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low enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| platelet-rich plasma | Experimental | platelet-rich plasma injection into the head-neck junction of the hip joint |
|
| Kenalog 10 mg/mL Injectable Suspension | Active Comparator | corticosteroid injection into the head-neck junction of the hip joint |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| platelet-rich plasma injection | Drug | platelet-rich plasma injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tariq M Awan, DO | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Platelet-rich Plasma | platelet-rich plasma injection into the head-neck junction of the hip joint |
| FG001 | Kenalog 10 mg/mL Injectable Suspension | corticosteroid injection into the head-neck junction of the hip joint |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Platelet-rich Plasma | platelet-rich plasma injection into the head-neck junction of the hip joint |
| BG001 | Kenalog 10 mg/mL Injectable Suspension | corticosteroid injection into the head-neck junction of the hip joint |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up. | Posted | 12 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Platelet-rich Plasma | platelet-rich plasma injection into the head-neck junction of the hip joint |
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Recruitment was supposed to take place in the first year, but was extended due to low enrollment. The study was terminated early due to an inability to enroll subjects. All participants left the study before outcome measure data could be collected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordyn Sessel | University of Michigan | 734-615-0934 | jsessel@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 12, 2018 | Jan 29, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057925 | Femoracetabular Impingement |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Kenalog 10 MG/ML Injectable Suspension | Drug | 4 mL corticosteroid injection |
|
| 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. | 12 months |
| 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 | 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 |
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Kellgren-Lawrence classification scores | Kellgren Lawrence grading system will 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. | Mean | Full Range | score on a scale |
|
| Pain as measured by Visual Analog Scale (VAS) | 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. | Mean | Full Range | score on a scale |
|
| Serum Biomarkers | Mean | Full Range | pg/mL |
|
| HOOS Hip Survey | Hip Disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is scored separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome. | Mean | Full Range | score on a scale |
|
| Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale | 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. 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. | Mean | Full Range | score on a scale |
|
|
| 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. | No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up. | Posted | 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. | No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up. | Posted | 12 months |
|
|
| Secondary | Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP. | No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up. | Posted | 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. | No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up. | Posted | 12 months |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Kenalog 10 mg/mL Injectable Suspension | corticosteroid injection into the head-neck junction of the hip joint | 0 | 2 | 0 | 2 | 0 | 2 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |