Trial Outcomes & Findings for Efficacy of Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis. (NCT NCT03379168)
NCT ID: NCT03379168
Last Updated: 2025-02-13
Results Overview
Scaled pain score to assess change in a patient's knee pain over time. Pain level is marked on a 100 mm line with the 0 mm corresponding to "no pain" and the 100 mm corresponding to 10/10 pain. Using a ruler, the score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
Prior to procedure then post-procedure at 2 weeks
Results posted on
2025-02-13
Participant Flow
Participant milestones
| Measure |
Placebo Injection
Patients who are randomized to the placebo group will receive an injection of 7cc of sterile saline in the affected knee.
Saline: Sterile saline injection will act as a placebo group.
|
Corticosteroid Injection
Patients who are randomized to the corticosteroid group will receive an injection of 2cc (80mg) of triamcinalone acetonide injectable suspension mixed with 5 cc of 1% plain lidocaine for a total of 7cc of fluid injected in the affected knee.
Corticosteroid injection: Cortisone is a standard of care injection to reduce joint inflammation.
|
Lipogems Injection
Patients who are randomized to the Lipogems treatment group will undergo a lipoaspiration from their abdomen and autologous injection of the harvested adipocytes into their knee. It is standard to harvest three to four times more adipose tissue than is planned to be injected to account for tissue processing by the Lipogems device. The investigators plan to inject 7cc of autologous adipose tissue. Thus, the investigators will harvest between 25 and 30 cc of adipose tissue from each patient. The tissue will be processed immediately and 7cc will be injected. Any remaining adipose tissue will be disposed of immediately in biohazardous waste.
Microfragmented Adipose Tissue (Lipogems): Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. Lipoaspirate is harvested most commonly from the abdomen and washed in saline solution, then processed through a closed-system device that micro-fragments the adipose tissue. This mechanical process retains the vascular architecture, mature pericytes, and MSCs for autologous injection. Lipogems is currently FDA-approved for orthopedic and arthroscopic procedures; thus, this would be an on-label use for knee injections.
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
23
|
|
Overall Study
COMPLETED
|
18
|
16
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo Injection
n=22 Participants
Patients who are randomized to the placebo group will receive an injection of 7cc of sterile saline in the affected knee.
Saline: Sterile saline injection will act as a placebo group.
|
Corticosteroid Injection
n=23 Participants
Patients who are randomized to the corticosteroid group will receive an injection of 2cc (80mg) of triamcinalone acetonide injectable suspension mixed with 5 cc of 1% plain lidocaine for a total of 7cc of fluid injected in the affected knee.
Corticosteroid injection: Cortisone is a standard of care injection to reduce joint inflammation.
|
Lipogems Injection
n=23 Participants
Patients who are randomized to the Lipogems treatment group will undergo a lipoaspiration from their abdomen and autologous injection of the harvested adipocytes into their knee. It is standard to harvest three to four times more adipose tissue than is planned to be injected to account for tissue processing by the Lipogems device. The investigators plan to inject 7cc of autologous adipose tissue. Thus, the investigators will harvest between 25 and 30 cc of adipose tissue from each patient. The tissue will be processed immediately and 7cc will be injected. Any remaining adipose tissue will be disposed of immediately in biohazardous waste.
Microfragmented Adipose Tissue (Lipogems): Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. Lipoaspirate is harvested most commonly from the abdomen and washed in saline solution, then processed through a closed-system device that micro-fragments the adipose tissue. This mechanical process retains the vascular architecture, mature pericytes, and MSCs for autologous injection. Lipogems is currently FDA-approved for orthopedic and arthroscopic procedures; thus, this would be an on-label use for knee injections.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 10.8 • n=22 Participants
|
56.3 years
STANDARD_DEVIATION 11.5 • n=23 Participants
|
62.6 years
STANDARD_DEVIATION 8.4 • n=23 Participants
|
60.0 years
STANDARD_DEVIATION 10.5 • n=68 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=22 Participants
|
14 Participants
n=23 Participants
|
8 Participants
n=23 Participants
|
37 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=22 Participants
|
9 Participants
n=23 Participants
|
15 Participants
n=23 Participants
|
31 Participants
n=68 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Prior to procedure then post-procedure at 2 weeksScaled pain score to assess change in a patient's knee pain over time. Pain level is marked on a 100 mm line with the 0 mm corresponding to "no pain" and the 100 mm corresponding to 10/10 pain. Using a ruler, the score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Outcome measures
| Measure |
Placebo Injection
n=22 Participants
Patients who are randomized to the placebo group will receive an injection of 7cc of sterile saline in the affected knee.
