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

Phase 4

Terminated

• Conditions: Femoroacetabular Impingement
• Interventions: Drug: Kenalog 10 MG/ML Injectable Suspension; Drug: platelet-rich plasma injection

• Registration Number: NCT02920177
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2016-08-01
• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-09-28
• Study First Posted: 2016-09-30
• Primary Completion: 2018-08-10
• Study Completion: 2018-08-10
• Disposition First Submitted: 2019-08-05
• Disposition First Submitted QC: 2019-08-13
• Disposition First Posted: 2019-08-19
• Status Verified: 2020-03
• Results First Submitted: 2020-03-19
• Results First Submitted QC: 2020-03-19
• Last Update Submitted: 2020-03-19
• Results First Posted: 2020-04-03
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kenalog 10 mg/mL Injectable Suspension	Kenalog 10 MG/ML Injectable Suspension	corticosteroid injection into the head-neck junction of the hip joint
platelet-rich plasma	platelet-rich plasma injection	platelet-rich plasma injection into the head-neck junction of the hip joint

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Pain Score on the Visual Analog Scale	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 Outcome Measures

Name	Time	Method
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	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.
Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale	12 months	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.
Change in Kellgren-Lawrence Classification Scores	12 months	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.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States