Trial Outcomes & Findings for Platelet-Rich Plasma Intra-Articular Injection in Treating Hemophilic Arthropathy (NCT NCT02601170)
NCT ID: NCT02601170
Last Updated: 2020-09-17
Results Overview
The pain intensity will be evaluated subjectively on a visual analogue scale (0-10). Higher scores mean a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
baseline, 1 month, 2 months, 3 months, 6 months
Results posted on
2020-09-17
Participant Flow
Participant milestones
| Measure |
PRP Group
single intra-articular injection of 2mL PRP (RegentKit-THT-1, RegenLab SA, Mont-sur-Lausanne, Switzerland)
Platelet-Rich Plasma Intra-Articular Injection
|
HA Group
five weekly intra-articular injections of 2.5 mL of hyaluronate sodium (ARTZDispo, Seikagaku Corporation Japan).
Hyaluronic Acid Viscosupplementation
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Platelet-Rich Plasma Intra-Articular Injection in Treating Hemophilic Arthropathy
Baseline characteristics by cohort
| Measure |
PRP Group
n=11 Participants
single intra-articular injection of 2mL PRP (RegentKit-THT-1, RegenLab SA, Mont-sur-Lausanne, Switzerland)
Platelet-Rich Plasma Intra-Articular Injection
|
HA Group
n=11 Participants
five weekly intra-articular injections of 2.5 mL of hyaluronate sodium (ARTZDispo, Seikagaku Corporation Japan).
Hyaluronic Acid Viscosupplementation
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
40.1 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 1 month, 2 months, 3 months, 6 monthsThe pain intensity will be evaluated subjectively on a visual analogue scale (0-10). Higher scores mean a worse outcome.
Outcome measures
| Measure |
PRP Group
n=11 Participants
single intra-articular injection of 2mL PRP (RegentKit-THT-1, RegenLab SA, Mont-sur-Lausanne, Switzerland)
Platelet-Rich Plasma Intra-Articular Injection
|
HA Group
n=11 Participants
five weekly intra-articular injections of 2.5 mL of hyaluronate sodium (ARTZDispo, Seikagaku Corporation Japan).
Hyaluronic Acid Viscosupplementation
|
|---|---|---|
|
Pain (Visual Analogue Scale) and Change From Baseline at 1, 2, 3 &6 Months
Baseline
|
5.0 scores on a scale
Standard Error 0.6
|
4.1 scores on a scale
Standard Error 0.5
|
|
Pain (Visual Analogue Scale) and Change From Baseline at 1, 2, 3 &6 Months
1 month
|
2.5 scores on a scale
Standard Error 0.8
|
1.8 scores on a scale
Standard Error 0.5
|
|
Pain (Visual Analogue Scale) and Change From Baseline at 1, 2, 3 &6 Months
2 months
|
2.4 scores on a scale
Standard Error 0.8
|
1.6 scores on a scale
Standard Error 0.5
|
|
Pain (Visual Analogue Scale) and Change From Baseline at 1, 2, 3 &6 Months
3 months
|
2.5 scores on a scale
Standard Error 0.8
|
2.3 scores on a scale
Standard Error 0.6
|
|
Pain (Visual Analogue Scale) and Change From Baseline at 1, 2, 3 &6 Months
6 months
|
2.6 scores on a scale
Standard Error 0.7
|
3.4 scores on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: baseline, 1 month, 2 months, 3 months, 6 monthsIt consists of 24 items: five pertaining to pain perception, two to stiffness, and 17 to physical function. Individual scores were then summed to form a raw score ranging from 0 (best) to 2400 (worst). Finally, WOMAC total score normalized between 0 (best) and 100 (worst).
Outcome measures
| Measure |
PRP Group
n=11 Participants
single intra-articular injection of 2mL PRP (RegentKit-THT-1, RegenLab SA, Mont-sur-Lausanne, Switzerland)
Platelet-Rich Plasma Intra-Articular Injection
|
HA Group
n=11 Participants
five weekly intra-articular injections of 2.5 mL of hyaluronate sodium (ARTZDispo, Seikagaku Corporation Japan).
Hyaluronic Acid Viscosupplementation
|
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline at 1, 2, 3 &6 Months
Baseline
|
38.3 scores on a scale
Standard Error 3.4
|
33.4 scores on a scale
Standard Error 5.5
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline at 1, 2, 3 &6 Months
1 month
|
28.7 scores on a scale
Standard Error 3.7
|
19.1 scores on a scale
Standard Error 3.9
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline at 1, 2, 3 &6 Months
2 months
|
27.3 scores on a scale
Standard Error 3.3
|
21.3 scores on a scale
Standard Error 3.7
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline at 1, 2, 3 &6 Months
3 months
|
29.9 scores on a scale
Standard Error 3.9
|
27.1 scores on a scale
Standard Error 4.7
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline at 1, 2, 3 &6 Months
6 months
|
29.4 scores on a scale
Standard Error 3.7
|
35.8 scores on a scale
Standard Error 5.0
|
SECONDARY outcome
Timeframe: baseline, 1 month, 2 months, 3 months, 6 monthsThe SF-36 is a 36-item assessment tool that measures eight general health concepts including physical functioning, role limitation due to physical health problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health. Individual scores were then summed to form a total score ranging from 0 (worst) to 100 (best). Higher scores mean a better outcome.
