Trial Outcomes & Findings for Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears (NCT NCT04088227)
NCT ID: NCT04088227
Last Updated: 2025-02-17
Results Overview
The presence of the Synovial Interleukin (IL) -1 Receptor Antagonist biomarker in the synovial fluid will be assessed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Timepoint 1: initial visit (within 10 days of injury) Timepoint 2: at the time of surgery (within 4 weeks of injury)
Results posted on
2025-02-17
Participant Flow
Participant milestones
| Measure |
Control Group
The control group will have a joint aspiration performed at an initial visit (within the first 10 days after injury), and at the time of surgery (within 4 weeks of injury).
Control Group: Patients will have their knee aspirated at their initial physician visit and at the time of surgery.
|
Experimental Group
The experimental group will have a joint aspiration performed at an initial visit (within the first 10 days after injury) and receive an injection of leukocyte poor platelet rich plasma injection in their knee. At a second visit 5-12 days after the initial visit, the patient will receive a joint aspiration and platelet rich plasma injection. A final joint aspiration will be performed at the time of surgery (within 4 weeks of injury).
Experimental Group: Patients will receive platelet rich plasma injection two times prior to surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Control Group
The control group will have a joint aspiration performed at an initial visit (within the first 10 days after injury), and at the time of surgery (within 4 weeks of injury).
Control Group: Patients will have their knee aspirated at their initial physician visit and at the time of surgery.
|
Experimental Group
The experimental group will have a joint aspiration performed at an initial visit (within the first 10 days after injury) and receive an injection of leukocyte poor platelet rich plasma injection in their knee. At a second visit 5-12 days after the initial visit, the patient will receive a joint aspiration and platelet rich plasma injection. A final joint aspiration will be performed at the time of surgery (within 4 weeks of injury).
Experimental Group: Patients will receive platelet rich plasma injection two times prior to surgery.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Surgery postponed >5weeks
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=12 Participants
The control group will have a joint aspiration performed at an initial visit (within the first 10 days after injury), and at the time of surgery (within 4 weeks of injury).
Control Group: Patients will have their knee aspirated at their initial physician visit and at the time of surgery.
|
Experimental Group
n=12 Participants
The experimental group will have a joint aspiration performed at an initial visit (within the first 10 days after injury) and receive an injection of leukocyte poor platelet rich plasma injection in their knee. At a second visit 5-12 days after the initial visit, the patient will receive a joint aspiration and platelet rich plasma injection. A final joint aspiration will be performed at the time of surgery (within 4 weeks of injury).
Experimental Group: Patients will receive platelet rich plasma injection two times prior to surgery.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.4 years
STANDARD_DEVIATION 8 • n=12 Participants
|
20 years
STANDARD_DEVIATION 6.7 • n=12 Participants
|
20 years
STANDARD_DEVIATION 7.7 • n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
8 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
16 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight
|
87.6 kg
STANDARD_DEVIATION 26.7 • n=12 Participants
|
68.5 kg
STANDARD_DEVIATION 12.8 • n=12 Participants
|
80.8 kg
STANDARD_DEVIATION 21.56 • n=24 Participants
|
|
Height
|
173 cm
STANDARD_DEVIATION 11.5 • n=12 Participants
|
174.6 cm
STANDARD_DEVIATION 8.3 • n=12 Participants
|
174.6 cm
STANDARD_DEVIATION 11.63 • n=24 Participants
|
|
BMI
|
29.1 kg/m^2
STANDARD_DEVIATION 6.8 • n=12 Participants
|
22.5 kg/m^2
STANDARD_DEVIATION 4 • n=12 Participants
|
26.2 kg/m^2
STANDARD_DEVIATION 6.48 • n=24 Participants
|
|
Time to Surgery (days)
|
16.9 days
STANDARD_DEVIATION 6.8 • n=12 Participants
|
27 days
STANDARD_DEVIATION 13.1 • n=12 Participants
|
20.74 days
STANDARD_DEVIATION 9.34 • n=24 Participants
|
PRIMARY outcome
Timeframe: Timepoint 1: initial visit (within 10 days of injury) Timepoint 2: at the time of surgery (within 4 weeks of injury)The presence of the Synovial Interleukin (IL) -1 Receptor Antagonist biomarker in the synovial fluid will be assessed.
