A Phase 4 interventional study of platelet-rich plasma injection and Kenalog 10 MG/ML Injectable Suspension in Femoroacetabular Impingement, sponsored by University of Michigan. Terminated at 1 site in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-04-03.
Sponsored by University of Michigan · Phase 4, Interventional, and Treatment
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).
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.
108 studies on the registry are indexed under Femoracetabular Impingement; 35 are open to participants now.
This study's enrollment of 4 is below the median of 75 across 63 interventional studies indexed under Femoracetabular Impingement.
Browse Femoracetabular Impingement studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
platelet-rich plasma injection into the head-neck junction of the hip joint
Drug: platelet-rich plasma injection
corticosteroid injection into the head-neck junction of the hip joint
Drug: Kenalog 10 MG/ML Injectable Suspension
platelet-rich plasma injection
Also known as: PRP
4 mL corticosteroid injection
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
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
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
Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP.
Time frame: 12 months
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
| Milestone | Platelet-rich Plasma | Kenalog 10 mg/mL Injectable Suspension |
|---|---|---|
| Started | 2 | 2 |
| Completed | 0 | 0 |
| Not completed | 2 | 2 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Platelet-rich Plasma | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Kenalog 10 mg/mL Injectable Suspension | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Platelet-rich Plasma | Kenalog 10 mg/mL Injectable Suspension | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 2 | 4 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Platelet-rich Plasma | Kenalog 10 mg/mL Injectable Suspension | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 1 | 0 | 1 |
| Race and Ethnicity Not Collected(Participants) | Platelet-rich Plasma | Kenalog 10 mg/mL Injectable Suspension | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Kellgren-Lawrence classification scores(score on a scale) | Platelet-rich Plasma | Kenalog 10 mg/mL Injectable Suspension | Total |
|---|---|---|---|
| Mean | 1 (0 to 1) | 2 (1 to 2) | 1 (0 to 2) |
| Pain as measured by Visual Analog Scale (VAS)(score on a scale) | Platelet-rich Plasma | Kenalog 10 mg/mL Injectable Suspension | Total |
|---|---|---|---|
| Mean | 53.5 (50 to 57) | 53 (40 to 66) | 53.25 (40 to 66) |
| Serum Biomarkers(pg/mL) | Platelet-rich Plasma | Kenalog 10 mg/mL Injectable Suspension | Total |
|---|---|---|---|
| IFN-g | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
| IL-6 | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
| MCP-1 | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
| MIP-1b | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
| IL-1b | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
| TNF-alpha | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
| high-sensitivity CRP | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
| COMP | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
| HOOS Hip Survey(score on a scale) | Platelet-rich Plasma | Kenalog 10 mg/mL Injectable Suspension | Total |
|---|---|---|---|
| HOOS Symptom Score | 57.5 (40 to 75) | 47.5 (45 to 50) | 52.5 (40 to 75) |
| HOOS Activities of Daily Living | 84 (72 to 96) | 61.5 (59 to 64) | 72.75 (59 to 96) |
| HOOS Sports and Recreation Score | 84.5 (81 to 88) | 45.5 (25 to 66) | 65 (25 to 88) |
| HOOS Quality of Life Score | 53.5 (44 to 63) | 23 (19 to 27) | 38.25 (19 to 63) |
| HOOS Pain Score | 72.5 (60 to 85) | 50 (45 to 55) | 61.25 (45 to 85) |
| Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale(score on a scale) | Platelet-rich Plasma | Kenalog 10 mg/mL Injectable Suspension | Total |
|---|---|---|---|
| Physical Health | 16 (15 to 17) | 16 (16 to 16) | 16 (15 to 17) |
| Mental Health | 14.5 (13 to 16) | 13 (12 to 14) | 13.75 (12 to 16) |
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