PRP for Acetabular Labral Tears

(PRP for ALT Trial)

Overseen By Luke A Johnson, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: NSAIDs

Must not be taking: Oral steroids, Antibiotics

Disqualifiers: Hip surgery, Hip dysplasia, Fracture, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether platelet-rich plasma (PRP), which is blood enriched with extra platelets, can relieve hip pain caused by tears in the labrum, a cartilage in the hip. The study involves injecting PRP directly into the hip joint to assess improvements in pain and function. Individuals who have experienced hip or groin pain for more than six weeks, despite treatments like physical therapy or medication, might be suitable candidates. Participants will complete surveys and undergo medical tests during the trial to monitor their progress. As an unphased trial, this study provides a unique opportunity to explore a promising treatment option for those seeking relief from persistent hip pain.

Do I have to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you must have failed at least 6 weeks of conservative management, which includes NSAIDs, and you cannot have taken oral steroids in the last three months.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you should not have taken oral steroids in the last three months. It's best to discuss your specific medications with the trial team.

What prior data suggests that this method is safe for treating acetabular labral tears?

Research has shown that platelet-rich plasma (PRP) is generally safe for treating hip problems like acetabular labral tears. In recent studies, many patients reported significant pain relief after receiving PRP injections, suggesting the treatment is well-tolerated with few serious side effects.

A review that combined results from multiple studies found promising outcomes for PRP in reducing hip pain and did not reveal major safety concerns. However, some studies noted that the quality of evidence is low, indicating a need for more research to confirm these findings.

Overall, based on current information, PRP is considered a safe option to explore for hip pain. Trials regularly monitor participants through surveys and medical tests to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike current treatments for acetabular labral tears, which often involve physical therapy, anti-inflammatory medications, or surgery, Platelet-Rich Plasma (PRP) offers a unique approach. PRP is derived from the patient's own blood and is rich in growth factors that can potentially accelerate healing and reduce inflammation directly at the site of injury. Researchers are excited about PRP because it targets tissue repair at a cellular level, which might offer faster recovery times and improve joint function without the need for invasive surgical procedures.

What evidence suggests that platelet-rich plasma might be an effective treatment for hip pain?

Research shows that platelet-rich plasma (PRP) can effectively treat hip pain, including tears in the hip joint. A review of multiple studies found that PRP reduces hip pain. It matches the effectiveness of other treatments, such as hyaluronic acid, for certain hip conditions. PRP uses a part of the blood high in platelets, which aid in healing and pain relief. Overall, early findings suggest that PRP could be a useful option for people with hip pain from labral tears. Participants in this trial will receive an intra-articular hip injection of PRP to evaluate its effectiveness specifically for acetabular labral tears. ^{1 2 5 6 7}

Who Is on the Research Team?

Dan Cushman, MD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for individuals experiencing hip pain due to acetabular labral tears, which is damage to the cartilage in the hip joint. Participants must be willing to complete surveys and undergo medical tests through various communication methods like email, text, in person or phone.

Inclusion Criteria

Radiographs with Tonnis grade < 2 (i.e., 0 or 1)

My MRI shows I have a tear in the hip's labral.

I had a hip injection guided by ultrasound that relieved over half of my pain.

Exclusion Criteria

I am currently on antibiotics for an infection.

I have had a hip injection, other than anesthetic, in the last 6 months.

I have had surgery on my hip before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intra-articular hip injection of neutrophil-poor PRP

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 1, 3, 6, and 12 months

12 months

4 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Platelet-Rich Plasma

Trial Overview The study is testing Platelet-Rich Plasma (PRP) therapy on patients with acetabular labral tears. PRP involves using a concentration of platelets from the patient's own blood to potentially heal tissue and reduce pain.

How Is the Trial Designed?

Group I: Intra-Articular hip injection of PRP Experimental Treatment 1 Intervention

Single Group Assignment Recruitment will occur at the University of Utah Orthopedic Center by physician and study staff members medical chart review before patient visits. 45 mL of blood will be collected from eligible participants and processed. A single processed neutrophil-poor PRP injection will be given once to a single hip.

