Trial Outcomes & Findings for Effect of Different Injection Regimens of Autologous Conditioned Plasma for Knee Osteoarthritis (NCT NCT03889925)
NCT ID: NCT03889925
Last Updated: 2025-02-24
Results Overview
Patient reported outcome measure; The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total score. Higher scores indicate worse pain, stiffness, and functional limitations.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
64 participants
Primary outcome timeframe
Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injections
Results posted on
2025-02-24
Participant Flow
Participant milestones
| Measure |
Autologous Conditioned Plasma Group
Participants in this group will receive a three-injection series of autologous conditioned plasma over the course of 3 consecutive weeks.
Autologous conditioned plasma: Patients will receive 3 intra-articular injections of autologous conditioned plasma dosed at once a week for 3 weeks.
|
Autologous Conditioned Plasma With Hyaluronic Acid Group
Participants in this group will receive a two-injection series of autologous conditioned plasma and hyaluronic acid (Hymovis, Fidia Pharmaceuticals) and a third injection on the third week of autologous conditioned plasma.
Hyaluronan: Patients will receive 2 intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for 2 weeks and a third injection on the third week of ACP.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
| Measure |
Autologous Conditioned Plasma Group
Participants in this group will receive a three-injection series of autologous conditioned plasma over the course of 3 consecutive weeks.
Autologous conditioned plasma: Patients will receive 3 intra-articular injections of autologous conditioned plasma dosed at once a week for 3 weeks.
|
Autologous Conditioned Plasma With Hyaluronic Acid Group
Participants in this group will receive a two-injection series of autologous conditioned plasma and hyaluronic acid (Hymovis, Fidia Pharmaceuticals) and a third injection on the third week of autologous conditioned plasma.
Hyaluronan: Patients will receive 2 intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for 2 weeks and a third injection on the third week of ACP.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
10
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Autologous Conditioned Plasma Group
n=32 Participants
Participants in this group will receive a three-injection series of autologous conditioned plasma over the course of 3 consecutive weeks.
Autologous conditioned plasma: Patients will receive 3 intra-articular injections of autologous conditioned plasma dosed at once a week for 3 weeks.
|
Autologous Conditioned Plasma With Hyaluronic Acid Group
n=32 Participants
Participants in this group will receive a two-injection series of autologous conditioned plasma and hyaluronic acid (Hymovis, Fidia Pharmaceuticals) and a third injection on the third week of autologous conditioned plasma.
Hyaluronan: Patients will receive 2 intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for 2 weeks and a third injection on the third week of ACP.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 11.4 • n=32 Participants
|
60.7 years
STANDARD_DEVIATION 9 • n=32 Participants
|
58.25 years
STANDARD_DEVIATION 9.79 • n=64 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=32 Participants
|
16 Participants
n=32 Participants
|
35 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=32 Participants
|
16 Participants
n=32 Participants
|
29 Participants
n=64 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
IKDC
|
39.2 Score
STANDARD_DEVIATION 10.4 • n=32 Participants
|
38.6 Score
STANDARD_DEVIATION 14.5 • n=32 Participants
|
38.9 Score
STANDARD_DEVIATION 12.52 • n=64 Participants
|
|
WOMAC
|
40 Score
STANDARD_DEVIATION 18.6 • n=32 Participants
|
40.5 Score
STANDARD_DEVIATION 18.7 • n=32 Participants
|
40.25 Score
STANDARD_DEVIATION 18.5 • n=64 Participants
|
|
KOOS
|
42.7 Score
STANDARD_DEVIATION 12.7 • n=32 Participants
|
44.3 Score
STANDARD_DEVIATION 14.4 • n=32 Participants
|
43.5 Score
STANDARD_DEVIATION 13.49 • n=64 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injectionsPatient reported outcome measure; The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total score. Higher scores indicate worse pain, stiffness, and functional limitations.
Outcome measures
| Measure |
Autologous Conditioned Plasma Group
n=32 Participants
Participants in this group will receive a three-injection series of autologous conditioned plasma over the course of 3 consecutive weeks.
Autologous conditioned plasma: Patients will receive 3 intra-articular injections of autologous conditioned plasma dosed at once a week for 3 weeks.
|
Autologous Conditioned Plasma With Hyaluronic Acid Group
n=32 Participants
Participants in this group will receive a two-injection series of autologous conditioned plasma and hyaluronic acid (Hymovis, Fidia Pharmaceuticals) and a third injection on the third week of autologous conditioned plasma.
