Trial Outcomes & Findings for Hyaluronic Acid in Overuse Knee Pain (NCT NCT05450458)
NCT ID: NCT05450458
Last Updated: 2025-07-22
Results Overview
To demonstrate that two doses of intra-articular injection of Synolis VA® for the overuse knee syndrome in sportsmen decrease the pain during spots and day-living activities by measured the improvement of knee symptoms through the KOOS score: \- The Knee injury and Osteoarthritis Outcome Score: Evaluate Symptoms + Stiffness subtotal, Pain, Function, daily living, sports and recreational activities and quality of life. Each variable has a percentage score from 0 to 100%, at the end the results are averaged, obtaining a final percentage where 100% means a healthy knee with out discomfort. As the percentage approaches 0%, the severity of knee discomfort or injury increases.
COMPLETED
PHASE2/PHASE3
64 participants
Baseline, 15 days, 3 months, and 6 months
2025-07-22
Participant Flow
Participant milestones
| Measure |
Athletes With Overuse Knee Syndrome
Patients who are considered athletes of moderate or high impact activities are those who practice a sport of this type at least 3 times per week for at least 1 hour, and who also experience knee pain related to the sports activity..
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|---|---|
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Overall Study
STARTED
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64
|
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Overall Study
COMPLETED
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60
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Athletes With Overuse Knee Syndrome
Patients who are considered athletes of moderate or high impact activities are those who practice a sport of this type at least 3 times per week for at least 1 hour, and who also experience knee pain related to the sports activity..
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|---|---|
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Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Athletes With Overuse Knee Syndrome
n=60 Participants
Patients who are considered athletes of moderate or high impact activities are those who practice a sport of this type at least 3 times per week for at least 1 hour, and who also experience knee pain related to the sports activity. The diagnosis was based on clinical evaluation, ultrasound, and X-ray findings. Eligibility criteria included patients aged 30 to 55 years who participate in moderate to high-impact knee sports activities at least three times per week, with a minimum duration of one hour per session; absence of surgical intervention, ligament or meniscal injuries, acute or chronic infections, or sequelae injuries in the pelvic limbs; ability to complete the 6-month follow-up without the use of NSAIDs and full adherence to the study protocol. All participants were treated with two HA-Sorbitol knee injections by the same technique and surgeon and evaluated with the KOOS and IKDC scores over time at baseline, 15 days, 3 months and 6 months.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=60 Participants
|
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Age, Categorical
Between 18 and 65 years
|
60 Participants
n=60 Participants
|
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Age, Categorical
>=65 years
|
0 Participants
n=60 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=60 Participants
|
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Sex: Female, Male
Male
|
24 Participants
n=60 Participants
|
|
Region of Enrollment
Mexico
|
60 participants
n=60 Participants
|
|
IKDC baseline
|
65 percentage
STANDARD_DEVIATION 10.6 • n=60 Participants
|
|
KOOS baseline
|
68 percentage
STANDARD_DEVIATION 10.6 • n=60 Participants
|
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BMI
|
24 kg/m²
STANDARD_DEVIATION 3.18 • n=60 Participants
|
|
Primary sport
running
|
16 Participants
n=60 Participants
|
|
Primary sport
tennis
|
12 Participants
n=60 Participants
|
|
Primary sport
hiit
|
3 Participants
n=60 Participants
|
|
Primary sport
aerobics
|
2 Participants
n=60 Participants
|
|
Primary sport
grit
|
4 Participants
n=60 Participants
|
|
Primary sport
weight lifting
|
4 Participants
n=60 Participants
|
|
Primary sport
crossfit
|
9 Participants
n=60 Participants
|
|
Primary sport
montain biker
|
1 Participants
n=60 Participants
|
|
Primary sport
soccer
|
6 Participants
n=60 Participants
|
|
Primary sport
jazz dancer
|
3 Participants
n=60 Participants
|
|
Athlete type
SOCIAL
|
12 Participants
n=60 Participants
|
|
Athlete type
AMATEUR
|
38 Participants
n=60 Participants
|
|
Athlete type
PROFESSIONAL
|
10 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Baseline, 15 days, 3 months, and 6 monthsPopulation: 60 athletes diagnosed with overuse knee syndrome due to sports were included. Synolis VA was applied as a treatment, and participants were evaluated over time using the KOOS (Knee injury and Osteoarthritis Outcome Score) at basal, 15 days, 3 months and 6 months.
