Body Mass Index in Athletes, Overuse Injury
Conditions
Keywords
KNEE, PAIN, SPORTSMEN, HYALURONIC ACID
Brief summary
Sports activity represents part of day living people, a knee pain originated by high demand joint activity could represent a limitation to continue sports. The aim of this clinical trial is demonstrate the effects of hyaluronic acid in sportsmen with knee pain.
Detailed description
Sports activities have become a fundamental part of our daily life, this has led to an overuse of load joints, being the knee the most relevant. Overuse injuries of the knee result from microtrauma associated with physical activity and exercise that exceeds the strength of the cartilage tissue. The purpose of this study is to evaluate the usefulness and safety of hyaluronic acid in athlete patients with knee overuse syndrome. Investigators hypothesis is that hyaluronic acid y safe and can improve symptoms of knee pain in sports patients. . Scores recorder data will be made at 15 days, then at 3 and 6 months after two knee injections of hyaluronic acid with sorbitol (Synolis VA). Synolis VA is a viscoelastic, sterile, non-pyrogenic, isotonic, buffered solution of 2% hyaluronic acid. The hyaluronic acid used in synolis VA is obtained from bacterial fermentation and has a high molecular weight of 2 mdaltons, it has a neutral pH of 6.8 - 7.4 like synovial fluid. High concentration and high molecular weight of hyaluronic acid combined with sorbitol limits its degradation and confers the capacity of viscoelastic solution to restore joint lubrication and shock absorption properties. This research protocol has been approve by the ethics and research Institutional committee in ISSEMyM Tlalnepantla Estado de Mexico number: CEI/0504/PI./2022. All participants must sign a informed consent to confirm be part fo this study.
Interventions
DRUGKNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA
KNEE INFILTRATION WITH HYALURONIC ACID WITH SORBITOL IN SPORTSMEN
Sponsors
Hospital Regional Tlalnepantla
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A study group will be integrated which will be evaluated before the intervention and after 15 days, 3 and 6 subsequent months.
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* \- Patients with knee pain for more than 3 months * Patients between 30 and 55 years old * Patients without a history of previous knee joint surgery. * Patients without chronic-degenerative diseases such as diabetes, hypertension, rheumatoid arthritis or other autoimmune diseases. * Patients who perform impact social sports at least 3 times a week for more than 1 hour in the last 3 months prior to treatment. * Patients without a history of allergies to non-steroidal anti-inflammatory drugs. * Patients with no history of infection in or around the knee.
Exclusion criteria
* \- Patients who cannot be categorized as social athletes. * Patients with an associated sports injury that limits their sports practice. * Patients who have a treatment associated with knee pain independent of that established in the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline, 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. |
| Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the International Knee Documentation Committee Score (IKDC) | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Hyaluronic Acid With Sorbitol (SYNOLIS VA ®) in Overuse Knee Syndrome by the Number of Adverse Effects in Participants. | 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. |
| Six-Month Functional Improvement in Knee Function (IKDC and KOOS) in Athletes With Overuse Knee Syndrome With Elevated BMI Following Synolis VA Injections | 6 months post-treatment | 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. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. 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. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Athletes With Overuse Knee Syndrome | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 60 Participants | — |
| Athlete type AMATEUR | 38 Participants | — |
| Athlete type PROFESSIONAL | 10 Participants | — |
| Athlete type SOCIAL | 12 Participants | — |
| BMI | 24 kg/m² STANDARD_DEVIATION 3.18 | — |
| IKDC baseline | 65 percentage STANDARD_DEVIATION 10.6 | — |
| KOOS baseline | 68 percentage STANDARD_DEVIATION 10.6 | — |
| Primary sport aerobics | 2 Participants | — |
| Primary sport crossfit | 9 Participants | — |
| Primary sport grit | 4 Participants | — |
| Primary sport hiit | 3 Participants | — |
| Primary sport jazz dancer | 3 Participants | — |
| Primary sport montain biker | 1 Participants | — |
| Primary sport running | 16 Participants | — |
| Primary sport soccer | 6 Participants | — |
| Primary sport tennis | 12 Participants | — |
| Primary sport weight lifting | 4 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Mexico | 60 participants | — |
| Sex: Female, Male Female | 36 Participants | — |
| Sex: Female, Male Male | 24 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the International Knee Documentation Committee Score (IKDC)
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.
Time frame: Baseline, 15 days, 3 months, and 6 months
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KOOS Score | 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 10.6 |
| KOOS Score | 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 |
| KOOS Score | 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 |
| KOOS Score | 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 |
Comparison: The statistical analysis will use the Friedman test, as the Shapiro-Wilk test confirmed a non-normal distribution. Conover's post hoc test with Bonferroni correction will adjust for multiple comparisons. The null hypothesis states that hyaluronic acid injections with sorbitol do not significantly improve IKDC function and pain scores over time. A power analysis was performed to ensure an adequate sample size for detecting clinically meaningful differences.p-value: 0.0195% CI: [0.12, 0.24]Friedman Test
Primary
Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the Knee Injury and Osteoarthritis Outcome Score (KOOS)
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.
Time frame: Baseline, 15 days, 3 months, and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KOOS Score | 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 |
| KOOS Score | 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 |
| KOOS Score | 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 |
| KOOS Score | 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 |
Comparison: The statistical analysis will use the Friedman test, as the Shapiro-Wilk test confirmed a non-normal distribution. Conover's post hoc test with Bonferroni correction will adjust for multiple comparisons. The null hypothesis states that hyaluronic acid injections with sorbitol do not significantly improve KOOS function and pain scores over time. A power analysis was performed to ensure an adequate sample size for detecting clinically meaningful differences.p-value: <0.00195% CI: [0.15, 0.23]Friedman Test
Secondary
Safety of Hyaluronic Acid With Sorbitol (SYNOLIS VA ®) in Overuse Knee Syndrome by the Number of Adverse Effects in Participants.
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| KOOS Score | Safety of Hyaluronic Acid With Sorbitol (SYNOLIS VA ®) in Overuse Knee Syndrome by the Number of Adverse Effects in Participants. | 0 Participants |
Secondary
Six-Month Functional Improvement in Knee Function (IKDC and KOOS) in Athletes With Overuse Knee Syndrome With Elevated BMI Following Synolis VA Injections
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.
Time frame: 6 months post-treatment
Population: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| KOOS Score | 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 |
| BMI Elevated KOOS Score | Six-Month Functional Improvement in Knee Function (IKDC and KOOS) in Athletes With Overuse Knee Syndrome With Elevated BMI Following Synolis VA Injections | 85 score on a scale |
Comparison: The analysis was conducted under the null hypothesis of no change in knee function across time. Data normality was assessed using the Shapiro-Wilk test. Changes across the four time points (baseline, 15 days, 3 months, and 6 months) were evaluated using the Friedman test. Pairwise comparisons were performed post hoc using the Wilcoxon Signed-Rank Test with Bonferroni correction at a 5% significance threshold.p-value: 0.00195% CI: [0.14, 0.21]Wilcoxon Signed-Rank Test
Comparison: The analysis was conducted under the null hypothesis of no change in knee function between baseline and six months. The study was designed with sufficient power to detect clinically meaningful improvements, with significance determined at a conventional levelp-value: <0.00195% CI: [13, 22]Wilcoxon Signed-Rank Test