Outcome measures
| Measure |
Control Group
n=12 Participants
The control group will have a joint aspiration performed at an initial visit (within the first 10 days after injury), and at the time of surgery (within 4 weeks of injury).
Control Group: Patients will have their knee aspirated at their initial physician visit and at the time of surgery.
|
Experimental Group
n=12 Participants
The experimental group will have a joint aspiration performed at an initial visit (within the first 10 days after injury) and receive an injection of leukocyte poor platelet rich plasma injection in their knee. At a second visit 5-12 days after the initial visit, the patient will receive a joint aspiration and platelet rich plasma injection. A final joint aspiration will be performed at the time of surgery (within 4 weeks of injury).
Experimental Group: Patients will receive platelet rich plasma injection two times prior to surgery.
|
|---|---|---|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IL-1ß Timepoint 1
|
13.8 pg/ml
Standard Deviation 4.1
|
16 pg/ml
Standard Deviation 4.9
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IL-1ß Timepoint 2
|
9.9 pg/ml
Standard Deviation 4.9
|
7.5 pg/ml
Standard Deviation 4.5
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IL-10 Timepoint 1
|
53.1 pg/ml
Standard Deviation 16.4
|
64.3 pg/ml
Standard Deviation 21.4
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IL-10 Timepoint 2
|
36.1 pg/ml
Standard Deviation 20.3
|
31.7 pg/ml
Standard Deviation 19.2
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IL-6 Timepoint 1
|
7668.6 pg/ml
Standard Deviation 4092.9
|
8650.8 pg/ml
Standard Deviation 3983.9
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IL-6 Timepoint 2
|
3940.2 pg/ml
Standard Deviation 3809.2
|
2196.2 pg/ml
Standard Deviation 2994.2
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
GM- CSF Timepoint 1
|
20.6 pg/ml
Standard Deviation 7.1
|
25.3 pg/ml
Standard Deviation 9.1
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
GM- CSF Timepoint 2
|
16 pg/ml
Standard Deviation 10.1
|
12.4 pg/ml
Standard Deviation 9.5
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IL-5 Timepoint 1
|
30.6 pg/ml
Standard Deviation 16.7
|
48.8 pg/ml
Standard Deviation 23.9
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IL-5 Timepoint 2
|
27.9 pg/ml
Standard Deviation 23.3
|
24.7 pg/ml
Standard Deviation 19.7
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IFN-γ Timepoint 1
|
2.5 pg/ml
Standard Deviation 1.1
|
4.0 pg/ml
Standard Deviation 1.7
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IFN-γ Timepoint 2
|
2.6 pg/ml
Standard Deviation 1.5
|
1.7 pg/ml
Standard Deviation 1.3
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
TNF-⍺ Timepoint 1
|
11.2 pg/ml
Standard Deviation 7.0
|
21.6 pg/ml
Standard Deviation 9.5
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
TNF-⍺ Timepoint 2
|
10.4 pg/ml
Standard Deviation 9.1
|
10.9 pg/ml
Standard Deviation 7.9
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IL-2 Timepoint 1
|
29.2 pg/ml
Standard Deviation 24.9
|
54.6 pg/ml
Standard Deviation 34.3
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IL-2 Timepoint 2
|
32.7 pg/ml
Standard Deviation 32.5
|
28.6 pg/ml
Standard Deviation 25.9
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IL-4 Timepoint 1
|
278.2 pg/ml
Standard Deviation 144.4
|
398.5 pg/ml
Standard Deviation 189.4
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IL-4 Timepoint 2
|
234.5 pg/ml
Standard Deviation 161.6
|
200.2 pg/ml
Standard Deviation 167.7
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IL-8 Timepoint 1
|
315.1 pg/ml
Standard Deviation 80.3
|
1295.2 pg/ml
Standard Deviation 1075.9
|
|
Change in Synovial Interleukin (IL) -1 Receptor Antagonist Concentration
IL-8 Timepoint 2
|
124.8 pg/ml
Standard Deviation 49.7
|
222.6 pg/ml
Standard Deviation 113.4
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Research
Andrews Research & Education Foundation
Phone: 8509168570
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place