Trial Outcomes & Findings for Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement (NCT NCT02920177)
NCT ID: NCT02920177
Last Updated: 2020-04-03
Results Overview
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.
TERMINATED
PHASE4
4 participants
12 months
2020-04-03
Participant Flow
Participant milestones
| Measure |
Platelet-rich Plasma
platelet-rich plasma injection into the head-neck junction of the hip joint
|
Kenalog 10 mg/mL Injectable Suspension
corticosteroid injection into the head-neck junction of the hip joint
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Platelet-rich Plasma
platelet-rich plasma injection into the head-neck junction of the hip joint
|
Kenalog 10 mg/mL Injectable Suspension
corticosteroid injection into the head-neck junction of the hip joint
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Platelet-rich Plasma
n=2 Participants
platelet-rich plasma injection into the head-neck junction of the hip joint
|
Kenalog 10 mg/mL Injectable Suspension
n=2 Participants
corticosteroid injection into the head-neck junction of the hip joint
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Kellgren-Lawrence classification scores
|
1 score on a scale
n=2 Participants
|
2 score on a scale
n=2 Participants
|
1 score on a scale
n=4 Participants
|
|
Pain as measured by Visual Analog Scale (VAS)
|
53.5 score on a scale
n=2 Participants
|
53 score on a scale
n=2 Participants
|
53.25 score on a scale
n=4 Participants
|
|
Serum Biomarkers
IFN-g
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=4 Participants
|
|
Serum Biomarkers
IL-6
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=4 Participants
|
|
Serum Biomarkers
MCP-1
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=4 Participants
|
|
Serum Biomarkers
MIP-1b
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=4 Participants
|
|
Serum Biomarkers
IL-1b
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=4 Participants
|
|
Serum Biomarkers
TNF-alpha
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=4 Participants
|
|
Serum Biomarkers
high-sensitivity CRP
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=4 Participants
|
|
Serum Biomarkers
COMP
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=2 Participants
|
NA pg/mL
n=4 Participants
|
|
HOOS Hip Survey
HOOS Symptom Score
|
57.5 score on a scale
n=2 Participants
|
47.5 score on a scale
n=2 Participants
|
52.5 score on a scale
n=4 Participants
|
|
HOOS Hip Survey
HOOS Activities of Daily Living
|
84 score on a scale
n=2 Participants
|
61.5 score on a scale
n=2 Participants
|
72.75 score on a scale
n=4 Participants
|
|
HOOS Hip Survey
HOOS Sports and Recreation Score
|
84.5 score on a scale
n=2 Participants
|
45.5 score on a scale
n=2 Participants
|
65 score on a scale
n=4 Participants
|
|
HOOS Hip Survey
HOOS Quality of Life Score
|
53.5 score on a scale
n=2 Participants
|
23 score on a scale
n=2 Participants
|
38.25 score on a scale
n=4 Participants
|
|
HOOS Hip Survey
HOOS Pain Score
|
72.5 score on a scale
n=2 Participants
|
50 score on a scale
n=2 Participants
|
61.25 score on a scale
n=4 Participants
|
|
Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale
Physical Health
|
16 score on a scale
n=2 Participants
|
16 score on a scale
n=2 Participants
|
16 score on a scale
n=4 Participants
|
|
Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale
Mental Health
|
14.5 score on a scale
n=2 Participants
|
13 score on a scale
n=2 Participants
|
13.75 score on a scale
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.
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.
Outcome measures
Outcome data not reported
Adverse Events
Platelet-rich Plasma
Kenalog 10 mg/mL Injectable Suspension
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place