Outcome measures
| Measure |
PRP Group
n=11 Participants
single intra-articular injection of 2mL PRP (RegentKit-THT-1, RegenLab SA, Mont-sur-Lausanne, Switzerland)
Platelet-Rich Plasma Intra-Articular Injection
|
HA Group
n=11 Participants
five weekly intra-articular injections of 2.5 mL of hyaluronate sodium (ARTZDispo, Seikagaku Corporation Japan).
Hyaluronic Acid Viscosupplementation
|
|---|---|---|
|
Short Form-36 (SF-36) From Baseline at 1, 2, 3 &6 Months
Baseline
|
56.7 scores on a scale
Standard Error 5.3
|
54.7 scores on a scale
Standard Error 4.9
|
|
Short Form-36 (SF-36) From Baseline at 1, 2, 3 &6 Months
1 month
|
62.8 scores on a scale
Standard Error 4.6
|
58.5 scores on a scale
Standard Error 5.0
|
|
Short Form-36 (SF-36) From Baseline at 1, 2, 3 &6 Months
2 months
|
63.5 scores on a scale
Standard Error 4.1
|
63.5 scores on a scale
Standard Error 3.6
|
|
Short Form-36 (SF-36) From Baseline at 1, 2, 3 &6 Months
3 months
|
61.7 scores on a scale
Standard Error 4.7
|
63.3 scores on a scale
Standard Error 3.1
|
|
Short Form-36 (SF-36) From Baseline at 1, 2, 3 &6 Months
6 months
|
65.1 scores on a scale
Standard Error 3.7
|
58.3 scores on a scale
Standard Error 4.7
|
SECONDARY outcome
Timeframe: baseline, 1 month, 2 months, 3 months, 6 monthsSynovial thickness (mm) by ultrasonography were evaluated from the lateral, middle, and medial aspects of the anterior suprapatellar recess
Outcome measures
| Measure |
PRP Group
n=11 Participants
single intra-articular injection of 2mL PRP (RegentKit-THT-1, RegenLab SA, Mont-sur-Lausanne, Switzerland)
Platelet-Rich Plasma Intra-Articular Injection
|
HA Group
n=11 Participants
five weekly intra-articular injections of 2.5 mL of hyaluronate sodium (ARTZDispo, Seikagaku Corporation Japan).
Hyaluronic Acid Viscosupplementation
|
|---|---|---|
|
Ultrasonographic Synovial Thickness (mm) and Change From Baseline at 1, 2, 3 &6 Months
Baseline
|
8.0 mm
Standard Error 1.3
|
6.9 mm
Standard Error 1.0
|
|
Ultrasonographic Synovial Thickness (mm) and Change From Baseline at 1, 2, 3 &6 Months
1 month
|
7.1 mm
Standard Error 1.0
|
6.5 mm
Standard Error 1.2
|
|
Ultrasonographic Synovial Thickness (mm) and Change From Baseline at 1, 2, 3 &6 Months
2 months
|
7.0 mm
Standard Error 1.3
|
6.1 mm
Standard Error 1.1
|
|
Ultrasonographic Synovial Thickness (mm) and Change From Baseline at 1, 2, 3 &6 Months
3 months
|
7.2 mm
Standard Error 1.2
|
6.0 mm
Standard Error 1.1
|
|
Ultrasonographic Synovial Thickness (mm) and Change From Baseline at 1, 2, 3 &6 Months
6 months
|
6.9 mm
Standard Error 1.0
|
6.0 mm
Standard Error 1.1
|
SECONDARY outcome
Timeframe: baseline, 1 month, 2 months, 3 months, 6 monthsPower Doppler assessment of the selected synovial sites was performed with settings standardized to a pulse repetition frequency of 700 Hz. The power Doppler gain was adjusted to a level just below the disappearance of artifacts under the bony cortex.14,15 The intensity of blood flow in the synovium was scored on a semiquantitative scale from 0-3 (grade 0, no intraarticular colour signal; grade 1, up to 3 color signals or 2 single and 1 confluent signal in the intraarticular area; grade 2, greater than grade 1 to \<50% of the intraarticular area filled with color signals; grade 3, ≥50% of the intraarticular area filled with color signals)
Outcome measures
| Measure |
PRP Group
n=11 Participants
single intra-articular injection of 2mL PRP (RegentKit-THT-1, RegenLab SA, Mont-sur-Lausanne, Switzerland)
Platelet-Rich Plasma Intra-Articular Injection
|
HA Group
n=11 Participants
five weekly intra-articular injections of 2.5 mL of hyaluronate sodium (ARTZDispo, Seikagaku Corporation Japan).