To demonstrate that two doses of intra-articular injection of Synolis VA® for the overuse knee syndrome in sportsmen decrease the pain during spots and day-living activities by measured the improvement of knee symptoms through the KOOS score: \- The Knee injury and Osteoarthritis Outcome Score: Evaluate Symptoms + Stiffness subtotal, Pain, Function, daily living, sports and recreational activities and quality of life. Each variable has a percentage score from 0 to 100%, at the end the results are averaged, obtaining a final percentage where 100% means a healthy knee with out discomfort. As the percentage approaches 0%, the severity of knee discomfort or injury increases.
Outcome measures
| Measure |
KOOS Score
n=60 Participants
All overuse knee syndrome participants after both knee joint infiltration with two doses each of Synolis VA (2ml = 40 milligrams of hyaluronic acid with 80 milligrams of sorbitol). Assessed over time with the KOOS score.
|
BMI Elevated KOOS Score
Athletes with an elevated body mass index (BMI \> 25) who have been diagnosed with overuse knee syndrome and are treated with two intra-articular injections of Synolis VA. Participants in this group are assessed at baseline and again at six months using the Knee injury and Osteoarthritis Outcome Score (KOOS) to evaluate changes over knee related quality of life, symptoms, pain, activities of daily living, and sport/recreation function over time.
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|---|---|---|
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Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS Basal
|
68 score on a scale
Standard Deviation 10.6
|
—
|
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Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS 15 days
|
78 score on a scale
Standard Deviation 8.27
|
—
|
|
Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS 3 Months
|
84 score on a scale
Standard Deviation 8.78
|
—
|
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Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS 6 Months
|
88 score on a scale
Standard Deviation 7.63
|
—
|
PRIMARY outcome
Timeframe: Baseline, 15 days, 3 months, and 6 monthsPopulation: IKDC score was collected from 60 participants after the knee injection with two doses of synolis VA, basal, 15 days, 3 months and 6 months
To evaluate the effectiveness of two intra-articular injections of Synolis VA in improving knee functionality in athletes with overuse knee syndrome, the International Knee Documentation Committee (IKDC) Scale was used. This validated tool assesses knee function, symptoms, and the ability to perform sports-related activities. It consists of individual items evaluating pain, stiffness, swelling, instability, daily physical function, and athletic performance. While the scale's raw score ranges from 0 to 87, results are converted into a percentage format, where 87 corresponds to 100% functional capacity-the best possible knee function-and 0 represents the worst condition."
Outcome measures
| Measure |
KOOS Score
n=60 Participants
All overuse knee syndrome participants after both knee joint infiltration with two doses each of Synolis VA (2ml = 40 milligrams of hyaluronic acid with 80 milligrams of sorbitol). Assessed over time with the KOOS score.
|
BMI Elevated KOOS Score
Athletes with an elevated body mass index (BMI \> 25) who have been diagnosed with overuse knee syndrome and are treated with two intra-articular injections of Synolis VA. Participants in this group are assessed at baseline and again at six months using the Knee injury and Osteoarthritis Outcome Score (KOOS) to evaluate changes over knee related quality of life, symptoms, pain, activities of daily living, and sport/recreation function over time.
