Recruiting

Knee Joint Aspiration

Sponsor:

Ohio State University

Code:

NCT07929922

Conditions

Anterior Cruciate Ligament (ACL) Tear

Eligibility Criteria

Sex: All

Age: 15 - 40

Healthy Volunteers: Not accepted

Interventions

Knee Aspiration

Study Details

Brief summary:

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.

Conditions

Anterior Cruciate Ligament (ACL) Tear

Study ID

NCT07929922

Start date

Aug 1, 2026

Status verified date

Nov, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Aspiration

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

no intervention: No Aspiration

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

Interventions

Knee Aspiration

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.

Primary outcome measure

  • Quadriceps peak strength [ Time Frame: 3 months and 6 months ]

Central Contacts and Locations

Central contacts

Michael Keller

614-293-2410michael.keller@osumc.edu

Locations

Jameson Crane Sports Medicine Institute

Recruiting

Columbus, Ohio, United States, 43230

Contacts

Michael Keller

614-293-2410michael.keller@osumc.edu

Principal Investigator:

Jelle van der List, MD, PhD

Ohio State Outpatient Care Dublin

Recruiting

Dublin, Ohio, United States, 43016

Contacts

Michael Keller

614-293-2410michael.keller@osumc.edu

Principal Investigator:

Jelle van der List, MD, PhD

More Information

Sponsor

Ohio State University

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Keywords

  • Anterior Cruciate Ligament
  • Aspiration
  • Arthrocentesis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.