Platelet-Rich Plasma is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Platelet-Rich Plasma for:

• Hip labral tears
• Osteoarthritis
• Musculoskeletal injuries

Approved in European Union as Platelet-Rich Plasma for:

• Orthopedic conditions
• Sports injuries
• Degenerative joint diseases

Approved in Canada as Platelet-Rich Plasma for:

• Musculoskeletal disorders
• Joint pain
• Soft tissue injuries

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

Intraoperative injection of platelet-rich plasma (PRP) during hip arthroscopy for labral tears did not lead to improved clinical outcomes compared to a control group receiving bupivacaine, as shown in a study of 306 patients followed for at least 2 years.

Patients who received PRP reported slightly higher pain scores and lower modified Harris Hip Scores at 2 years post-surgery, indicating that PRP may not be beneficial for this type of procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical results of hip arthroscopy for labral tears: a comparison between intraoperative platelet-rich plasma and bupivacaine injection. Redmond, JM., Gupta, A., Stake, CE., et al.[2022]

Platelet-rich plasma (PRP) treatment for hip osteoarthritis showed improvements in patient-reported outcomes for up to one year, but did not significantly outperform hyaluronic acid (HA) in reducing pain at any follow-up period.

For intra-articular hip disorders like femoroacetabular impingement syndrome and labral tears, PRP did not demonstrate a statistically significant difference in clinical outcomes compared to control treatments, indicating a need for more high-quality studies to clarify its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation Methods and Clinical Outcomes of Platelet-Rich Plasma for Intra-articular Hip Disorders: A Systematic Review and Meta-analysis of Randomized Clinical Trials. Garcia, FL., Williams, BT., Polce, EM., et al.[2022]

In a study of 8 patients with acetabular hip labral tears who had not responded to conservative treatments, ultrasound-guided injection of platelet-rich plasma significantly improved hip function and reduced pain over 8 weeks, as measured by the Harris Hip Score and visual analog scale.

The results showed consistent and statistically significant improvements at 2, 6, and 8 weeks post-injection, indicating that this minimally invasive technique may be an effective option for symptom relief in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Platelet-Rich Plasma for the Treatment of Acetabular Labral Tear of the Hip: A Pilot Study. De Luigi, AJ., Blatz, D., Karam, C., et al.[2020]

In a study of 35 patients undergoing arthroscopic labral repair and femoral neck osteoplasty, the use of platelet-rich plasma (PRP) injections did not lead to improved clinical outcomes compared to saline injections, as measured by various hip scores up to one year post-surgery.

However, fewer patients in the PRP group experienced bruising compared to the saline group, suggesting a potential safety benefit of PRP in reducing post-operative ecchymosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of platelet enriched plasma on clinical outcomes in patients with femoroacetabular impingement following arthroscopic labral repair and femoral neck osteoplasty. LaFrance, R., Kenney, R., Giordano, B., et al.[2020]

Intra-articular injections of platelet-rich plasma (PRP) after hip arthroscopic surgery significantly reduced postoperative pain at 48 hours compared to the control group, indicating a potential benefit in managing early postoperative discomfort.

PRP treatment also resulted in fewer joint effusions at 6 months post-surgery, suggesting it may help reduce inflammation; however, no significant long-term clinical benefits were observed in hip function scores compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma Augmentation of Arthroscopic Hip Surgery for Femoroacetabular Impingement: A Prospective Study With 24-Month Follow-up. Rafols, C., Monckeberg, JE., Numair, J., et al.[2022]

In a study involving 48 rabbit osteochondral defects, treatment with platelet-rich plasma (PRP) significantly improved the healing of articular cartilage compared to untreated defects.

PRP, when combined with poly-lactic-glycolic acid (PLGA), enhanced the formation of new cartilage and bone, demonstrating its potential as an effective treatment for cartilage defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The regenerative effect of platelet-rich plasma on healing in large osteochondral defects. Sun, Y., Feng, Y., Zhang, CQ., et al.[2022]

Platelet-rich plasma (PRP) is created by centrifuging a patient's own blood, which concentrates platelets that release growth factors to enhance healing in musculoskeletal treatments.

The preparation method of PRP is crucial as it affects the concentration of growth factors, which can improve healing and also help with blood clotting after surgeries like hip arthroscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma Augmentation for Hip Arthroscopy. Mannava, S., Chahla, J., Geeslin, AG., et al.[2020]

In a study involving 10 patients with knee internal derangements, intraarticular injections of Platelet Rich Plasma (PRP) led to significant improvements in knee function and pain relief, as measured by various clinical scores at 4 and 12 weeks post-treatment.

The study demonstrated that PRP injections are a safe and effective conservative treatment option for knee injuries, with no reported adverse reactions and high patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Intraarticular Platelet Rich Plasma (PRP) Injection in Patients with Internal Knee Derangements. Razaq, S., Ejaz, A., Rao, SE., et al.[2016]

In a study involving 60 patients with knee cartilage lesions, pure platelet-rich plasma (P-PRP) injections showed significantly better short-term pain relief and functional improvement compared to leukocyte platelet-rich plasma (L-PRP) at 6 weeks post-treatment.

While both P-PRP and L-PRP demonstrated similar long-term efficacy after 12 months, the P-PRP group experienced fewer adverse events, suggesting it may be a safer option for initial treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Efficacy of Intra-Articular Injection with P-PRP Versus that of L-PRP in Treating Knee Cartilage Lesion: A Randomized Controlled Trial. Zhou, Y., Li, H., Cao, S., et al.[2023]

A systematic review of 19 studies revealed significant variability in the concentrations of platelets, leukocytes, and growth factors in platelet-rich plasma (PRP) produced by different separation systems, indicating that not all PRP is created equal.

The choice of PRP separation system should be tailored to the specific clinical application, as the ideal concentrations for effective treatment are still not well-defined, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concentrations of Blood Components in Commercial Platelet-Rich Plasma Separation Systems: A Review of the Literature. Oudelaar, BW., Peerbooms, JC., Huis In 't Veld, R., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7607802/

Preparation Methods and Clinical Outcomes of Platelet-Rich ... Treatment of OA with PRP demonstrated reductions in pain and improved patient-reported outcomes for up to 1 year. However, there was no statistically ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06332352

Intra-articular Platelet-Rich Plasma for Acetabular Labral ... According to a recent systematic review and meta-analysis, there is promising evidence that platelet rich plasma (PRP) is an effective treatment for hip ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666061X2200075X

Systematic Review Platelet-Rich Plasma Is Not Associated ... Platelet-Rich Plasma Is Not Associated With Improved Outcomes Following Hip Femoroacetabular Impingement Surgery: Very Low-Quality Evidence Suggests Hyaluronic ...

4. academic.oup.com academic.oup.com/jhps/advance-article/doi/10.1093/jhps/hnaf008/8058728

Effectiveness of platelet-rich plasma in pain management of ... The study finds that PRP treatment is at least as effective as HA treatment in reducing hip pain for OA secondary to DDH.

5. benjamindombmd.com benjamindombmd.com/pdf/clinical-results-hip-arthroscopy-labral-tears.pdf

Clinical Results of Hip Arthroscopy for Labral Tears Purpose: The purpose of this prospective comparative study was to evaluate the effect of intraoperative platelet-rich plasma (PRP) injection on the outcomes ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8460156/

The use of biologics to improve patient-reported outcomes ... The study concluded that intraoperative PRP injections do not appear to provide clinical improvements in patients undergoing hip arthroscopy for ...

7. londoncartilage.com londoncartilage.com/the-role-of-platelet-rich-plasma-injection-in-the-conservative-treatment-of-acetabular-labrum-tears/

The Role of Platelet-Rich Plasma Injection in ... Recent studies on PRP injections for acetabular labrum tears are encouraging. Many patients report significant reductions in pain and noticeable ...