|
|---|---|---|
|
Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the International Knee Documentation Committee Score (IKDC)
IKDC basal
|
65 score on a scale
Standard Deviation 10.60
|
—
|
|
Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the International Knee Documentation Committee Score (IKDC)
IKDC 15 DAYS
|
74 score on a scale
Standard Deviation 11.05
|
—
|
|
Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the International Knee Documentation Committee Score (IKDC)
IKDC 3 MONTHS
|
81 score on a scale
Standard Deviation 8.91
|
—
|
|
Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the International Knee Documentation Committee Score (IKDC)
IKDC 6 MONTHS
|
83 score on a scale
Standard Deviation 8.88
|
—
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Sixty patients were evaluated after receiving two doses of Synolis VA per knee. Assessments were performed at baseline, 15 days, 3 months, and 6 months.
Evaluate the SYNOLIS VA ® safety after two doses of intra articular injection by tracking the number of patient withdrawals and their adverse events including: skin irritation, knee redness, local pain for more than 24 hours, edema for more than 48 hours and itching at the application site.
Outcome measures
| Measure |
KOOS Score
n=60 Participants
All overuse knee syndrome participants after both knee joint infiltration with two doses each of Synolis VA (2ml = 40 milligrams of hyaluronic acid with 80 milligrams of sorbitol). Assessed over time with the KOOS score.
|
BMI Elevated KOOS Score
Athletes with an elevated body mass index (BMI \> 25) who have been diagnosed with overuse knee syndrome and are treated with two intra-articular injections of Synolis VA. Participants in this group are assessed at baseline and again at six months using the Knee injury and Osteoarthritis Outcome Score (KOOS) to evaluate changes over knee related quality of life, symptoms, pain, activities of daily living, and sport/recreation function over time.
|
|---|---|---|
|
Safety of Hyaluronic Acid With Sorbitol (SYNOLIS VA ®) in Overuse Knee Syndrome by the Number of Adverse Effects in Participants.
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0 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 months post-treatmentPopulation: Analysis includes 22 athletes with a BMI \>25 who had complete baseline and six-month data for both the International Knee Documentation Committee Subjective Knee Evaluation Form and the Knee Injury and Osteoarthritis Outcome Score. Normality was assessed using the Shapiro-Wilk test, and since the data were non-normally distributed, paired comparisons were made using the Wilcoxon Signed-Rank Test
This measure evaluates the change in knee function over a six-month period in athletes with an elevated body mass index (BMI \> 25) diagnosed with overuse knee syndrome and treated with intra-articular injections of Synolis VA®. Two validated patient-reported outcome instruments are used: the International Knee Documentation Committee Subjective Knee Evaluation Form (scale: 0 = poorest function, 100 = best function) and the Knee Injury and Osteoarthritis Outcome Score (scale: 0 = worst outcome, 100 = best outcome). Higher scores indicate better knee functionality. Baseline scores are compared with six-month scores to assess functional improvement.
Outcome measures
| Measure |
KOOS Score
n=22 Participants
All overuse knee syndrome participants after both knee joint infiltration with two doses each of Synolis VA (2ml = 40 milligrams of hyaluronic acid with 80 milligrams of sorbitol). Assessed over time with the KOOS score.
|
BMI Elevated KOOS Score
n=22 Participants
Athletes with an elevated body mass index (BMI \> 25) who have been diagnosed with overuse knee syndrome and are treated with two intra-articular injections of Synolis VA. Participants in this group are assessed at baseline and again at six months using the Knee injury and Osteoarthritis Outcome Score (KOOS) to evaluate changes over knee related quality of life, symptoms, pain, activities of daily living, and sport/recreation function over time.
|
|---|---|---|
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Six-Month Functional Improvement in Knee Function (IKDC and KOOS) in Athletes With Overuse Knee Syndrome With Elevated BMI Following Synolis VA Injections
|
83.1 score on a scale
Interval 79.9 to 86.1
|
85 score on a scale
Interval 81.0 to 91.0
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Adverse Events
Athletes With Overuse Knee Syndrome
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Julio Carlos Vélez de Lachica
RodillaActiva Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place