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Completed

NCT Number: NCT06332352

Intra-articular Platelet-Rich Plasma for Acetabular Labral Tears

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.

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah - Department of Orthopaedics

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≤49 years old (i.e., 18 - 49 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

Treatment and study plan

PRP

Biological

Intra-articular hip injection of PRP, Blood Collection 45mL, Processed Neutrophil-Poor PRP, 1 injection to one hip joint.

Primary outcomes

  1. Global Assessment Score

    Time frame: 6 Months

    Global patient satisfaction was assessed prospectively at 6 months following the intervention using a numeric rating scale ranging from 0 to 100.

    Participants were asked to rate their hip, where 0 represented "worst possible" and 100 represented "best possible."

    The score reflects the participant's overall perception of their injection, including symptom improvement and overall experience.

  2. International Hip Outcome Tool (iHOT-12)

    Time frame: 6 Months

    Description:

    The International Hip Outcome Tool-12 (iHOT-12) is a validated, patient-reported outcome measure designed to assess symptoms, functional limitations, and quality of life in young, active individuals with hip disorders.

    Structure:

    The iHOT-12 consists of 12 items that capture four domains:

    Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns

    Each item is presented as a visual analog scale (VAS).

    Scoring:

    Each item is scored from 0 to 100. 0 = severe symptoms/extreme limitations 100 = no symptoms/no limitations

    The overall score is calculated as the mean of all answered items (range 0-100), with higher scores indicating better hip function and quality of life.

  3. EQ VAS (EuroQual Visual Analog Scale)

    Time frame: 6 Months

    The EQ Visual Analog Scale (EQ VAS) was used to assess participants' self-rated overall health at the primary end-point. Participants rated their health on a scale from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health. Higher scores indicate better perceived health status.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Acronym: PRP for ALT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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