Trial Outcomes & Findings for Study on the Use of a Concentrated Growth Factor Preparation Kit for the Treatment of Knee Osteoarthritis (NCT NCT06869200)
NCT ID: NCT06869200
Last Updated: 2026-07-07
Results Overview
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is used to assess pain, stiffness, and physical function in patients with hip and knee osteoarthritis. The score ranges from 0 to 96 (using a 5-point Likert scale), with lower scores indicating better outcomes. Calculated as the absolute value of the difference between the WOMAC score at 1 month and the baseline score: \|Score at 1 month - Score at baseline\|.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
1 month after the 1st injection
Results posted on
2026-07-07
Participant Flow
Participant milestones
| Measure |
CGF Treatment Group
Participants in this arm will receive three intra-articular injections of Concentrated Growth Factor (CGF) prepared using the autologous platelet-rich CGF preparation kit. The injections will be administered at weekly intervals over a period of three weeks.
Concentrated Growth Factor (CGF) Intra-articular Injection: Preparation Method: The CGF is prepared using an autologous platelet-rich preparation kit specifically designed to concentrate growth factors from the patient's own blood. The process involves a specialized centrifugation technique that yields a high concentration of growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), and other bioactive molecules.
Rationale: This intervention leverages the body's natural healing response by utilizing autologous growth factors to enhance the repair of cartilage and other joint tissues affected by osteoarthritis. The high concentration of bioactive molecules in CGF is believed to provide a more potent therapeutic effect compared to other platelet-rich therapies.
|
PRP Treatment Group
Participants in this arm will receive three intra-articular injections of Platelet-Rich Plasma (PRP) prepared using a disposable PRP preparation device. The injections will be administered at weekly intervals over a period of three weeks.
Platelet-Rich Plasma (PRP) Intra-articular Injection: Preparation Method: The PRP is prepared using a disposable PRP preparation device that separates and concentrates platelets from the patient's blood. This process enriches the plasma with platelets and associated growth factors.
Rationale: PRP has been widely used in clinical practice for its ability to promote tissue healing and reduce inflammation in osteoarthritis. It serves as an active comparator in this study, allowing for a direct comparison of the therapeutic efficacy and safety profile of CGF against a well-established treatment modality.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
51
|
|
Overall Study
COMPLETED
|
51
|
49
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
CGF Treatment Group
Participants in this arm will receive three intra-articular injections of Concentrated Growth Factor (CGF) prepared using the autologous platelet-rich CGF preparation kit. The injections will be administered at weekly intervals over a period of three weeks.
Concentrated Growth Factor (CGF) Intra-articular Injection: Preparation Method: The CGF is prepared using an autologous platelet-rich preparation kit specifically designed to concentrate growth factors from the patient's own blood. The process involves a specialized centrifugation technique that yields a high concentration of growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), and other bioactive molecules.
Rationale: This intervention leverages the body's natural healing response by utilizing autologous growth factors to enhance the repair of cartilage and other joint tissues affected by osteoarthritis. The high concentration of bioactive molecules in CGF is believed to provide a more potent therapeutic effect compared to other platelet-rich therapies.
|
PRP Treatment Group
Participants in this arm will receive three intra-articular injections of Platelet-Rich Plasma (PRP) prepared using a disposable PRP preparation device. The injections will be administered at weekly intervals over a period of three weeks.
Platelet-Rich Plasma (PRP) Intra-articular Injection: Preparation Method: The PRP is prepared using a disposable PRP preparation device that separates and concentrates platelets from the patient's blood. This process enriches the plasma with platelets and associated growth factors.
Rationale: PRP has been widely used in clinical practice for its ability to promote tissue healing and reduce inflammation in osteoarthritis. It serves as an active comparator in this study, allowing for a direct comparison of the therapeutic efficacy and safety profile of CGF against a well-established treatment modality.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Alternative treatment (scheduled knee surgery preventing required follow-up)
|
0
|
1
|
Baseline Characteristics
Lost to follow-up
Baseline characteristics by cohort
| Measure |
CGF Treatment Group
n=53 Participants
Participants in this arm will receive three intra-articular injections of Concentrated Growth Factor (CGF) prepared using the autologous platelet-rich CGF preparation kit. The injections will be administered at weekly intervals over a period of three weeks.