Saline: Sterile saline injection will act as a placebo group.
|
Corticosteroid Injection
n=23 Participants
Patients who are randomized to the corticosteroid group will receive an injection of 2cc (80mg) of triamcinalone acetonide injectable suspension mixed with 5 cc of 1% plain lidocaine for a total of 7cc of fluid injected in the affected knee.
Corticosteroid injection: Cortisone is a standard of care injection to reduce joint inflammation.
|
Lipogems Injection
n=23 Participants
Patients who are randomized to the Lipogems treatment group will undergo a lipoaspiration from their abdomen and autologous injection of the harvested adipocytes into their knee. It is standard to harvest three to four times more adipose tissue than is planned to be injected to account for tissue processing by the Lipogems device. The investigators plan to inject 7cc of autologous adipose tissue. Thus, the investigators will harvest between 25 and 30 cc of adipose tissue from each patient. The tissue will be processed immediately and 7cc will be injected. Any remaining adipose tissue will be disposed of immediately in biohazardous waste.
Microfragmented Adipose Tissue (Lipogems): Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. Lipoaspirate is harvested most commonly from the abdomen and washed in saline solution, then processed through a closed-system device that micro-fragments the adipose tissue. This mechanical process retains the vascular architecture, mature pericytes, and MSCs for autologous injection. Lipogems is currently FDA-approved for orthopedic and arthroscopic procedures; thus, this would be an on-label use for knee injections.
|
|---|---|---|---|
|
Change in Visual Analog Pain Scale (VAS) Over Time
|
1.5 Median improvement in VAS pain score
Interval 0.0 to 2.5
|
2.0 Median improvement in VAS pain score
Interval 0.0 to 5.0
|
3.0 Median improvement in VAS pain score
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Prior to procedure then post-procedure at 2 weeksPatient self-reported outcome measure to assess pain, stiffness, and physical function in patients with knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), and Physical Function (17 items). The median is being reported for the three groups representing the change in the pain subscale. The following descriptors are used for all items: none, mild, moderate, severe, and extreme. These correspond to an ordinal scale of 0-4. The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A total WOMAC score is created by summing the items for all three subscales. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. The score can range from 0 to 96; however, this score is typically reported as a percentage of 100 for normalization.
Outcome measures
| Measure |
Placebo Injection
n=22 Participants
Patients who are randomized to the placebo group will receive an injection of 7cc of sterile saline in the affected knee.
Saline: Sterile saline injection will act as a placebo group.
|
Corticosteroid Injection
n=23 Participants
Patients who are randomized to the corticosteroid group will receive an injection of 2cc (80mg) of triamcinalone acetonide injectable suspension mixed with 5 cc of 1% plain lidocaine for a total of 7cc of fluid injected in the affected knee.
Corticosteroid injection: Cortisone is a standard of care injection to reduce joint inflammation.
|
Lipogems Injection
n=23 Participants
Patients who are randomized to the Lipogems treatment group will undergo a lipoaspiration from their abdomen and autologous injection of the harvested adipocytes into their knee. It is standard to harvest three to four times more adipose tissue than is planned to be injected to account for tissue processing by the Lipogems device. The investigators plan to inject 7cc of autologous adipose tissue. Thus, the investigators will harvest between 25 and 30 cc of adipose tissue from each patient. The tissue will be processed immediately and 7cc will be injected. Any remaining adipose tissue will be disposed of immediately in biohazardous waste.
Microfragmented Adipose Tissue (Lipogems): Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. Lipoaspirate is harvested most commonly from the abdomen and washed in saline solution, then processed through a closed-system device that micro-fragments the adipose tissue. This mechanical process retains the vascular architecture, mature pericytes, and MSCs for autologous injection. Lipogems is currently FDA-approved for orthopedic and arthroscopic procedures; thus, this would be an on-label use for knee injections.
|
|---|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Over Time
|
3.5 scores on a scale
Interval 1.5 to 4.5
|
3.50 scores on a scale
Interval 0.0 to 6.5
|
5.00 scores on a scale
Interval 3.5 to 7.0
|
SECONDARY outcome
Timeframe: Prior to procedure then post-procedure at 2 weeksPatient self-reported outcome measure to assess the patient's opinion about their knee and associated issues. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated by adding the subscales together.
