Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement

Phase 4TerminatedNCT02920177

University of Michigan4 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Femoroacetabular Impingement

Interventions

platelet-rich plasma injectionDRUG

platelet-rich plasma injection

Kenalog 10 MG/ML Injectable SuspensionDRUG

4 mL corticosteroid injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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 * Patients with abnormal hematology or serum chemistry lab results * Patients receiving injection to treatment knee within 2 months of study enrollment * BMI greater than 35 or less than 20

Locations (1)

University of Michigan Hospital

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Change From Baseline in Pain Score on the Visual Analog Scale

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.

Time frame: 12 months

Secondary Outcomes

Hip Disability and Osteoarthritis Outcome Score (HOOS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), Calculated as a Sub-score of the HOOS

Measure Description: Hip Disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome. The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome. The questions that are included in the WOMAC are a subgroup of questions that are included in the HOOS, so because of this the HOOS survey can also be used to calculate the WOMAC score for patients.

Time frame: 12 months

Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale

Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Global physical health measures overall physical health, physical function, pain and fatigue. Physical global health scores range from 0 - 100, and higher scores indicate better physical health.

Time frame: 12 months

Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP.

Data from ClinicalTrials.gov

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