|
PRP Treatment Group
n=51 Participants
Participants in this arm will receive three intra-articular injections of Platelet-Rich Plasma (PRP) prepared using a disposable PRP preparation device. The injections will be administered at weekly intervals over a period of three weeks.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 10.43 • n=53 Participants • Lost to follow-up
|
60.3 years
STANDARD_DEVIATION 7.99 • n=51 Participants • Lost to follow-up
|
61.2 years
STANDARD_DEVIATION 9.31 • n=104 Participants • Lost to follow-up
|
|
Sex: Female, Male
Female
|
38 Participants
n=53 Participants • Lost to follow-up
|
36 Participants
n=51 Participants • Lost to follow-up
|
74 Participants
n=104 Participants • Lost to follow-up
|
|
Sex: Female, Male
Male
|
15 Participants
n=53 Participants • Lost to follow-up
|
15 Participants
n=51 Participants • Lost to follow-up
|
30 Participants
n=104 Participants • Lost to follow-up
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
WOMAC score
|
51.8 points
STANDARD_DEVIATION 11.48 • n=53 Participants
|
51.8 points
STANDARD_DEVIATION 9.12 • n=51 Participants
|
51.8 points
STANDARD_DEVIATION 10.34 • n=104 Participants
|
|
VAS score
|
6.04 points
STANDARD_DEVIATION 1.079 • n=53 Participants
|
6.21 points
STANDARD_DEVIATION 0.836 • n=51 Participants
|
6.12 points
STANDARD_DEVIATION 0.967 • n=104 Participants
|
PRIMARY outcome
Timeframe: 1 month after the 1st injectionPopulation: Full Analysis Set (FAS), including all randomized participants who received at least one dose of study treatment and had at least one post-baseline assessment. Missing primary efficacy endpoints were filled using the Last Carryover Count (LOCF) method.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is used to assess pain, stiffness, and physical function in patients with hip and knee osteoarthritis. The score ranges from 0 to 96 (using a 5-point Likert scale), with lower scores indicating better outcomes. Calculated as the absolute value of the difference between the WOMAC score at 1 month and the baseline score: \|Score at 1 month - Score at baseline\|.
Outcome measures
| Measure |
CGF Treatment Group
n=53 Participants
Participants in this arm will receive three intra-articular injections of Concentrated Growth Factor (CGF) prepared using the autologous platelet-rich CGF preparation kit. The injections will be administered at weekly intervals over a period of three weeks.
|
PRP Treatment Group
n=51 Participants
Participants in this arm will receive three intra-articular injections of Platelet-Rich Plasma (PRP) prepared using a disposable PRP preparation device. The injections will be administered at weekly intervals over a period of three weeks.
|
|---|---|---|
|
Absolute Change in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
|
29.6 points
Standard Deviation 12.69
|
19.5 points
Standard Deviation 8.10
|
SECONDARY outcome
Timeframe: 2 months after the 1st injectionCalculated as the absolute value of the difference between the WOMAC score at 2 months and the baseline score: \|Score at 2 months - Score at baseline\|.
Outcome measures
| Measure |
CGF Treatment Group
n=51 Participants
Participants in this arm will receive three intra-articular injections of Concentrated Growth Factor (CGF) prepared using the autologous platelet-rich CGF preparation kit. The injections will be administered at weekly intervals over a period of three weeks.
|
PRP Treatment Group
n=50 Participants
Participants in this arm will receive three intra-articular injections of Platelet-Rich Plasma (PRP) prepared using a disposable PRP preparation device. The injections will be administered at weekly intervals over a period of three weeks.
|
|---|---|---|
|
Absolute Change in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
|
35.1 points
Standard Deviation 11.98
|
24.4 points
Standard Deviation 9.89
|
SECONDARY outcome
Timeframe: 3 months after the 1st injectionCalculated as the absolute value of the difference between the WOMAC score at 3 months and the baseline score: \|Score at 3 months - Score at baseline\|.