Outcome measures
| Measure |
Placebo Injection
n=22 Participants
Patients who are randomized to the placebo group will receive an injection of 7cc of sterile saline in the affected knee.
Saline: Sterile saline injection will act as a placebo group.
|
Corticosteroid Injection
n=23 Participants
Patients who are randomized to the corticosteroid group will receive an injection of 2cc (80mg) of triamcinalone acetonide injectable suspension mixed with 5 cc of 1% plain lidocaine for a total of 7cc of fluid injected in the affected knee.
Corticosteroid injection: Cortisone is a standard of care injection to reduce joint inflammation.
|
Lipogems Injection
n=23 Participants
Patients who are randomized to the Lipogems treatment group will undergo a lipoaspiration from their abdomen and autologous injection of the harvested adipocytes into their knee. It is standard to harvest three to four times more adipose tissue than is planned to be injected to account for tissue processing by the Lipogems device. The investigators plan to inject 7cc of autologous adipose tissue. Thus, the investigators will harvest between 25 and 30 cc of adipose tissue from each patient. The tissue will be processed immediately and 7cc will be injected. Any remaining adipose tissue will be disposed of immediately in biohazardous waste.
Microfragmented Adipose Tissue (Lipogems): Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. Lipoaspirate is harvested most commonly from the abdomen and washed in saline solution, then processed through a closed-system device that micro-fragments the adipose tissue. This mechanical process retains the vascular architecture, mature pericytes, and MSCs for autologous injection. Lipogems is currently FDA-approved for orthopedic and arthroscopic procedures; thus, this would be an on-label use for knee injections.
|
|---|---|---|---|
|
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Over Time
|
8 units on a scale in comparison to placeb
Interval 6.0 to 11.0
|
13.9 units on a scale in comparison to placeb
Interval -2.8 to 29.2
|
27.8 units on a scale in comparison to placeb
Interval 19.4 to 37.5
|
Adverse Events
Placebo Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Corticosteroid Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lipogems Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Injection
n=22 participants at risk
Patients who are randomized to the placebo group will receive an injection of 7cc of sterile saline in the affected knee.
Saline: Sterile saline injection will act as a placebo group.
|
Corticosteroid Injection
n=23 participants at risk
Patients who are randomized to the corticosteroid group will receive an injection of 2cc (80mg) of triamcinalone acetonide injectable suspension mixed with 5 cc of 1% plain lidocaine for a total of 7cc of fluid injected in the affected knee.
Corticosteroid injection: Cortisone is a standard of care injection to reduce joint inflammation.
|
Lipogems Injection
n=23 participants at risk
Patients who are randomized to the Lipogems treatment group will undergo a lipoaspiration from their abdomen and autologous injection of the harvested adipocytes into their knee. It is standard to harvest three to four times more adipose tissue than is planned to be injected to account for tissue processing by the Lipogems device. The investigators plan to inject 7cc of autologous adipose tissue. Thus, the investigators will harvest between 25 and 30 cc of adipose tissue from each patient. The tissue will be processed immediately and 7cc will be injected. Any remaining adipose tissue will be disposed of immediately in biohazardous waste.
Microfragmented Adipose Tissue (Lipogems): Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. Lipoaspirate is harvested most commonly from the abdomen and washed in saline solution, then processed through a closed-system device that micro-fragments the adipose tissue. This mechanical process retains the vascular architecture, mature pericytes, and MSCs for autologous injection. Lipogems is currently FDA-approved for orthopedic and arthroscopic procedures; thus, this would be an on-label use for knee injections.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Expected minor adverse event
|
0.00%
0/22 • 1 year
|
0.00%
0/23 • 1 year
|
0.00%
0/23 • 1 year
|
Additional Information
Dustin Richter, MD; Vice Chair of Research
University of New Mexico Health Sciences Center
Phone: 505-272-4107
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place