Trial Outcomes & Findings for Microfragmented Adipose Tissue Versus Platelet-rich Plasma for Knee Osteoarthritis: a Randomized Comparative Trial (NCT NCT04351087)
NCT ID: NCT04351087
Last Updated: 2024-08-09
Results Overview
The Knee injury and Osteoarthritis Outcome Pain Score \[KOOS questionnaire\] is a self-reported outcome measure assessing the patient's opinion about the pain in their knee. Standardized answer options are given \[5 Likert boxes\] and each question is assigned a score from 0 to 4. A normalized score \[100 indicating no pain and 0 indicating extreme pain\] is calculated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
79 participants
Primary outcome timeframe
6 months
Results posted on
2024-08-09
Participant Flow
8 participants were excluded prior to intervention due to not meeting inclusion criteria.
Participant milestones
| Measure |
Platelet Rich Plasma
157cc of whole blood will be harvested via standard venipuncture from the antecubital fossa and mixed with 24cc ACD-A (manufacturer recommends 8cc ACD-A per 52cc of whole blood). 156ml of whole blood will be processed in the FDA Cleared Angel cPRP system at 2% hematocrit. 1ml of whole blood and the resultant PRP will be analyzed in the Sysmex XN-350 for complete analysis (platelet, leukocyte, red blood cell counts). The remaining PRP will be injected under sterile technique using ultrasound-guidance through a superolateral approach. For patient comfort, 2cc of 1% lidocaine can be administered using a 26-gauge needle (into soft tissues only). PRP will then be injected using a 25-guage needle. A maximum of 6ml of PRP will be injected. Injection site will be cleaned and bandaged and patient will be dismissed with post-injection precautions and 1 month follow-up scheduled.
Platelet Rich Plasma: Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
|
Microfragmented Adipose Tissue
Adipose is aspirated from the subcutaneous tissue of the buttock or abdomen. Aspiration site is injected with 10ml 1% lidocaine with epinephrine. A small poke incision is made with an 11-blade scalpel. Then 120ml of Klein solution is injected into the adipose tissue. Solution sits for 15 minutes to allow for adequate anesthesia. Aspiration cannula is inserted and moved in a back and forth motion for 2 minutes to allow for adipose aspiration. 30ml fat will be aspirated. Aspiration site is cleaned and bandaged. The aspirated fat is processed using the Lipogems system. 30ml of adipose is transferred to the device, saline is run through the device to remove oils and then approximately 5-7ml of adipose tissue is removed and ready for injection. The Microfragmented adipose tissue are then injected in identical fashion to the PRP above.
Platelet Rich Plasma: Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
35
|
|
Overall Study
COMPLETED
|
23
|
26
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
Reasons for withdrawal
| Measure |
Platelet Rich Plasma
157cc of whole blood will be harvested via standard venipuncture from the antecubital fossa and mixed with 24cc ACD-A (manufacturer recommends 8cc ACD-A per 52cc of whole blood). 156ml of whole blood will be processed in the FDA Cleared Angel cPRP system at 2% hematocrit. 1ml of whole blood and the resultant PRP will be analyzed in the Sysmex XN-350 for complete analysis (platelet, leukocyte, red blood cell counts). The remaining PRP will be injected under sterile technique using ultrasound-guidance through a superolateral approach. For patient comfort, 2cc of 1% lidocaine can be administered using a 26-gauge needle (into soft tissues only). PRP will then be injected using a 25-guage needle. A maximum of 6ml of PRP will be injected. Injection site will be cleaned and bandaged and patient will be dismissed with post-injection precautions and 1 month follow-up scheduled.
Platelet Rich Plasma: Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
|
Microfragmented Adipose Tissue
Adipose is aspirated from the subcutaneous tissue of the buttock or abdomen. Aspiration site is injected with 10ml 1% lidocaine with epinephrine. A small poke incision is made with an 11-blade scalpel. Then 120ml of Klein solution is injected into the adipose tissue. Solution sits for 15 minutes to allow for adequate anesthesia. Aspiration cannula is inserted and moved in a back and forth motion for 2 minutes to allow for adipose aspiration. 30ml fat will be aspirated. Aspiration site is cleaned and bandaged. The aspirated fat is processed using the Lipogems system. 30ml of adipose is transferred to the device, saline is run through the device to remove oils and then approximately 5-7ml of adipose tissue is removed and ready for injection. The Microfragmented adipose tissue are then injected in identical fashion to the PRP above.
