Synovial Fluid Withdrawal or PRP Injection for ACL Tear

Overseen By Adam Yanke, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Chronic ACL tear, Rheumatoid arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two different treatments can reduce knee swelling after an ACL tear. Participants will either have fluid withdrawn from their knee, receive an injection of platelet-rich plasma (PRP) from their blood, or undergo both treatments. The goal is to determine which method best aids swelling and recovery. Ideal candidates for this trial have a recent ACL rupture, noticeable swelling, and are scheduled for ACL reconstruction surgery. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially benefit from innovative treatments.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Platelet-Rich Plasma (PRP) is generally safe for use in the knee. In past studies, patients who received PRP after ACL (anterior cruciate ligament) surgery experienced better knee function and less pain in the short to medium term. Most people tolerate PRP well. Additionally, PRP has been used in other treatments without major safety issues, which increases trust in its use. These studies have reported no major serious side effects from PRP. Overall, PRP appears to be a safe choice for those considering it as part of their ACL recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the use of Platelet-Rich Plasma (PRP) for ACL tears because it harnesses the body's natural healing processes. Unlike standard treatments such as physical therapy or surgery, PRP involves injecting concentrated platelets from the patient's own blood into the affected area, potentially speeding up recovery and improving tissue regeneration. Additionally, the trial compares PRP with synovial fluid withdrawal, aiming to understand its effectiveness better. This approach could offer a less invasive and more biologically harmonious alternative to traditional methods, making it an exciting area of exploration for potentially enhancing ACL tear recovery.

What evidence suggests that this trial's treatments could be effective for ACL tears?

This trial will compare the effects of synovial fluid withdrawal with the administration of platelet-rich plasma (PRP) for anterior cruciate ligament (ACL) tears. Research has shown that PRP can improve knee stability after ACL surgery. Studies have found that PRP reduces pain and enhances knee function in the short and medium term. Specifically, patients who received PRP reported significant improvements in their knee condition 12 months after surgery. However, PRP might not offer long-term benefits for knee symptoms and function. Overall, PRP could be a promising option for enhancing recovery after an ACL injury. ^{1 2 3 4 6}

Who Is on the Research Team?

Adam Yanke, MD, PhD

Principal Investigator

Associate Professor and Surgeon

Are You a Good Fit for This Trial?

This trial is for individuals with a sudden ACL tear and possibly associated conditions like arthritis. Participants should be scheduled for surgery and able to visit the clinic beforehand. Details on specific inclusion or exclusion criteria are not provided, but typically would involve age, overall health status, and absence of conditions that might interfere with the study.

Inclusion Criteria

English-speaking

I have a torn ACL with swelling.

I am scheduled for ACL reconstruction surgery.

Exclusion Criteria

Kellgren-Lawrence grade 2 changes on preoperative x-ray

It has been more than 3 weeks since my initial injury.

I am either younger than 18 or older than 50.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants undergo synovial fluid withdrawal and/or PRP injection at the preoperative clinic visit

1 day

1 visit (in-person)

Surgery

Participants undergo surgery with synovial fluid withdrawal at the time of surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Platelet-Rich Plasma (PRP)
• Synovial Fluid Withdrawal

Trial Overview The study is testing whether withdrawing excess knee joint fluid at different times (during surgery or before) or injecting Platelet-Rich Plasma (PRP) affects swelling after an acute ACL rupture. It's comparing these interventions to see which one helps more.

How Is the Trial Designed?

Group I: Platelet-Rich Plasma (PRP) and Two Synovial Fluid Withdrawals Experimental Treatment 3 Interventions

Subjects randomized to ARM 2 will have 2 synovial fluid withdrawals one at the preoperative visit and one at the time of surgery. Platelet-Rich Plasma (PRP) preparation and injection will happen at the preoperative clinic visit.

Group II: 3mL Synovial Fluid Withdrawal and Synovial Fluid Withdrawal at the Time of Surgery Experimental Treatment 2 Interventions

Subjects randomized to Arm 3 will have 3mL withdrawal of synovial fluid at the preoperative visit and 1 synovial fluid withdrawal at the time of surgery

Group III: Two Synovial Fluid Withdrawals Active Control 2 Interventions

Subjects randomized to Arm 1 will have 2 synovial fluid withdrawals; one at the preoperative clinic visit and one at the time of surgery

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Arthroscopy Association of North America (AANA)

Collaborator

Trials

1

Recruited

130+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8811441/

Effects of Platelet-Rich Plasma on Clinical Outcomes After ... PRP applied alongside ACLR could reduce postoperative pain and improve knee function in the short and medium terms but is ineffective in the long term.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1008127525000860

Platelet-rich plasma in anterior cruciate ligament ... Our findings provide moderate evidence that PRP can significantly enhance knee stability post-ACL reconstruction.

3. frontiersin.org frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2025.1625271/full

The impact of platelet-rich plasma injection on anterior ... The PRP group exhibited significant improvement in IKDC scores at 12 months post-operatively (mean difference: 2.09, P = 0.01, I2 = 23%), while Lysholm scores ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07185802

NCT07185802 | Clinical Outcome of Intra Articular Injection ... This clinical trial will evaluate the effectiveness of platelet-rich plasma (PRP) injections for patients with anterior cruciate ligament (ACL) ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818559

Intra-Articular Platelet-Rich Plasma Injection After Anterior ... In this study among patients with ACLR, the addition of postoperative PRP injection did not significantly improve knee symptoms and function.

6. cureus.com cureus.com/articles/225028-conservative-treatment-using-platelet-rich-plasma-for-acute-anterior-cruciate-ligament-injuries-in-highly-active-patients-a-retrospective-survey

Conservative Treatment Using Platelet-Rich Plasma ... In the present study, all 10 patients were able to return to their pre-injury levels quickly and in good condition, with good ligament repair, ...