Outcome measures
| Measure |
CGF Treatment Group
n=51 Participants
Participants in this arm will receive three intra-articular injections of Concentrated Growth Factor (CGF) prepared using the autologous platelet-rich CGF preparation kit. The injections will be administered at weekly intervals over a period of three weeks.
|
PRP Treatment Group
n=49 Participants
Participants in this arm will receive three intra-articular injections of Platelet-Rich Plasma (PRP) prepared using a disposable PRP preparation device. The injections will be administered at weekly intervals over a period of three weeks.
|
|---|---|---|
|
Absolute Change in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
|
39.0 points
Standard Deviation 11.46
|
27.2 points
Standard Deviation 11.15
|
SECONDARY outcome
Timeframe: 1 month after the first injectionThe Visual Analog Scale (VAS) is used to measure the intensity of pain experienced by patients. The VAS score ranges from 0 to 10, with lower scores indicating better outcomes (i.e., less pain).
Outcome measures
| Measure |
CGF Treatment Group
n=51 Participants
Participants in this arm will receive three intra-articular injections of Concentrated Growth Factor (CGF) prepared using the autologous platelet-rich CGF preparation kit. The injections will be administered at weekly intervals over a period of three weeks.
|
PRP Treatment Group
n=50 Participants
Participants in this arm will receive three intra-articular injections of Platelet-Rich Plasma (PRP) prepared using a disposable PRP preparation device. The injections will be administered at weekly intervals over a period of three weeks.
|
|---|---|---|
|
Absolute Change in The Visual Analog Scale (VAS) Score
|
3.44 points
Standard Deviation 2.72
|
1.329 points
Standard Deviation 1.067
|
SECONDARY outcome
Timeframe: 2 months after the first injectionThe Visual Analog Scale (VAS) is used to measure the intensity of pain experienced by patients. The VAS score ranges from 0 to 10, with lower scores indicating better outcomes (i.e., less pain). Calculated as the absolute value of the difference between the VAS score at 1month and the baseline score: \|Score at 2 month - Score at baseline\|.
Outcome measures
| Measure |
CGF Treatment Group
n=51 Participants
Participants in this arm will receive three intra-articular injections of Concentrated Growth Factor (CGF) prepared using the autologous platelet-rich CGF preparation kit. The injections will be administered at weekly intervals over a period of three weeks.
|
PRP Treatment Group
n=50 Participants
Participants in this arm will receive three intra-articular injections of Platelet-Rich Plasma (PRP) prepared using a disposable PRP preparation device. The injections will be administered at weekly intervals over a period of three weeks.
|
|---|---|---|
|
Absolute Change in The Visual Analog Scale (VAS) Score
|
3.90 points
Standard Deviation 1.320
|
3.31 points
Standard Deviation 1.343
|
SECONDARY outcome
Timeframe: 3 months after the first injectionThe Visual Analog Scale (VAS) is used to measure the intensity of pain experienced by patients. The VAS score ranges from 0 to 10, with lower scores indicating better outcomes (i.e., less pain). Calculated as the absolute value of the difference between the VAS score at 3 months and the baseline score: \|Score at 3 months - Score at baseline\|.
Outcome measures
| Measure |
CGF Treatment Group
n=51 Participants
Participants in this arm will receive three intra-articular injections of Concentrated Growth Factor (CGF) prepared using the autologous platelet-rich CGF preparation kit. The injections will be administered at weekly intervals over a period of three weeks.
|
PRP Treatment Group
n=49 Participants
Participants in this arm will receive three intra-articular injections of Platelet-Rich Plasma (PRP) prepared using a disposable PRP preparation device. The injections will be administered at weekly intervals over a period of three weeks.
|
|---|---|---|
|
Absolute Change in The Visual Analog Scale (VAS) Score
|
4.19 points
Standard Deviation 1.363
|
3.58 points
Standard Deviation 1.361
|
Adverse Events
CGF Treatment Group
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
PRP Treatment Group
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CGF Treatment Group
n=53 participants at risk
Participants in this arm will receive three intra-articular injections of Concentrated Growth Factor (CGF) prepared using the autologous platelet-rich CGF preparation kit. The injections will be administered at weekly intervals over a period of three weeks.
|
PRP Treatment Group
n=51 participants at risk
Participants in this arm will receive three intra-articular injections of Platelet-Rich Plasma (PRP) prepared using a disposable PRP preparation device. The injections will be administered at weekly intervals over a period of three weeks.