Platelet Rich Plasma: Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Lack of Efficacy
|
3
|
2
|
Baseline Characteristics
Demographics were analyzed on the cohort that completed enrollment.
Baseline characteristics by cohort
| Measure |
Platelet Rich Plasma
n=23 Participants
157cc of whole blood will be harvested via standard venipuncture from the antecubital fossa and mixed with 24cc ACD-A (manufacturer recommends 8cc ACD-A per 52cc of whole blood). 156ml of whole blood will be processed in the FDA Cleared Angel cPRP system at 2% hematocrit. 1ml of whole blood and the resultant PRP will be analyzed in the Sysmex XN-350 for complete analysis (platelet, leukocyte, red blood cell counts). The remaining PRP will be injected under sterile technique using ultrasound-guidance through a superolateral approach. For patient comfort, 2cc of 1% lidocaine can be administered using a 26-gauge needle (into soft tissues only). PRP will then be injected using a 25-guage needle. A maximum of 6ml of PRP will be injected. Injection site will be cleaned and bandaged and patient will be dismissed with post-injection precautions and 1 month follow-up scheduled.
Platelet Rich Plasma: Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
|
Microfragmented Adipose Tissue
n=26 Participants
Adipose is aspirated from the subcutaneous tissue of the buttock or abdomen. Aspiration site is injected with 10ml 1% lidocaine with epinephrine. A small poke incision is made with an 11-blade scalpel. Then 120ml of Klein solution is injected into the adipose tissue. Solution sits for 15 minutes to allow for adequate anesthesia. Aspiration cannula is inserted and moved in a back and forth motion for 2 minutes to allow for adipose aspiration. 30ml fat will be aspirated. Aspiration site is cleaned and bandaged. The aspirated fat is processed using the Lipogems system. 30ml of adipose is transferred to the device, saline is run through the device to remove oils and then approximately 5-7ml of adipose tissue is removed and ready for injection. The Microfragmented adipose tissue are then injected in identical fashion to the PRP above.
Platelet Rich Plasma: Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 14.0 • n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
56.7 years
STANDARD_DEVIATION 7.8 • n=7 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
56.3 years
STANDARD_DEVIATION 8.9 • n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
18 Participants
n=7 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
25 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
8 Participants
n=7 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
24 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
0 Participants
n=7 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
0 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
1 Participants
n=7 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
3 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
0 Participants
n=7 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
0 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
3 Participants
n=7 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
7 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
22 Participants
n=7 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
39 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
0 Participants
n=7 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
0 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
0 Participants
n=7 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
0 Participants
n=5 Participants • Demographics were analyzed on the cohort that completed enrollment.
|
|
Knee Injury and Osteoarthritis Outcome Pain Score [KOOS Pain]
|
51.7 units on a scale
STANDARD_DEVIATION 10.8 • n=5 Participants • Measure Analysis Population Description: Demographics were analyzed on the cohort that completed enrollment.
|
51.1 units on a scale
STANDARD_DEVIATION 10.2 • n=7 Participants • Measure Analysis Population Description: Demographics were analyzed on the cohort that completed enrollment.
|
51.4 units on a scale
STANDARD_DEVIATION 10.3 • n=5 Participants • Measure Analysis Population Description: Demographics were analyzed on the cohort that completed enrollment.
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Out of 36 subjects randomized to receive platelet rich plasma, 33 received allocated intervention and 3 voluntarily withdrew prior to intervention. Out of the 33, 7 were lost to follow up and 3 discontinued intervention. Out of 35 subjects randomized to receive microfragmented adipose tissue, 31 received allocated intervention and 4 voluntarily withdrew prior to intervention. Out of the 31, 3 were lost to follow up and 2 discontinued intervention.
The Knee injury and Osteoarthritis Outcome Pain Score \[KOOS questionnaire\] is a self-reported outcome measure assessing the patient's opinion about the pain in their knee. Standardized answer options are given \[5 Likert boxes\] and each question is assigned a score from 0 to 4. A normalized score \[100 indicating no pain and 0 indicating extreme pain\] is calculated.
