow-up.
Eligible participants include individuals aged 15 to 40 years who experienced their injury 30 days or less prior, have a confirmed ACL tear, and have chosen to undergo ACLR using either a quadriceps tendon or bone-patellar tendon-bone autograft. Key exclusion criteria include previous knee or ACL surgery on the same leg, a cortisone injection within the previous 3 months, major multi-ligament repairs done at the same time (such as the MCL, PCL, or PLC), advanced osteoarthritis, pregnancy, or an inability to speak English fluently.
All participants will undergo standard ACLR surgery using their own tissue graft. Clinical assessments are conducted from baseline through 1 year, tracking patient surveys on knee pain, activity levels, and psychological readiness at baseline, 1 week, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year. Physical and imaging steps include measuring thigh circumference with a tape measure at every visit, performing leg strength tests on a special machine at 3 and 6 months, and taking standing knee X-rays with a specialized framing device at the 1-year mark to evaluate joint health.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Michael Keller
- 전화번호: 614-293-2410
- 이메일: michael.keller@osumc.edu
연구 장소
-
-
Ohio
-
Columbus, Ohio, 미국, 43230
- 모병
- Jameson Crane Sports Medicine Institute
-
연락하다:
- Michael Keller
- 전화번호: 614-293-2410
- 이메일: michael.keller@osumc.edu
-
수석 연구원:
- Jelle van der List, MD, PhD
-
Dublin, Ohio, 미국, 43016
- 모병
- Ohio State Outpatient Care Dublin
-
연락하다:
- Michael Keller
- 전화번호: 614-293-2410
- 이메일: michael.keller@osumc.edu
-
수석 연구원:
- Jelle van der List, MD, PhD
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 15 -40
- Time from injury to aspiration ≤30 days
- Patient with a confirmed ACL tear and have elected to have an ACL reconstruction using a quadriceps tendon (QT) or bone-patellar tendon-bone (BPTB) autograft tendon
Exclusion Criteria:
- Fear of needles or rejection of arthrocentesis
- Previous knee or ACL surgery on the affected knee
- Previous cortisone injection in the affected knee within the previous 3 months
- Concomitant procedures that involve repair or reconstruction of the medial collateral ligament (MCL), posterolateral corner (PLC) or posterior cruciate ligament reconstruction (PCL)
- Osteoarthritis Kellgren-Lawrence grade ≥3.
- Cartilage procedures beyond microfracture or chondroplasty
- Planned osteotomies or meniscus allograft transplantation (MAT)
- Muscular, vascular or neurological diseases that influence rehabilitation or surgery
- Current use of prednisone or cytostatic medication
- Obesity with a BMI ≥45
- Daily smoking
- History of illicit drug or alcohol abuse
- History of prior infection in knee
- History of chemotherapy treatment
- History of sickle cell disease
- Pregnancy during injury or surgery
- No mastery of the English language
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Aspiration
Each subject that is randomized to this arm will receive a knee aspiration both before and after ACL surgery. |
Aspiration is a minimally invasive medical procedure in which a sterile needle and syringe are inserted into the intra-articular space of the knee joint to extract excess synovial fluid that is built up around the knee space. |
|
간섭 없음: No Aspiration
Each subject that is randomized to this arm will not receive an intervention and will only complete questionnaires. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quadriceps peak strength
기간: 3 months and 6 months
|
The Biodex measurement physical device will be used to measure the isokinetic strength of the quadriceps muscle. The leg is brought from flexion to extension at 60 degrees per second and 300 degrees per second and the maximum force is measured for the quadriceps. This is compared to the contralateral side and expressed in the limb symmetry index (LSI) as the percentage of strength compared to the contralateral side. This is expressed N/m |
3 months and 6 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quadriceps atrophy
기간: 3 and 6 Months
|
The quadriceps circumference of the affected leg is measured in centimeters at 6 and 16 centimeters above the superior pole of the patella and compared to the contralateral side. |
3 and 6 Months
|
|
Short-term Pain
기간: 1 week, 2 weeks, 6 weeks, 3 months, 6 months and 1 year
|
The overall pain in the knee is assessed using a visual analog scale (VAS) questionnaire that is standardized, and this is compared to the preoperative baseline score. The score ranges from 0 to 10 with 0 indicating no pain and 10 indicating worst pain imaginable |
1 week, 2 weeks, 6 weeks, 3 months, 6 months and 1 year
|
|
Patient-reported outcome measures
기간: 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
The questionnaire subjective International Knee Documentation Committee (IKDC) will be obtained. The score ranges from 0 to 100 with 100 having a normal score and 0 an abnormal score. |
1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
|
Lysholm Score
기간: 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
The questionnaire Lysholm Score will be obtained. The score ranges from 0 to 100 with 100 having a normal score and 0 an abnormal score. |
1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
|
Forgotten Joint Score
기간: 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
The questionnaire Forgotten Joint Score will be obtained. The score ranges from 0 to 100 with 100 having a normal score and 0 an abnormal score. |
1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
|
Tegner activity score
기간: 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
The questionnaire Tegner activity score will be obtained. The score ranges from 0 to 100 with 100 having a normal score and 0 an abnormal score. |
1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
|
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
기간: 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
The questionnaire Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) will be obtained. The score ranges from 0 to 100 with 100 having a normal score and 0 an abnormal score. |
1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
|
Return to Sports
기간: 3 months, 6 months and 1 year.
|
Return to sports will be assessed using questionnaires: when they return to sports (months after surgery), if they have reached preinjury level of performance (yes/no) and whether they are fully return to previous level (yes/no). |
3 months, 6 months and 1 year.
|
|
Joint space narrowing on radiographs
기간: 1 year
|
Osteoarthritic changes at AP and Rosenberg views at 1 year of the medial and lateral compartment compared to preoperative radiographs measured in absolute millimeters at the narrowest area of the respective compartments |
1 year
|
|
Osteoarthritis grade on radiographs
기간: 1 year
|
Osteoarthritic changes at AP and Rosenberg views at 1 year of the medial and lateral compartment compared to preoperative radiographs measured as Kellgren-Lawrence scale (scale from 0 to 4 with 0 indicating no signs of osteoarthritis and 4 indicating end-stage bone-on-bone osteoarthritis) |
1 year
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Jelle van der List, MD, PhD, Ohio State University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- STUDY20252711
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD will not be shared.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .