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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Platelets are small cells found in the blood that help form clots and stop bleeding. Platelet-rich plasma is blood that contains more platelets than normal and can be given to help people with pain. Tears of the Labrum to the hip (the cartilage "suction cup" that holds the ball to the socket of the hip) cause hip pain. The study wants to see if a portion of the patient's blood, the platelets, will help relieve hip pain and function. Participation requires completing surveys by email, text message, in person, and/or by telephone. Medical tests will also be done to track the health of participants.

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 data supports the idea that PRP for Acetabular Labral Tears is an effective treatment?

The available research shows mixed results for the effectiveness of PRP in treating acetabular labral tears. One study found that PRP did not significantly improve clinical outcomes compared to a placebo up to one year after surgery. However, it did show a reduction in bruising compared to the placebo group. Another study suggests that PRP can be safely used for this condition, but it does not provide specific data on its effectiveness. Overall, while PRP is safe, its effectiveness compared to other treatments remains uncertain based on the current research. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Platelet-Rich Plasma (PRP) for acetabular labral tears?

Research shows that PRP injections may reduce bruising after hip surgery, but they do not significantly improve overall recovery or outcomes for acetabular labral tears compared to a placebo. ^{1 2 3 4 5}

What safety data exists for PRP treatment?

PRP is considered a safe therapeutic option for musculoskeletal conditions, including tendon, muscle, bone, and cartilage injuries. Studies have shown that intraarticular PRP injections are safe and effective, with significant improvements in clinical scores and patient satisfaction. No major adverse reactions have been reported in the studies reviewed. ^{2 6 7 8 9}

Is PRP treatment generally safe for humans?

PRP (Platelet-Rich Plasma) is considered a very safe treatment option for various conditions, including tendon, muscle, bone, and cartilage injuries, with studies showing it is safe and effective for knee issues. ^{2 6 7 8 9}

Is Platelet-Rich Plasma (PRP) a promising treatment for acetabular labral tears?

Platelet-Rich Plasma (PRP) is being explored as a treatment for acetabular labral tears, and some studies suggest it might help with healing and reducing symptoms. However, the evidence is mixed, and more research is needed to confirm its effectiveness. ^{1 2 3 4 10}

How does the treatment PRP differ from other treatments for acetabular labral tears?

PRP (Platelet-Rich Plasma) is unique because it uses a concentration of platelets from the patient's own blood to potentially promote healing and reduce symptoms. Unlike standard treatments, PRP is injected directly into the hip joint, and it may offer regenerative benefits by enhancing tissue repair, although its effectiveness compared to other treatments is still being studied. ^{1 2 3 4 10}

Research Team

Dan Cushman, MD

Principal Investigator

University of Utah

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Clinical results of hip arthroscopy for labral tears: a comparison between intraoperative platelet-rich plasma and bupivacaine injection. [2022]

2. United States 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. [2022]

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

Use of Platelet-Rich Plasma for the Treatment of Acetabular Labral Tear of the Hip: A Pilot Study. [2020]

4. England 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. [2020]

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

Platelet-Rich Plasma Augmentation of Arthroscopic Hip Surgery for Femoroacetabular Impingement: A Prospective Study With 24-Month Follow-up. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma Augmentation for Hip Arthroscopy. [2020]

7. Pakistan pubmed.ncbi.nlm.nih.gov

The Role of Intraarticular Platelet Rich Plasma (PRP) Injection in Patients with Internal Knee Derangements. [2016]

8. Australia 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. [2023]

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

Concentrations of Blood Components in Commercial Platelet-Rich Plasma Separation Systems: A Review of the Literature. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

The regenerative effect of platelet-rich plasma on healing in large osteochondral defects. [2022]