Femoroacetabular Impingement
Conditions
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.
Interventions
platelet-rich plasma injection
DRUGKenalog 10 MG/ML Injectable Suspension
4 mL corticosteroid injection
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP. | 12 months | — |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Platelet-rich Plasma platelet-rich plasma injection into the head-neck junction of the hip joint | 2 |
| Kenalog 10 mg/mL Injectable Suspension corticosteroid injection into the head-neck junction of the hip joint | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Platelet-rich Plasma | Kenalog 10 mg/mL Injectable Suspension | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| HOOS Hip Survey HOOS Activities of Daily Living | 84 score on a scale | 61.5 score on a scale | 72.75 score on a scale |
| HOOS Hip Survey HOOS Pain Score | 72.5 score on a scale | 50 score on a scale | 61.25 score on a scale |
| HOOS Hip Survey HOOS Quality of Life Score | 53.5 score on a scale | 23 score on a scale | 38.25 score on a scale |
| HOOS Hip Survey HOOS Sports and Recreation Score | 84.5 score on a scale | 45.5 score on a scale | 65 score on a scale |
| HOOS Hip Survey HOOS Symptom Score | 57.5 score on a scale | 47.5 score on a scale | 52.5 score on a scale |
| Kellgren-Lawrence classification scores | 1 score on a scale | 2 score on a scale | 1 score on a scale |
| Pain as measured by Visual Analog Scale (VAS) | 53.5 score on a scale | 53 score on a scale | 53.25 score on a scale |
| Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale Mental Health | 14.5 score on a scale | 13 score on a scale | 13.75 score on a scale |
| Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale Physical Health | 16 score on a scale | 16 score on a scale | 16 score on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Serum Biomarkers COMP | NA pg/mL | NA pg/mL | NA pg/mL |
| Serum Biomarkers high-sensitivity CRP | NA pg/mL | NA pg/mL | NA pg/mL |
| Serum Biomarkers IFN-g | NA pg/mL | NA pg/mL | NA pg/mL |
| Serum Biomarkers IL-1b | NA pg/mL | NA pg/mL | NA pg/mL |
| Serum Biomarkers IL-6 | NA pg/mL | NA pg/mL | NA pg/mL |
| Serum Biomarkers MCP-1 | NA pg/mL | NA pg/mL | NA pg/mL |
| Serum Biomarkers MIP-1b | NA pg/mL | NA pg/mL | NA pg/mL |
| Serum Biomarkers TNF-alpha | NA pg/mL | NA pg/mL | NA pg/mL |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
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.
Time frame: 12 months
Population: No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.
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.
Time frame: 12 months
Population: No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.
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.
Time frame: 12 months
Population: No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.
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.
Time frame: 12 months
Population: No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.
Secondary
Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP.
Time frame: 12 months
Population: No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.