Intra-articular Platelet-Rich Plasma for Acetabular Labral Tears (PRP for ALT)

March 25, 2024 updated by: Daniel Cushman, University of Utah

Intra-articular Platelet-Rich Plasma in the Management of Acetabular Labral Tears: a Prospective Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Acetabular labral tears (ALT) have been reported to have a prevalence of 22-55% in patients presenting with hip or groin pain. Etiologies of ALT include femoral acetabular impingement (FAI) as the most common followed by trauma, degeneration, dysplasia, hypermobility, etc. The fibrocartilaginous acetabular labrum is an important structure in the maintenance of hip perseveration and biomechanics. Several functions include decreasing stress on articular surfaces by increasing surface contact area, maintaining a pressurized layer of intra-articular fluid to distribute mechanical forces, and assisting in joint stability. The consequences of labral pathology are not fully understood, however, prior studies have indicated that there is a correlation between acetabular labral lesions and chondral injury contributing to the development of early degenerative hip disease.

Based on current evidence, it is suggested that the highest degree of clinical accuracy in the diagnosis of a symptomatic acetabular labral tear is with a combination of clinical history, physical examination, advanced imaging such as magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA), and diagnostic injection. Conservative management trials are often considered for initial treatment and include relative rest, activity modification, anti-inflammatory medication, and physical therapy with the potential for intra-articular injections including corticosteroids. If conservative management is unsuccessful, arthroscopic intervention with resection, refixation, or reconstruction is often considered. If conservative management is unsuccessful, arthroscopic intervention with resection, refixation, or reconstruction is often considered.

According to a recent systematic review and meta-analysis, there is promising evidence that platelet rich plasma (PRP) is an effective treatment for hip osteoarthritis. However, there is limited evidence regarding PRP treatment for ALT. To date, there is only one pilot study published evaluating 8 patients diagnosed with ALT who underwent ultrasound guided intra-articular hip injection with PRP. Optimistically, this study did reveal significant differences from baseline in function and pain scores at short term follow-up. However, the study lacked many important details including information about the injectate (the composition of the blood and PRP) which is vital to include in studies of these types. Therefore, the purpose of this study is to fully evaluate the effects of PRP treatment on the clinical outcomes of ALT prospectively in a larger cohort of patients.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah - Department of Orthopaedics
        • Contact:
        • Principal Investigator:
          • Daniel Cushman, MD
        • Sub-Investigator:
          • Derek Stokes, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≤40 years old (i.e., 18 - 40 years old)
  • Hip or groin pain with at least 1 positive provocative labral hip maneuver (i.e., Flexion, Adduction, Internal Rotation (FADIR) test, subspine impingement test, scour)
  • Radiographs with Tonnis grade < 2 (i.e., 0 or 1)
  • MRI or MRA hip with evidence of acetabular labral tear
  • Failure of at least 6 weeks of conservative management [i.e., activity modification, non-steroidal anti-inflammatory drugs (NSAIDs), and/or physical therapy (PT), other intra-articular injection etc.]
  • Prior diagnostic ultrasound guided hip injection with anesthetic-only providing ≥50% pain relief

Exclusion Criteria:

  • Any prior surgery to the affected hip
  • Imaging with evidence of avascular necrosis of the affected hip
  • Imaging with evidence of hip dysplasia (i.e. lateral center edge angle of ≤20 degrees)
  • Alpha angle of ≥55 degrees of the affected hip
  • Intra-articular hip injection within the last 6 months to the affected hip of any injectate with the exception of anesthetic
  • Active systemic infection requiring antibiotics or local infection at the site of the injection
  • Any prior intra-articular infection of the affected hip
  • Any prior fracture of the affected femur or pelvis
  • Blood dyscrasia or malignancy
  • Non-ambulatory patients
  • Patient seeking care with active litigation pending
  • Body mass index (BMI) ≥ 35 kg/m2
  • Systemic inflammatory arthropathy
  • Oral steroids consumed within the last three months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intra-Articular hip injection of PRP
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.
Biological: PRP
Intra-articular hip injection of PRP, Blood Collection 45mL, Processed Neutrophil-Poor PRP, 1 injection to one hip joint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain & Function Improvements
Time Frame: 12 Months
The primary analysis will be an improvement in Harris Hip Scores (HHS) and Visual Analog Scale (VAS) over twelve months. Descriptive statistics will be calculated for patent demographics and clinical characteristics as well as for pre-injection (baseline) and post-injection (at 1, 3, 6, and 12 months) data for VAS and HHS.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: 12 Months
VAS at 1, 3, 6, and 12 months after injection. The VAS asks "Overall, how would you rate your hip from 0 (worst possible) - 100 (best possible)".
12 Months
Harris Hip Scores (HHS)
Time Frame: 12 Months

Harris Hip Scores (HHS) at 1,3, 6, and 12 months after their injection. There are ten items covering four domains. The domains are pain, function, absence of deformity, and range of motion.

The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
12 Months
International Hip Outcome Tool (iHOT-12)
Time Frame: 12 Months

International Hip Outcome Tool (iHOT-12) at 1, 3, 6, and 12 months after their injection. The iHOT-12 consists of four domains; symptoms and functional limitations, sport and recreational activities, job-related concerns, and social, emotional, and lifestyle concerns.

Each item in the iHOT-12 was scored using a visual analog scale from 0 to 100, with a score of 100 being the best function and least amount of symptoms, and the overall mean equates to the final iHOT score.
12 Months
EQ-5D (EuroQual 5D)
Time Frame: 12 Months
EQ-5D (EuroQual 5D) at 1, 3, 6, and 12 months after their injection. The EQ-5D consists of 5 domains; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each of the 5 domains are divided into 5 levels of problems (Level 1: indicating no problems, Level 2: indicating slight problems, Level 3: indicating moderate problems, Level 4: indicating severe problems, and Level 5: indicating extreme problems). The EQ-5D also includes an overall health domain rated from 0 to 100.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Dan Cushman, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2024

Primary Completion (Estimated)

January 25, 2025

Study Completion (Estimated)

January 25, 2026

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 00173470

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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