Outcome measures
| Measure |
Platelet Rich Plasma
n=23 Participants
157cc of whole blood will be harvested via standard venipuncture from the antecubital fossa and mixed with 24cc ACD-A (manufacturer recommends 8cc ACD-A per 52cc of whole blood). 156ml of whole blood will be processed in the FDA Cleared Angel cPRP system at 2% hematocrit. 1ml of whole blood and the resultant PRP will be analyzed in the Sysmex XN-350 for complete analysis (platelet, leukocyte, red blood cell counts). The remaining PRP will be injected under sterile technique using ultrasound-guidance through a superolateral approach. For patient comfort, 2cc of 1% lidocaine can be administered using a 26-gauge needle (into soft tissues only). PRP will then be injected using a 25-guage needle. A maximum of 6ml of PRP will be injected. Injection site will be cleaned and bandaged and patient will be dismissed with post-injection precautions and 1 month follow-up scheduled.
Platelet Rich Plasma: Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
|
Microfragmented Adipose Tissue
n=26 Participants
Adipose is aspirated from the subcutaneous tissue of the buttock or abdomen. Aspiration site is injected with 10ml 1% lidocaine with epinephrine. A small poke incision is made with an 11-blade scalpel. Then 120ml of Klein solution is injected into the adipose tissue. Solution sits for 15 minutes to allow for adequate anesthesia. Aspiration cannula is inserted and moved in a back and forth motion for 2 minutes to allow for adipose aspiration. 30ml fat will be aspirated. Aspiration site is cleaned and bandaged. The aspirated fat is processed using the Lipogems system. 30ml of adipose is transferred to the device, saline is run through the device to remove oils and then approximately 5-7ml of adipose tissue is removed and ready for injection. The Microfragmented adipose tissue are then injected in identical fashion to the PRP above.
Platelet Rich Plasma: Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
|
|---|---|---|
|
KOOS Pain [Knee Injury and Osteoarthritis Outcome Score]
|
79.95 units on a scale
Standard Deviation 17.86
|
77.78 units on a scale
Standard Deviation 19.33
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Out of 36 subjects randomized to receive platelet rich plasma, 33 received allocated intervention and 3 voluntarily withdrew prior to intervention. Out of the 33, 7 were lost to follow up and 3 discontinued intervention. Out of 35 subjects randomized to receive microfragmented adipose tissue, 31 received allocated intervention and 4 voluntarily withdrew prior to intervention. Out of the 31, 3 were lost to follow up and 2 discontinued intervention.
The visual analog pain scale \[VAS\] is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 \[no pain\] and 10 \[worst pain\].
Outcome measures
| Measure |
Platelet Rich Plasma
n=23 Participants
157cc of whole blood will be harvested via standard venipuncture from the antecubital fossa and mixed with 24cc ACD-A (manufacturer recommends 8cc ACD-A per 52cc of whole blood). 156ml of whole blood will be processed in the FDA Cleared Angel cPRP system at 2% hematocrit. 1ml of whole blood and the resultant PRP will be analyzed in the Sysmex XN-350 for complete analysis (platelet, leukocyte, red blood cell counts). The remaining PRP will be injected under sterile technique using ultrasound-guidance through a superolateral approach. For patient comfort, 2cc of 1% lidocaine can be administered using a 26-gauge needle (into soft tissues only). PRP will then be injected using a 25-guage needle. A maximum of 6ml of PRP will be injected. Injection site will be cleaned and bandaged and patient will be dismissed with post-injection precautions and 1 month follow-up scheduled.
Platelet Rich Plasma: Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
|
Microfragmented Adipose Tissue
n=26 Participants
Adipose is aspirated from the subcutaneous tissue of the buttock or abdomen. Aspiration site is injected with 10ml 1% lidocaine with epinephrine. A small poke incision is made with an 11-blade scalpel. Then 120ml of Klein solution is injected into the adipose tissue. Solution sits for 15 minutes to allow for adequate anesthesia. Aspiration cannula is inserted and moved in a back and forth motion for 2 minutes to allow for adipose aspiration. 30ml fat will be aspirated. Aspiration site is cleaned and bandaged. The aspirated fat is processed using the Lipogems system. 30ml of adipose is transferred to the device, saline is run through the device to remove oils and then approximately 5-7ml of adipose tissue is removed and ready for injection. The Microfragmented adipose tissue are then injected in identical fashion to the PRP above.
Platelet Rich Plasma: Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
|
|---|---|---|
|
VAS [Visual Analog Pain Scale] Pain Score
|
1.6 units on a scale
Standard Deviation 0.4
|
1.4 units on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Out of 36 subjects randomized to receive platelet rich plasma, 33 received allocated intervention and 3 voluntarily withdrew prior to intervention. Out of the 33, 7 were lost to follow up and 3 discontinued intervention. Out of 35 subjects randomized to receive microfragmented adipose tissue, 31 received allocated intervention and 4 voluntarily withdrew prior to intervention. Out of the 31, 3 were lost to follow up and 2 discontinued intervention.
