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

Femoroacetabular Impingement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02920177
• Other study ID #: HUM00104340
• Status: Terminated
• Phase: Phase 4
• Start date: August 1, 2016
• Est. completion date: August 10, 2018

Study information

• Verified date: March 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 10, 2018
• Est. primary completion date: August 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement

Intervention

Drug:
• platelet-rich plasma injection
platelet-rich plasma injection
• Kenalog 10 MG/ML Injectable Suspension
4 mL corticosteroid injection

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP.		12 months
Secondary	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