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

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).

Study Overview

• Status: Terminated
• Conditions: Femoroacetabular Impingement
• Intervention / Treatment: Drug: platelet-rich plasma injection; Drug: Kenalog 10 MG/ML Injectable Suspension

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: platelet-rich plasma; platelet-rich plasma injection into the head-neck junction of the hip joint	Drug: platelet-rich plasma injection; platelet-rich plasma injection; Other Names: PRP
Active Comparator: Kenalog 10 mg/mL Injectable Suspension; corticosteroid injection into the head-neck junction of the hip joint	Drug: Kenalog 10 MG/ML Injectable Suspension; 4 mL corticosteroid injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12 months
Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP.		12 months
Change in Kellgren-Lawrence Classification Scores	Calculated from anterior-posterior (AP) pelvis radiographs. Kellgren Lawrence grading system was intended to be utilized analyzing pre-treatment and post-treatment radiographs of the knee. Grading is from 1 to 4 with 1 being minimal to mild disease and 4 being end stage joint disease.	12 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Tariq M Awan, DO, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): August 10, 2018
• Study Completion (Actual): August 10, 2018

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Femoracetabular Impingement; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone Acetonide
• Other Study ID Numbers: HUM00104340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No