Hyaluronic Acid Viscosupplementation
|
|---|---|---|
|
Synovial Hyperemia (Score) and Change From Baseline at 1, 2, 3 &6 Months
Baseline
|
1.0 scores on a scale
Standard Error 0.3
|
0.9 scores on a scale
Standard Error 0.2
|
|
Synovial Hyperemia (Score) and Change From Baseline at 1, 2, 3 &6 Months
1 month
|
0.9 scores on a scale
Standard Error 0.3
|
0.4 scores on a scale
Standard Error 0.1
|
|
Synovial Hyperemia (Score) and Change From Baseline at 1, 2, 3 &6 Months
2 months
|
0.3 scores on a scale
Standard Error 0.2
|
0.2 scores on a scale
Standard Error 0.1
|
|
Synovial Hyperemia (Score) and Change From Baseline at 1, 2, 3 &6 Months
3 months
|
0.4 scores on a scale
Standard Error 0.2
|
0.3 scores on a scale
Standard Error 0.1
|
|
Synovial Hyperemia (Score) and Change From Baseline at 1, 2, 3 &6 Months
6 months
|
0.3 scores on a scale
Standard Error 0.1
|
0.3 scores on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: baseline, 1 month, 2 months, 3 months, 6 monthsOutcome measures
| Measure |
PRP Group
n=11 Participants
single intra-articular injection of 2mL PRP (RegentKit-THT-1, RegenLab SA, Mont-sur-Lausanne, Switzerland)
Platelet-Rich Plasma Intra-Articular Injection
|
HA Group
n=11 Participants
five weekly intra-articular injections of 2.5 mL of hyaluronate sodium (ARTZDispo, Seikagaku Corporation Japan).
Hyaluronic Acid Viscosupplementation
|
|---|---|---|
|
Range of Motion (ROM, Degrees) From Baseline at 1, 2, 3 &6 Months
3 months
|
101.4 degree
Standard Error 7.8
|
91.8 degree
Standard Error 8.1
|
|
Range of Motion (ROM, Degrees) From Baseline at 1, 2, 3 &6 Months
Baseline
|
92.3 degree
Standard Error 8.5
|
90.9 degree
Standard Error 8.3
|
|
Range of Motion (ROM, Degrees) From Baseline at 1, 2, 3 &6 Months
1 month
|
99.5 degree
Standard Error 7.6
|
91.8 degree
Standard Error 8.1
|
|
Range of Motion (ROM, Degrees) From Baseline at 1, 2, 3 &6 Months
2 months
|
102.3 degree
Standard Error 7.9
|
91.8 degree
Standard Error 8.1
|
|
Range of Motion (ROM, Degrees) From Baseline at 1, 2, 3 &6 Months
6 months
|
100.9 degree
Standard Error 8.5
|
91.8 degree
Standard Error 8.1
|
SECONDARY outcome
Timeframe: baseline, 1 month, 2 months, 3 months, 6 monthsEpisode(s) of hemarthrosis in the previous one month
Outcome measures
| Measure |
PRP Group
n=11 Participants
single intra-articular injection of 2mL PRP (RegentKit-THT-1, RegenLab SA, Mont-sur-Lausanne, Switzerland)
Platelet-Rich Plasma Intra-Articular Injection
|
HA Group
n=11 Participants
five weekly intra-articular injections of 2.5 mL of hyaluronate sodium (ARTZDispo, Seikagaku Corporation Japan).
Hyaluronic Acid Viscosupplementation
|
|---|---|---|
|
Hemarthrosis From Baseline at 1, 2, 3 &6 Months
Baseline
|
0.5 episode (s)
Standard Error 0.2
|
0.7 episode (s)
Standard Error 0.2
|
|
Hemarthrosis From Baseline at 1, 2, 3 &6 Months
1 month
|
0.4 episode (s)
Standard Error 0.2
|
0.4 episode (s)
Standard Error 0.1
|
|
Hemarthrosis From Baseline at 1, 2, 3 &6 Months
2 months
|
0 episode (s)
Standard Error 0
|
0.3 episode (s)
Standard Error 0.1
|
|
Hemarthrosis From Baseline at 1, 2, 3 &6 Months
3 months
|
0.6 episode (s)
Standard Error 0.3
|
0.3 episode (s)
Standard Error 0.2
|
|
Hemarthrosis From Baseline at 1, 2, 3 &6 Months
6 months
|
0.4 episode (s)
Standard Error 0.3
|
0.6 episode (s)
Standard Error 0.2
|
Adverse Events
PRP Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HA 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place