PRP Injections for ACL Injury

Overseen By Jessica Andres-Bergos, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Hospital for Special Surgery, New York

Must not be taking: Steroids, Hyaluronic acid, PRP

Disqualifiers: Prior ACL reconstruction, Cartilage repair, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether platelet-rich plasma (PRP) injections can reduce inflammation and improve joint function after an ACL injury. Participants will receive either a PRP injection or a placebo (a harmless saline solution) before and during ACL surgery. This trial suits individuals who have recently (within 6 weeks) suffered an ACL injury and may also have a meniscus injury requiring repair. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have had a steroid, hyaluronic acid, or PRP injection in the past 6 months, you cannot participate.

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

Research shows that platelet-rich plasma (PRP) injections are generally safe for treating ACL injuries. In past studies, patients who received PRP injections reported better knee stability and function. For instance, one study found that PRP helped patients quickly return to their pre-injury condition with good ligament healing.

Importantly, these studies did not find any major side effects from PRP injections, suggesting that most patients tolerate it well. However, some studies have mixed results about the long-term benefits of PRP for knee function. In terms of safety, PRP appears to be a reliable option with no major safety concerns reported.

For those considering participation in a trial involving PRP, this information may reassure them about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ACL injury?

Researchers are excited about using Platelet Rich Plasma (PRP) injections for ACL injuries because PRP utilizes the body's own healing components, which may enhance recovery. Unlike standard treatments like physical therapy and surgery alone, PRP involves injecting concentrated platelets from the patient's blood directly into the injury site. This method could potentially accelerate healing and improve outcomes by releasing growth factors that aid tissue repair. While traditional methods focus on stabilization and rehabilitation, PRP offers a biological approach that could revolutionize recovery timelines and effectiveness.

What evidence suggests that PRP injections might be an effective treatment for ACL injury?

Research has shown that platelet-rich plasma (PRP) injections might stabilize the knee and reduce pain after ACL (anterior cruciate ligament) injuries. Some studies suggest that PRP can improve knee function in the short and medium term following ACL reconstruction surgery. It may also speed up early healing and reduce complications. However, not all studies agree. One study found that PRP did not significantly improve knee symptoms after surgery. In this trial, participants in the investigational arm will receive PRP injections, while those in the control arm will receive placebo saline injections. Overall, PRP shows potential for short-term benefits, but results can vary. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals aged 14-50 who have recently suffered an acute ACL injury, with or without a meniscus injury treatable by surgery. It's not suitable for those with severe cartilage damage, prior knee surgeries, injections within the last 6 months, inflammatory arthritis, joint infections, or non-English speakers.

Inclusion Criteria

I am either male or female.

I injured my ACL less than 6 weeks ago.

I am between 14 and 50 years old.

Exclusion Criteria

Non English speakers

I have had a previous cartilage repair surgery.

I need surgery for another ligament injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Treatment

Participants receive a pre-op injection (PRP for investigational arm, placebo for control arm) before ACLR surgery

1 week

Surgery and Post-operative Treatment

Participants undergo ACLR surgery with intra-op injection (PRP for investigational arm, placebo for control arm)

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of knee stability, strength, and pain

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Saline Injection
• Platelet Rich Plasma (PRP) Injection

Trial Overview The study is testing if injecting platelet-rich plasma (PRP) into the injured knee can reduce inflammation and improve joint function after an ACL injury. Participants will be randomly given either PRP or a placebo saline injection to compare outcomes.

How Is the Trial Designed?

Group I: Investigational Arm Experimental Treatment 1 Intervention

The investigational arm will receive a pre-op PRP injection, and ACLR surgery with PRP injection

Group II: Control Arm Placebo Group 1 Intervention

The control arm will receive a pre-op placebo injection of saline, and ACLR surgery with intra-op placebo injection

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Orthopedic Research and Education Foundation

Collaborator

Trials

23

Recruited

6,200+

Published Research Related to This Trial

In a clinical trial involving 100 patients with ACL ruptures, those who underwent arthroscopic surgery experienced significantly lower pain levels and greater range of motion (ROM) compared to those treated with platelet-rich plasma (PRP) injections, indicating that surgery may be more effective for knee stability and function.

