Intra-articular Platelet-Rich Plasma for Acetabular Labral Tears
- Registration Number
- NCT06332352
- Lead Sponsor
- University of Utah
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intra-Articular hip injection of PRP 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.
- Primary Outcome Measures
Name Time Method Pain & Function Improvements 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.
- Secondary Outcome Measures
Name Time Method Visual Analog Scale (VAS) 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)".
EQ-5D (EuroQual 5D) 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.
Harris Hip Scores (HHS) 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.International Hip Outcome Tool (iHOT-12) 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.
Trial Locations
- Locations (1)
University of Utah - Department of Orthopaedics
🇺🇸Salt Lake City, Utah, United States