|
|---|---|---|
|
Ear and labyrinth disorders
Benign paroxysmal positional vertigo (BPPV)
|
0.00%
0/53 • from enrollment until end of follow-up, an average of 3 months
|
2.0%
1/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Progression of osteoarthritis in the right knee
|
0.00%
0/53 • from enrollment until end of follow-up, an average of 3 months
|
2.0%
1/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Eye disorders
Age-related cataracts in both eyes
|
1.9%
1/53 • from enrollment until end of follow-up, an average of 3 months
|
0.00%
0/51 • from enrollment until end of follow-up, an average of 3 months
|
Other adverse events
| Measure |
CGF Treatment Group
n=53 participants at risk
Participants in this arm will receive three intra-articular injections of Concentrated Growth Factor (CGF) prepared using the autologous platelet-rich CGF preparation kit. The injections will be administered at weekly intervals over a period of three weeks.
|
PRP Treatment Group
n=51 participants at risk
Participants in this arm will receive three intra-articular injections of Platelet-Rich Plasma (PRP) prepared using a disposable PRP preparation device. The injections will be administered at weekly intervals over a period of three weeks.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/53 • from enrollment until end of follow-up, an average of 3 months
|
2.0%
1/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Gastrointestinal disorders
colorectal polyps
|
1.9%
1/53 • from enrollment until end of follow-up, an average of 3 months
|
0.00%
0/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Gastrointestinal disorders
Oral mucositis
|
1.9%
1/53 • from enrollment until end of follow-up, an average of 3 months
|
0.00%
0/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Gastrointestinal disorders
gastric polyps
|
1.9%
1/53 • from enrollment until end of follow-up, an average of 3 months
|
0.00%
0/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Gastrointestinal disorders
stomach ache
|
0.00%
0/53 • from enrollment until end of follow-up, an average of 3 months
|
2.0%
1/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Infections and infestations
infection
|
1.9%
1/53 • from enrollment until end of follow-up, an average of 3 months
|
2.0%
1/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Eye disorders
retinal degeneration
|
1.9%
1/53 • from enrollment until end of follow-up, an average of 3 months
|
0.00%
0/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
0.00%
0/53 • from enrollment until end of follow-up, an average of 3 months
|
2.0%
1/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Investigations
Elevated aspartate transferase
|
0.00%
0/53 • from enrollment until end of follow-up, an average of 3 months
|
2.0%
1/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Metabolism and nutrition disorders
High blood lipids
|
0.00%
0/53 • from enrollment until end of follow-up, an average of 3 months
|
2.0%
1/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Metabolism and nutrition disorders
diabetes
|
0.00%
0/53 • from enrollment until end of follow-up, an average of 3 months
|
2.0%
1/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
skin papilloma
|
0.00%
0/53 • from enrollment until end of follow-up, an average of 3 months
|
2.0%
1/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
1/53 • from enrollment until end of follow-up, an average of 3 months
|
0.00%
0/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Infections and infestations
abscess
|
1.9%
1/53 • from enrollment until end of follow-up, an average of 3 months
|
0.00%
0/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Infections and infestations
tracheobronchitis
|
1.9%
1/53 • from enrollment until end of follow-up, an average of 3 months
|
0.00%
0/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/53 • from enrollment until end of follow-up, an average of 3 months
|
0.00%
0/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Infections and infestations
vaginal infection
|
0.00%
0/53 • from enrollment until end of follow-up, an average of 3 months
|
2.0%
1/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
7.5%
4/53 • from enrollment until end of follow-up, an average of 3 months
|
0.00%
0/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
stiff joints
|
1.9%
1/53 • from enrollment until end of follow-up, an average of 3 months
|
0.00%
0/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
0.00%
0/53 • from enrollment until end of follow-up, an average of 3 months
|
2.0%
1/51 • from enrollment until end of follow-up, an average of 3 months
|
|
General disorders
injection site pain
|
1.9%
1/53 • from enrollment until end of follow-up, an average of 3 months
|
7.8%
4/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Nervous system disorders
Cerebral ischemia
|
1.9%
1/53 • from enrollment until end of follow-up, an average of 3 months
|
0.00%
0/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Nervous system disorders
drooling
|
1.9%
1/53 • from enrollment until end of follow-up, an average of 3 months
|
0.00%
0/51 • from enrollment until end of follow-up, an average of 3 months
|
|
Nervous system disorders
Lacunar infarction
|
1.9%
1/53 • from enrollment until end of follow-up, an average of 3 months
|
0.00%
0/51 • from enrollment until end of follow-up, an average of 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place