Both treatment options led to improvements in pain and function over 14 months, but the surgical group showed superior outcomes, with a mean Visual Analogue Scale (VAS) score of 3.05 compared to 4.39 in the PRP group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma therapy or arthroscopic surgery on repair of anterior cruciate ligament rupture. Eslami, S., Fattah, S., Taher, SA., et al.[2022]

Platelet-rich plasma (PRP) application during anterior cruciate ligament reconstruction (ACLR) significantly reduced pain at the donor site for up to 12 months post-surgery, but this effect diminished by 24 months.

Despite the reduction in pain, PRP did not improve functional knee scores, indicating that while it may help with discomfort, it does not enhance overall knee function after ACLR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Dependent Effect of Platelet-Rich Plasma in Reducing Donor-Site Pain After Anterior Cruciate Ligament Reconstruction. de Andrade, ALL., Sardeli, AV., Garcia, TA., et al.[2021]

Intra-articular injections of platelet-rich plasma (PRP) and stem cells (SC) are increasingly used for treating knee arthritis, showing potential benefits in pain relief and improved function based on systematic review findings.

The review also highlights the need to monitor for adverse events associated with both PRP and SC injections, although specific adverse events were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma and Stem Cell Injections in the Treatment of Arthritis of the Knee. Wei, X., Riehl, JT.[2021]

A systematic review of 23 studies on biologic agents for ACL healing found that while platelet-rich plasma (PRP) is commonly used, its benefits are mainly limited to improved graft maturation rather than significant clinical outcomes or integration.

There is a lack of clinical trials on the use of stem cells for ACL healing, indicating a need for more research to understand their potential role in treating both partial and complete ACL tears.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biologic agents for anterior cruciate ligament healing: A systematic review. Di Matteo, B., Loibl, M., Andriolo, L., et al.[2020]

In a study involving healthy beagles, treatment of ACL grafts with autologous platelet-rich plasma (PRP) significantly increased the expression of key genes related to revascularization and reinnervation, suggesting that PRP may enhance the healing process during ACL graft maturation.

The gene expression changes were observed at multiple time points (2, 6, and 12 weeks post-surgery), indicating that PRP has a time-dependent effect on the healing process, particularly beneficial in the early stages of graft remodeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma enhances autograft revascularization and reinnervation in a dog model of anterior cruciate ligament reconstruction. Xie, X., Zhao, S., Wu, H., et al.[2017]

Platelet-rich plasma (PRP) is gaining popularity in sports medicine for its potential to deliver growth factors directly to injury sites, but there is currently a lack of high-level evidence from randomized clinical trials to support its efficacy in treating ligament and tendon injuries.

While the risks associated with PRP injections are considered low, the benefits remain unproven, highlighting the need for well-designed studies to determine optimal usage parameters and compare PRP with other treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma treatment for ligament and tendon injuries. Paoloni, J., De Vos, RJ., Hamilton, B., et al.[2011]

Platelet-rich plasma (PRP) treatment after ACL reconstruction showed significant short-term pain relief and functional improvement at 6 months, with clinically important reductions in pain scores and subjective knee function ratings.

However, after one year, PRP did not demonstrate any meaningful long-term benefits in pain or function, suggesting its efficacy may be limited to the short term, despite some studies indicating potential benefits for graft healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of platelet rich plasma on anterior cruciate ligament reconstruction: a systematic review and meta-analysis. Lv, ZT., Zhang, JM., Pang, ZY., et al.[2022]

Current research indicates that platelet-rich plasma (PRP) treatment does not significantly improve clinical outcomes for anterior cruciate ligament (ACL) injuries, suggesting limited efficacy at this time.

The variability in PRP preparations and numerous confounding factors in clinical studies highlight the need for further research to better understand the potential benefits of PRP in ACL surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial commentary: platelet-rich plasma in ACL surgery. Lubowitz, JH.[2018]

Platelet-rich plasma (PRP) injections during anterior cruciate ligament reconstruction (ACLR) can reduce postoperative pain and improve knee function in the short to medium term, particularly noted at 3 months post-surgery.

However, PRP does not enhance long-term outcomes, such as knee stability or graft healing, and does not affect tunnel enlargement, indicating its limited role in ACLR despite some short-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Platelet-Rich Plasma on Clinical Outcomes After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis. Zhu, T., Zhou, J., Hwang, J., et al.[2022]

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. 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.

4. wjgnet.com wjgnet.com/2218-5836/full/v16/i1/100693.htm

Platelet rich plasma and anterior cruciate ligament repair Platelet rich plasma (PRP) shows promise in enhancing early healing and reducing complications in anterior cruciate ligament reconstruction.

5. 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) ...

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 for ... 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, ...

7. 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 ...