Clinical trial

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

Name
00173470
Description
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.
Trial arms
Trial start
2024-01-25
Estimated PCD
2025-01-25
Trial end
2026-01-25
Status
Recruiting
Treatment
PRP
Intra-articular hip injection of PRP, Blood Collection 45mL, Processed Neutrophil-Poor PRP, 1 injection to one hip joint.
Arms:
Intra-Articular hip injection of PRP
Size
30
Primary endpoint
Pain & Function Improvements
12 Months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-06-10

1 organization

1 product

1 indication

Organization
University of Utah
Product
PRP
Indication
labral tear