Hyaluronan: Patients will receive 2 intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for 2 weeks and a third injection on the third week of ACP.
|
|---|---|---|
|
Western Ontario and McMaster University's Osteoarthritis Index (WOMAC)
1 Month
|
24.9 score on a scale
Standard Deviation 15.6
|
22.4 score on a scale
Standard Deviation 15.2
|
|
Western Ontario and McMaster University's Osteoarthritis Index (WOMAC)
3 Months
|
26.1 score on a scale
Standard Deviation 20.1
|
22.3 score on a scale
Standard Deviation 16.3
|
|
Western Ontario and McMaster University's Osteoarthritis Index (WOMAC)
6 Months
|
21.9 score on a scale
Standard Deviation 15.3
|
22.5 score on a scale
Standard Deviation 16.5
|
|
Western Ontario and McMaster University's Osteoarthritis Index (WOMAC)
12 Months
|
25.9 score on a scale
Standard Deviation 18.7
|
22.7 score on a scale
Standard Deviation 19.3
|
|
Western Ontario and McMaster University's Osteoarthritis Index (WOMAC)
18 Months
|
21 score on a scale
Standard Deviation 15.1
|
27.1 score on a scale
Standard Deviation 23.8
|
|
Western Ontario and McMaster University's Osteoarthritis Index (WOMAC)
24 Months
|
26.7 score on a scale
Standard Deviation 17.8
|
29.2 score on a scale
Standard Deviation 23.3
|
PRIMARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injectionsPatient reported outcome measure; Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Outcome measures
| Measure |
Autologous Conditioned Plasma Group
n=32 Participants
Participants in this group will receive a three-injection series of autologous conditioned plasma over the course of 3 consecutive weeks.
Autologous conditioned plasma: Patients will receive 3 intra-articular injections of autologous conditioned plasma dosed at once a week for 3 weeks.
|
Autologous Conditioned Plasma With Hyaluronic Acid Group
n=32 Participants
Participants in this group will receive a two-injection series of autologous conditioned plasma and hyaluronic acid (Hymovis, Fidia Pharmaceuticals) and a third injection on the third week of autologous conditioned plasma.
Hyaluronan: Patients will receive 2 intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for 2 weeks and a third injection on the third week of ACP.
|
|---|---|---|
|
International Knee Documentation Committee Subjective Knee Evaluation Form
1 Month
|
50.1 score on a scale
Standard Deviation 17.3
|
53.7 score on a scale
Standard Deviation 14.1
|
|
International Knee Documentation Committee Subjective Knee Evaluation Form
3 Months
|
50.4 score on a scale
Standard Deviation 17.6
|
56.9 score on a scale
Standard Deviation 17.6
|
|
International Knee Documentation Committee Subjective Knee Evaluation Form
6 Months
|
53.1 score on a scale
Standard Deviation 16
|
53.1 score on a scale
Standard Deviation 19.9
|
|
International Knee Documentation Committee Subjective Knee Evaluation Form
12 Months
|
50.6 score on a scale
Standard Deviation 19.1
|
55.7 score on a scale
Standard Deviation 21.5
|
|
International Knee Documentation Committee Subjective Knee Evaluation Form
18 Months
|
57 score on a scale
Standard Deviation 23.6
|
53.4 score on a scale
Standard Deviation 24.5
|
|
International Knee Documentation Committee Subjective Knee Evaluation Form
24 Months
|
50.9 score on a scale
Standard Deviation 20.1
|
51.8 score on a scale
Standard Deviation 21.9
|
PRIMARY outcome
Timeframe: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injectionsPatient reported outcome measure; A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated.
Outcome measures
| Measure |
Autologous Conditioned Plasma Group
n=32 Participants
Participants in this group will receive a three-injection series of autologous conditioned plasma over the course of 3 consecutive weeks.
Autologous conditioned plasma: Patients will receive 3 intra-articular injections of autologous conditioned plasma dosed at once a week for 3 weeks.
|
Autologous Conditioned Plasma With Hyaluronic Acid Group
n=32 Participants
Participants in this group will receive a two-injection series of autologous conditioned plasma and hyaluronic acid (Hymovis, Fidia Pharmaceuticals) and a third injection on the third week of autologous conditioned plasma.
Hyaluronan: Patients will receive 2 intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for 2 weeks and a third injection on the third week of ACP.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score
1 Month
|
59.4 score
Standard Deviation 13.5
|
62.7 score
Standard Deviation 12.5
|
|
Knee Injury and Osteoarthritis Outcome Score
3 Months
|
59 score
Standard Deviation 18.8
|
62.9 score
Standard Deviation 20.5
|
|
Knee Injury and Osteoarthritis Outcome Score
6 months
|
64.2 score
Standard Deviation 16.3
|
62.5 score
Standard Deviation 18.1
|
|
Knee Injury and Osteoarthritis Outcome Score
12 Months
|
61.8 score
Standard Deviation 17.7
|
61.8 score
Standard Deviation 20.4
|
|
Knee Injury and Osteoarthritis Outcome Score
18 Months
|
65.3 score
Standard Deviation 18.2
|
59.8 score
Standard Deviation 19.5
|
|
Knee Injury and Osteoarthritis Outcome Score
24 Months
|
59.8 score
Standard Deviation 19.5
|
59 score
Standard Deviation 24.4
|
Adverse Events
Autologous Conditioned Plasma Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Autologous Conditioned Plasma With Hyaluronic Acid 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