An interventional study of Knee Aspiration in Anterior Cruciate Ligament (ACL) Tear, sponsored by Ohio State University. Recruiting at 2 sites in United States. Open to participants aged 15 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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.
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.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's planned enrollment of 54 is below the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each subject that is randomized to this arm will receive a knee aspiration both before and after ACL surgery.
Procedure: Knee Aspiration
Each subject that is randomized to this arm will not receive an intervention and will only complete questionnaires.
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.
Quadriceps peak strength
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
Time frame: 3 months and 6 months
Quadriceps atrophy
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.
Time frame: 3 and 6 Months
Short-term Pain
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
Time frame: 1 week, 2 weeks, 6 weeks, 3 months, 6 months and 1 year
Patient-reported outcome measures
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.
Time frame: 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Lysholm Score
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.
Time frame: 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Forgotten Joint Score
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.
Time frame: 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Tegner activity score
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.
Time frame: 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
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.
Time frame: 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Return to Sports
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).
Time frame: 3 months, 6 months and 1 year.
Joint space narrowing on radiographs
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
Time frame: 1 year
Osteoarthritis grade on radiographs
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)
Time frame: 1 year
Plan to share: No — IPD will not be shared.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Dec 2028, 28 months after the start.
Of 46 non-industry interventional studies with no phase under Lacerations, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 72. This study's planned 28 months is above that.
Counting every sponsor, half of 50 studies reached it within 19 months; a quarter within 12 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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