RecruitingNCT07929922ClinicalTrials.gov record

Arthrocentesis vs Observation Study for Acute ACL Tears

Anterior Cruciate Ligament (ACL) Tear

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Not applicable
Age range: 15 years - 40 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 54 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Age 15 -40
2. Time from injury to aspiration ≤30 days
3. 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:

1. Fear of needles or rejection of arthrocentesis
2. Previous knee or ACL surgery on the affected knee
3. Previous cortisone injection in the affected knee within the previous 3 months
4. Concomitant procedures that involve repair or reconstruction of the medial collateral ligament (MCL), posterolateral corner (PLC) or posterior cruciate ligament reconstruction (PCL)
5. Osteoarthritis Kellgren-Lawrence grade ≥3.
6. Cartilage procedures beyond microfracture or chondroplasty
7. Planned osteotomies or meniscus allograft transplantation (MAT)
8. Muscular, vascular or neurological diseases that influence rehabilitation or surgery
9. Current use of prednisone or cytostatic medication
10. Obesity with a BMI ≥45
11. Daily smoking
12. History of illicit drug or alcohol abuse
13. History of prior infection in knee
14. History of chemotherapy treatment
15. History of sickle cell disease
16. Pregnancy during injury or surgery
17. No mastery of the English language

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

Aspiration

Each subject that is randomized to this arm will receive a knee aspiration both before and after ACL surgery.

Procedure: Knee Aspiration

No Aspiration

Each subject that is randomized to this arm will not receive an intervention and will only complete questionnaires.

Knee Aspiration PROCEDURE

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Quadriceps peak strength

Time frame: 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

Secondary measures

Quadriceps atrophy

Time frame: 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.

Short-term Pain

Time frame: 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

Patient-reported outcome measures