- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02920177
Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
platelet-rich plasma injection
Other Names:
|
Active Comparator: Kenalog 10 mg/mL Injectable Suspension
corticosteroid injection into the head-neck junction of the hip joint
|
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
Time Frame: 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.
|
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
Time Frame: 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. |
12 months
|
Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale
Time Frame: 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. |
12 months
|
Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP.
Time Frame: 12 months
|
12 months
|
|
Change in Kellgren-Lawrence Classification Scores
Time Frame: 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.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tariq M Awan, DO, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00104340
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Femoroacetabular Impingement
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Ottawa Hospital Research InstituteCompleted
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Schulthess KlinikCompletedSymptomatic Femoroacetabular ImpingementSwitzerland
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Ottawa Hospital Research InstituteCompletedFemoroacetabular Hip Impingement SyndromeCanada
-
Ramsay Générale de SantéRamsay santéRecruiting
-
Horsens HospitalUniversity of Aarhus; La Trobe UniversityNot yet recruitingFemoroacetabular Impingement
-
American Hip InstituteStryker OrthopaedicsRecruitingFemoroacetabular ImpingementUnited States
-
Hospital for Special Surgery, New YorkNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)RecruitingFemoroacetabular ImpingementUnited States
-
Universitaire Ziekenhuizen KU LeuvenActive, not recruitingFemoroacetabular ImpingementBelgium
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McMaster UniversityCanadian Institutes of Health Research (CIHR); McMaster Surgical Association; Arthroscopy Association of North America and other collaboratorsActive, not recruitingFemoroacetabular ImpingementCanada, Netherlands, Korea, Republic of
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The Hawkins FoundationTerminated
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