Back to resultsPlatelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement
Primary Purpose
Femoroacetabular Impingement
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
platelet-rich plasma injection
Kenalog 10 MG/ML Injectable Suspension
Sponsored by
About this trial
This is an interventional treatment trial for Femoroacetabular Impingement
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
- 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
Sites / Locations
- University of Michigan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
platelet-rich plasma
Kenalog 10 mg/mL Injectable Suspension
Arm Description
platelet-rich plasma injection into the head-neck junction of the hip joint
corticosteroid injection into the head-neck junction of the hip joint
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02920177
Brief Title
Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement
Official Title
Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
August 10, 2018 (Actual)
Study Completion Date
August 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
platelet-rich plasma
Arm Type
Experimental
Arm Description
platelet-rich plasma injection into the head-neck junction of the hip joint
Arm Title
Kenalog 10 mg/mL Injectable Suspension
Arm Type
Active Comparator
Arm Description
corticosteroid injection into the head-neck junction of the hip joint
Intervention Type
Drug
Intervention Name(s)
platelet-rich plasma injection
Other Intervention Name(s)
PRP
Intervention Description
platelet-rich plasma injection
Intervention Type
Drug
Intervention Name(s)
Kenalog 10 MG/ML Injectable Suspension
Intervention Description
4 mL corticosteroid injection
Primary Outcome Measure Information:
Title
Change From Baseline in Pain Score on the Visual Analog Scale
Description
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 Outcome Measure Information:
Title
Hip Disability and Osteoarthritis Outcome Score (HOOS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), Calculated as a Sub-score of the HOOS
Description
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
Title
Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale
Description
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
Title
Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP.
Time Frame
12 months
Title
Change in Kellgren-Lawrence Classification Scores
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tariq M Awan, DO
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement
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