Trial Outcomes & Findings for PRP vs Corticosteroid in Baker's Cyst (NCT NCT02249377)
NCT ID: NCT02249377
Last Updated: 2020-03-18
Results Overview
Outcome measure will be determined through the use of the Visual Analogue Score (VAS) and the Rauschning and Lindgren criteria which are used to clinically evaluate the presence of the popliteal cysts, pain, posterior sense of tension in the popliteal fossa and its clinical importance for range of motion reduction. The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess short and long term outcome of knee related conditions.
TERMINATED
PHASE3
50 participants
6 Months
2020-03-18
Participant Flow
Participant milestones
| Measure |
Platelets-Rich-Plasma Group
Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.
Platelets-Rich-Plasma: Platelet-Rich Plasma
|
Corticosteroid Group:
Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.
Corticosteroid: Corticosteroid
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
25
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Platelets-Rich-Plasma Group
Patients will be asked to stop taking any type of anti-inflammatory medication from 7 days before the procedure to 2 weeks after and fasting for 3 hours before the procedure. At the moment of the procedure, the radiology team will draw 60ml of venous blood from the patient, the blood will be processed with different components of the PRP kit and centrifuged in the SmartPrep PRP machine, to obtain the PRP. The patient is then scanned prone using a linear 14 or 9 megahertz (MHz) transducer. A 20 Gauge spinal needle is usually employed for purposes of aspiration. Sterile saline will be used to confirm needle placement in the cyst in lieu of lidocaine and then inject the PRP by the radiologist.
Platelets-Rich-Plasma: Platelet-Rich Plasma
|
Corticosteroid Group:
n=1 Participants
Patients will be asked to stop taking any kind of anti-inflammatory medication from 7 days before the procedure to 2 weeks after but fasting in this group won't be required. An ultrasound guided aspiration and triamcinolone (40 mg) diluted with lidocaine without epinephrine and ropivacaine will be used to anesthetize the tissues down to the cyst (including within the cyst for steroid injections). A compression bandage will be placed locally for 7 days. Investigators will monitor any side effect from the injection and treat the patients per standard care - this can include prescription of analgesics.
Corticosteroid: Corticosteroid
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.
Outcome measure will be determined through the use of the Visual Analogue Score (VAS) and the Rauschning and Lindgren criteria which are used to clinically evaluate the presence of the popliteal cysts, pain, posterior sense of tension in the popliteal fossa and its clinical importance for range of motion reduction. The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess short and long term outcome of knee related conditions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 MonthsPopulation: The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.
Outcome measure will be determined through the use of the Visual Analogue Score (VAS) and the Rauschning and Lindgren criteria which are used to clinically evaluate the presence of the popliteal cysts, pain, posterior sense of tension in the popliteal fossa and its clinical importance for range of motion reduction. The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess short and long term outcome of knee related conditions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 MonthsPopulation: The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.
All disease signs and symptoms experienced by the patient, as defined as an Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Unexpected Adverse Device Effect (UADE), will be recorded from questionnaires during each study visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 MonthsPopulation: The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.
All disease signs and symptoms experienced by the patient, as defined as an Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Unexpected Adverse Device Effect (UADE), will be recorded from questionnaires during each study visit.
Outcome measures
Outcome data not reported
Adverse Events
Platelets-Rich-Plasma Group
Corticosteroid Group:
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