Acetabular Labrum Tear
Conditions
Keywords
Acetabular Labrum Tear, Platelet Rich Plasma
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.
Interventions
BIOLOGICALPRP
Intra-articular hip injection of PRP, Blood Collection 45mL, Processed Neutrophil-Poor PRP, 1 injection to one hip joint.
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Assessment Score | 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. |
| International Hip Outcome Tool (iHOT-12) | 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. |
| EQ VAS (EuroQual Visual Analog Scale) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDan Cushman, MD
University of Utah
Participant flow
Recruitment details
Patients were recruited from March through December 2024. Patients were clinically diagnosed with a symptomatic acetabular labral tear by a primary care or orthopedic sports medicine physician in a tertiary outpatient, orthopedic clinic setting. Patients who met inclusion criteria were referred to the study and given the option of participation.
Pre-assignment details
This was an open-label study; therefore, no randomization was performed. In some cases, participants had more than one hip enrolled, accounting for the difference between the number of participants (n=28) and the number of units/hips enrolled (n=30).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 37 Years |
| BMI | 24 kg/m^2 |
| Duration of symptoms | 12 Months |
| EQ VAS (EuroQual Visual Analog Scale) | 68 score on a scale |
| Global Assessment Score | 51 score on a scale |
| International Hip Outcome Tool (iHOT-12) | 50.5 score on a scale |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 16 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
None listed