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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Michael Keller
- Telefonnummer: 614-293-2410
- E-post: michael.keller@osumc.edu
Studieorter
-
-
Ohio
-
Columbus, Ohio, Förenta staterna, 43230
- Rekrytering
- Jameson Crane Sports Medicine Institute
-
Kontakt:
- Michael Keller
- Telefonnummer: 614-293-2410
- E-post: michael.keller@osumc.edu
-
Huvudutredare:
- Jelle van der List, MD, PhD
-
Dublin, Ohio, Förenta staterna, 43016
- Rekrytering
- Ohio State Outpatient Care Dublin
-
Kontakt:
- Michael Keller
- Telefonnummer: 614-293-2410
- E-post: michael.keller@osumc.edu
-
Huvudutredare:
- Jelle van der List, MD, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Inget ingripande: No Aspiration
Each subject that is randomized to this arm will not receive an intervention and will only complete questionnaires. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quadriceps peak strength
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quadriceps atrophy
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Jelle van der List, MD, PhD, Ohio State University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY20252711
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