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

Trial Summary

What is the purpose of this trial?

The purpose of our study is to examine the effect of platelet-rich-plasma (PRP) injection on the short-term resolution of post-injury inflammation (biomarkers) and improvement in joint function in patients with acute ACL injury. This RCT has been powered based on the questionnaire KOOS Jr. but it is considered a 'pilot study' in terms of the lab analysis proposed.

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.

What data supports the effectiveness of the treatment for ACL injury?

Research shows that PRP injections can provide short-term pain relief after ACL surgery, but they don't seem to offer long-term benefits. PRP is a treatment that uses a part of your own blood to help with healing, but its effectiveness for ACL injuries is still being studied. ^{1 2 3 4 5}

Is PRP injection safe for treating ACL injuries?

Based on limited studies, PRP injections are generally considered to have very low risks, but the benefits are not yet proven. No significant adverse events have been reported in the literature for PRP injections in similar conditions. ^{1 4 5 6 7}

How does PRP treatment for ACL injury differ from other treatments?

PRP (Platelet-Rich Plasma) treatment for ACL injuries is unique because it uses a concentration of a patient's own platelets to potentially aid in healing and reduce inflammation, unlike traditional surgery which involves physically repairing the ligament. While PRP may offer short-term pain relief, its long-term benefits are not well-established compared to surgical options. ^{1 3 4 8 9}

Eligibility Criteria

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 have had inflammatory arthritis or an infection in my joint.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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) 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The efficacy of platelet rich plasma on anterior cruciate ligament reconstruction: a systematic review and meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Biologic agents for anterior cruciate ligament healing: A systematic review. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Italy pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma therapy or arthroscopic surgery on repair of anterior cruciate ligament rupture. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma treatment for ligament and tendon injuries. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Time-Dependent Effect of Platelet-Rich Plasma in Reducing Donor-Site Pain After Anterior Cruciate Ligament Reconstruction. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma and Stem Cell Injections in the Treatment of Arthritis of the Knee. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of Platelet-Rich Plasma on Clinical Outcomes After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma enhances autograft revascularization and reinnervation in a dog model of anterior cruciate ligament reconstruction. [2017]