The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
Outcome measures
| Measure |
Platelet Rich Plasma
n=23 Participants
157cc of whole blood will be harvested via standard venipuncture from the antecubital fossa and mixed with 24cc ACD-A (manufacturer recommends 8cc ACD-A per 52cc of whole blood). 156ml of whole blood will be processed in the FDA Cleared Angel cPRP system at 2% hematocrit. 1ml of whole blood and the resultant PRP will be analyzed in the Sysmex XN-350 for complete analysis (platelet, leukocyte, red blood cell counts). The remaining PRP will be injected under sterile technique using ultrasound-guidance through a superolateral approach. For patient comfort, 2cc of 1% lidocaine can be administered using a 26-gauge needle (into soft tissues only). PRP will then be injected using a 25-guage needle. A maximum of 6ml of PRP will be injected. Injection site will be cleaned and bandaged and patient will be dismissed with post-injection precautions and 1 month follow-up scheduled.
Platelet Rich Plasma: Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
|
Microfragmented Adipose Tissue
n=26 Participants
Adipose is aspirated from the subcutaneous tissue of the buttock or abdomen. Aspiration site is injected with 10ml 1% lidocaine with epinephrine. A small poke incision is made with an 11-blade scalpel. Then 120ml of Klein solution is injected into the adipose tissue. Solution sits for 15 minutes to allow for adequate anesthesia. Aspiration cannula is inserted and moved in a back and forth motion for 2 minutes to allow for adipose aspiration. 30ml fat will be aspirated. Aspiration site is cleaned and bandaged. The aspirated fat is processed using the Lipogems system. 30ml of adipose is transferred to the device, saline is run through the device to remove oils and then approximately 5-7ml of adipose tissue is removed and ready for injection. The Microfragmented adipose tissue are then injected in identical fashion to the PRP above.
Platelet Rich Plasma: Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
|
|---|---|---|
|
Tegner Activity Scale
|
3.9 score on a scale
Standard Deviation 0.3
|
4.3 score on a scale
Standard Deviation 0.3
|
Adverse Events
Platelet Rich Plasma
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Microfragmented Adipose Tissue
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Platelet Rich Plasma
n=36 participants at risk
157cc of whole blood will be harvested via standard venipuncture from the antecubital fossa and mixed with 24cc ACD-A (manufacturer recommends 8cc ACD-A per 52cc of whole blood). 156ml of whole blood will be processed in the FDA Cleared Angel cPRP system at 2% hematocrit. 1ml of whole blood and the resultant PRP will be analyzed in the Sysmex XN-350 for complete analysis (platelet, leukocyte, red blood cell counts). The remaining PRP will be injected under sterile technique using ultrasound-guidance through a superolateral approach. For patient comfort, 2cc of 1% lidocaine can be administered using a 26-gauge needle (into soft tissues only). PRP will then be injected using a 25-guage needle. A maximum of 6ml of PRP will be injected. Injection site will be cleaned and bandaged and patient will be dismissed with post-injection precautions and 1 month follow-up scheduled.
Platelet Rich Plasma: Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
|
Microfragmented Adipose Tissue
n=35 participants at risk
Adipose is aspirated from the subcutaneous tissue of the buttock or abdomen. Aspiration site is injected with 10ml 1% lidocaine with epinephrine. A small poke incision is made with an 11-blade scalpel. Then 120ml of Klein solution is injected into the adipose tissue. Solution sits for 15 minutes to allow for adequate anesthesia. Aspiration cannula is inserted and moved in a back and forth motion for 2 minutes to allow for adipose aspiration. 30ml fat will be aspirated. Aspiration site is cleaned and bandaged. The aspirated fat is processed using the Lipogems system. 30ml of adipose is transferred to the device, saline is run through the device to remove oils and then approximately 5-7ml of adipose tissue is removed and ready for injection. The Microfragmented adipose tissue are then injected in identical fashion to the PRP above.
Platelet Rich Plasma: Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Swelling
|
11.1%
4/36 • Number of events 4 • Adverse event data was collected from baseline through 1 year post injection.
|
2.9%
1/35 • Number of events 1 • Adverse event data was collected from baseline through 1 year post injection.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
19.4%
7/36 • Number of events 8 • Adverse event data was collected from baseline through 1 year post injection.
|
20.0%
7/35 • Number of events 7 • Adverse event data was collected from baseline through 1 year post injection.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place