Trial Outcomes & Findings for Intra Articular Injections With Platelet Rich Plasma in Patients With Juvenile Osteochondritis Dissecans of the Knee (NCT NCT02397278)
NCT ID: NCT02397278
Last Updated: 2021-08-05
Results Overview
Measured by dGEMRIC MRI
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
6 months
Results posted on
2021-08-05
Participant Flow
Participant milestones
| Measure |
Platelet Rich Plasma (PRP)
Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
Platelet rich plasma (PRP): Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy.
|
Conventional Therapy
Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Platelet Rich Plasma (PRP)
Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
Platelet rich plasma (PRP): Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy.
|
Conventional Therapy
Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Deemed ineligible following surgery
|
1
|
1
|
Baseline Characteristics
Intra Articular Injections With Platelet Rich Plasma in Patients With Juvenile Osteochondritis Dissecans of the Knee
Baseline characteristics by cohort
| Measure |
Platelet Rich Plasma (PRP)
n=7 Participants
Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
Platelet rich plasma (PRP): Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy.
|
Conventional Therapy
n=8 Participants
Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
12 years
n=99 Participants
|
11.335 years
n=107 Participants
|
11.6 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This outcome measure for post-contrast dGEMRIC studies was not collected. The protocol was amended to include non-contrast studies due to difficulty recruiting patients.
Measured by dGEMRIC MRI
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Not all participants were available for analysis.
Measured by the Pediatric IKDC survey results. The International Knee Documentation Committee questionnaire measures knee function, Scores range from 1-100, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Platelet Rich Plasma (PRP)
n=8 Participants
Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
Platelet rich plasma (PRP): Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy.
|
Conventional Therapy
n=5 Participants
Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
|
|---|---|---|
|
Improvement in Pain, Performance and Overall Function: IKDC
Month 6
|
86 score on a scale
Standard Deviation 21
|
84 score on a scale
Standard Deviation 20
|
|
Improvement in Pain, Performance and Overall Function: IKDC
Baseline
|
48 score on a scale
Standard Deviation 21
|
52 score on a scale
Standard Deviation 34
|
|
Improvement in Pain, Performance and Overall Function: IKDC
Month 12
|
84 score on a scale
Standard Deviation 18
|
90 score on a scale
Standard Deviation 9
|
SECONDARY outcome
Timeframe: BaselinePopulation: Not all participants were available for analysis.
Measured by the KOOS survey results. The Knee injury and Osteoarthritis Outcome Score (KOOS) measures patient reported knee function and quality of life. Possible scores range from 0 to 100, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Platelet Rich Plasma (PRP)
n=8 Participants
Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
Platelet rich plasma (PRP): Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy.
|
Conventional Therapy
n=5 Participants
Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
|
|---|---|---|
|
Improvement in Pain, Performance and Overall Function: KOOS, Baseline
Sport Subscale
|
23.8 score on a scale
Standard Deviation 21.1
|
30.7 score on a scale
Standard Deviation 42.2
|
|
Improvement in Pain, Performance and Overall Function: KOOS, Baseline
Quality of Life Subscale
|
43.1 score on a scale
Standard Deviation 19.9
|
28.3 score on a scale
Standard Deviation 20.3
|
|
Improvement in Pain, Performance and Overall Function: KOOS, Baseline
Pain Subscale
|
56.8 score on a scale
Standard Deviation 21.6
|
50.0 score on a scale
Standard Deviation 24.6
|
|
Improvement in Pain, Performance and Overall Function: KOOS, Baseline
Symptoms Subscale
|
67.3 score on a scale
Standard Deviation 24.7
|
65.0 score on a scale
Standard Deviation 17.0
|
|
Improvement in Pain, Performance and Overall Function: KOOS, Baseline
Activities of Daily Living Subscale
|
70.1 score on a scale
Standard Deviation 24.5
|
60.7 score on a scale
Standard Deviation 25.2
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Not all participants were available for analysis.
Measured by the KOOS survey results. The Knee injury and Osteoarthritis Outcome Score (KOOS) measures patient reported knee function and quality of life. Possible scores range from 0 to 100, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Platelet Rich Plasma (PRP)
n=6 Participants
Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
Platelet rich plasma (PRP): Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy.
|
Conventional Therapy
n=4 Participants
Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
|
|---|---|---|
|
Improvement in Pain, Performance and Overall Function: KOOS, 6 Months
Pain Subscale
|
90.6 score on a scale
Standard Deviation 15.6
|
91.4 score on a scale
Standard Deviation 10.6
|
|
Improvement in Pain, Performance and Overall Function: KOOS, 6 Months
Activities of Daily Living Subscale
|
95.8 score on a scale
Standard Deviation 10.2
|
96.6 score on a scale
Standard Deviation 3.9
|
|
Improvement in Pain, Performance and Overall Function: KOOS, 6 Months
Quality of Life Subscale
|
68.1 score on a scale
Standard Deviation 22.6
|
53.1 score on a scale
Standard Deviation 32.5
|
|
Improvement in Pain, Performance and Overall Function: KOOS, 6 Months
Symptoms Subscale
|
84.6 score on a scale
Standard Deviation 5.4
|
89.3 score on a scale
Standard Deviation 12.3
|
|
Improvement in Pain, Performance and Overall Function: KOOS, 6 Months
Sport Subscale
|
88.1 score on a scale
Standard Deviation 29.2
|
69.6 score on a scale
Standard Deviation 40.6
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Not all participants were available for analysis.
Measured by the KOOS survey results. The Knee injury and Osteoarthritis Outcome Score (KOOS) measures patient reported knee function and quality of life. Possible scores range from 0 to 100, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Platelet Rich Plasma (PRP)
n=8 Participants
Patients will receive three PRP injections into the symptomatic knee; they will also be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
Platelet rich plasma (PRP): Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy.
|
Conventional Therapy
n=4 Participants
Patients will be fitted with a hinged brace locked in extension, with weight bearing as tolerated and crutches for those with pain upon weight bear, complete rest from impact activities with progression to weight bearing as tolerated for 6 weeks, and then followed according to the Sports Medicine department's protocol for OCD.
|
|---|---|---|
|
Improvement in Pain, Performance and Overall Function: KOOS, 12 Months
Pain Subscale
|
85.9 score on a scale
Standard Deviation 16.4
|
93.8 score on a scale
Standard Deviation 8.3
|
|
Improvement in Pain, Performance and Overall Function: KOOS, 12 Months
Sport Subscale
|
75.6 score on a scale
Standard Deviation 30.8
|
91.7 score on a scale
Standard Deviation 14.4
|
|
Improvement in Pain, Performance and Overall Function: KOOS, 12 Months
Symptoms Subscale
|
92.9 score on a scale
Standard Deviation 5.0
|
94.0 score on a scale
Standard Deviation 10.3
|
|
Improvement in Pain, Performance and Overall Function: KOOS, 12 Months
Activities of Daily Living Subscale
|
90.5 score on a scale
Standard Deviation 13.1
|
99.2 score on a scale
Standard Deviation 1.3
|
|
Improvement in Pain, Performance and Overall Function: KOOS, 12 Months
Quality of Life Subscale
|
56.9 score on a scale
Standard Deviation 24.2
|
75.0 score on a scale
Standard Deviation 14.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsMeasured by the results of the dGEMRIC MRI and the IKDC and KOOS survey results
Outcome measures
Outcome data not reported
Adverse Events
Platelet Rich Plasma (PRP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Therapy
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