Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement
Overview
- Phase
- Phase 4
- Intervention
- platelet-rich plasma injection
- Conditions
- Femoroacetabular Impingement
- Sponsor
- University of Michigan
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Pain Score on the Visual Analog Scale
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to compare the clinical response of intra-articular platelet rich plasma (PRP) versus corticosteroid injection in patients affected by femoroacetabular impingement (FAI).
Detailed Description
This study will determine if PRP treatment of FAI improves (i) patient reported outcome scores and (ii) hip functional stability compared to standard corticosteroid treatment and if PRP treatment of FAI reduces (i) radiographic and (ii) biochemical markers of joint inflammation and cartilage degradation.
Investigators
Tariq Awan
Assistant Professor in Orthopaedic Surgery
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •Patients with symptomatic FAI
- •Clinical and radiographic evidence of FAI
- •Patients able to provide consent to study participation
- •Completion of 6 weeks of physical therapy program
Exclusion Criteria
- •Established Osteoarthritis (Kellgren-Lawrence \> 3)
- •Minimum joint space \> 2 mm as measured on AP radiograph
- •Hip dysplasia (center edge angle \< 20° on AP radiograph)
- •Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer or diabetes
- •Patients with ongoing infection including HIV and Hepatitis
- •Patient with history of osteomyelitis/septic arthritis
- •Anticoagulation therapy
- •Patients who are pregnant or breast feeding
- •Patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis
- •Patients taking immunosuppressant medication
Arms & Interventions
platelet-rich plasma
platelet-rich plasma injection into the head-neck junction of the hip joint
Intervention: platelet-rich plasma injection
Kenalog 10 mg/mL Injectable Suspension
corticosteroid injection into the head-neck junction of the hip joint
Intervention: Kenalog 10 MG/ML Injectable Suspension
Outcomes
Primary Outcomes
Change From Baseline in Pain Score on the Visual Analog Scale
Time Frame: 12 months
VAS score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Secondary Outcomes
- Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP.(12 months)
- Hip Disability and Osteoarthritis Outcome Score (HOOS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), Calculated as a Sub-score of the HOOS(12 months)
- Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale(12 months)
- Change in Kellgren-Lawrence Classification Scores(12 months)