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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02920177
Other study ID # HUM00104340
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
See also
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