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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic Acid group | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA | Drug | KNEE INFILTRATION WITH HYALURONIC ACID WITH SORBITOL IN SPORTSMEN |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 15 days, 3 months, and 6 months |
| 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." | Baseline, 15 days, 3 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Issemym Tlalnepantla | Tlanepantla | 54055 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28795010 | Background | Patel DR, Villalobos A. Evaluation and management of knee pain in young athletes: overuse injuries of the knee. Transl Pediatr. 2017 Jul;6(3):190-198. doi: 10.21037/tp.2017.04.05. | |
| 25061417 | Background | Nicolini AP, de Carvalho RT, Matsuda MM, Sayum JF, Cohen M. Common injuries in athletes' knee: experience of a specialized center. Acta Ortop Bras. 2014;22(3):127-31. doi: 10.1590/1413-78522014220300475. |
| Label | URL |
|---|---|
| Tiu T, Craig Van Dien MD. Knee overuse disorders | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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.. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Athletes diagnosed with knee overuse syndrome were recruited, undergoing a thorough physical exam and ultrasound to rule out ligament, osteochondral, or meniscal injuries. Results of the IKDC scale (International Knee Documentation Committee) and the KOOS scale (Knee injury and Osteoarthritis Outcome Score) were collected over time. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 15 days, 3 months, and 6 months |
Adverse events were collected during the 6-month intervention period for each participant.
The collection included active surveillance for predefined adverse events of interest: skin erythema, joint effusion, localized inflammation, pain, pyrexia (≥38°C), joint infection, and functional impairment after knee injection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julio Carlos Vélez de Lachica | RodillaActiva Medical Center | 5215518338063 | activeknee@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 12, 2023 | Mar 11, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D012090 | Cumulative Trauma Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D055676 | Viscosupplementation |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D007270 | Injections, Intra-Articular |
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A study group will be integrated which will be evaluated before the intervention and after 15 days, 3 and 6 subsequent months.
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|
| 6 months |
| 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. | 6 months post-treatment |
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| 22488286 | Background | Yang J, Tibbetts AS, Covassin T, Cheng G, Nayar S, Heiden E. Epidemiology of overuse and acute injuries among competitive collegiate athletes. J Athl Train. 2012 Mar-Apr;47(2):198-204. doi: 10.4085/1062-6050-47.2.198. |
| 11726474 | Background | Drawer S, Fuller CW. Propensity for osteoarthritis and lower limb joint pain in retired professional soccer players. Br J Sports Med. 2001 Dec;35(6):402-8. doi: 10.1136/bjsm.35.6.402. |
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| 33408876 | Background | Frohlich S, Pazeller S, Cherati AS, Muller E, Frey WO, Sporri J. Overuse injuries in the knee, back and hip of top elite female alpine skiers during the off-season preparation period: prevalence, severity and their association with traumatic preinjuries and training load. BMJ Open Sport Exerc Med. 2020 Dec 24;6(1):e000892. doi: 10.1136/bmjsem-2020-000892. eCollection 2020. |
| 21460071 | Background | Rincon GA, Vyas D, Zhou J, Fu FH, Oiestad BE, Holm I, Aune AK, Gunderson R, Myklebust G, Engebretsen L, Fosdahl M, Risberg MA. "Knee function and prevalence of knee osteoarthritis after anterior cruciate ligament reconstruction: a prospective study with 10 to 15 years of follow-up". Letter to the editor. Am J Sports Med. 2011 Apr;39(4):NP3; author reply NP3-4. doi: 10.1177/0363546511403704. No abstract available. |
| 13498604 | Background | KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available. |
| 17472995 | Background | Hunter DJ, Lo GH, Gale D, Grainger AJ, Guermazi A, Conaghan PG. The reliability of a new scoring system for knee osteoarthritis MRI and the validity of bone marrow lesion assessment: BLOKS (Boston Leeds Osteoarthritis Knee Score). Ann Rheum Dis. 2008 Feb;67(2):206-11. doi: 10.1136/ard.2006.066183. Epub 2007 May 1. |
| 1623366 | Background | Maffulli N, Regine R, Carrillo F, Minelli S, Beaconsfield T. Ultrasonographic scan in knee pain in athletes. Br J Sports Med. 1992 Jun;26(2):93-6. doi: 10.1136/bjsm.26.2.93. |
| 3741515 | Background | Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816. |
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| 26069577 | Background | Hoemann C, Kandel R, Roberts S, Saris DB, Creemers L, Mainil-Varlet P, Methot S, Hollander AP, Buschmann MD. International Cartilage Repair Society (ICRS) Recommended Guidelines for Histological Endpoints for Cartilage Repair Studies in Animal Models and Clinical Trials. Cartilage. 2011 Apr;2(2):153-72. doi: 10.1177/1947603510397535. |
| 14972335 | Background | Peterfy CG, Guermazi A, Zaim S, Tirman PF, Miaux Y, White D, Kothari M, Lu Y, Fye K, Zhao S, Genant HK. Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee in osteoarthritis. Osteoarthritis Cartilage. 2004 Mar;12(3):177-90. doi: 10.1016/j.joca.2003.11.003. |
| 11706459 | Background | Leslie M. Knee osteoarthritis management therapies. Pain Manag Nurs. 2000 Jun;1(2):51-7. doi: 10.1053/jpmn.2000.7782. |
| 24274853 | Background | Demange MK, Sisto M, Rodeo S. Future trends for unicompartmental arthritis of the knee: injectables & stem cells. Clin Sports Med. 2014 Jan;33(1):161-74. doi: 10.1016/j.csm.2013.06.006. Epub 2013 Jul 19. |
| 10364912 | Background | Sandmark H, Hogstedt C, Lewold S, Vingard E. Osteoarthrosis of the knee in men and women in association with overweight, smoking, and hormone therapy. Ann Rheum Dis. 1999 Mar;58(3):151-5. doi: 10.1136/ard.58.3.151. |
| 19447940 | Background | Fransen M, McConnell S. Land-based exercise for osteoarthritis of the knee: a metaanalysis of randomized controlled trials. J Rheumatol. 2009 Jun;36(6):1109-17. doi: 10.3899/jrheum.090058. Epub 2009 May 15. |
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| Count of Participants |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| IKDC baseline | This score is derived from the patient's responses in the IKDC scale (International Knee Documentation Committee) measures knee function with a scoring range from 0 to 87, where 87 represents 100% function (best possible outcome) and 0 represents the worst function. In this study, results are presented as percentages rather than raw score points | Mean | Standard Deviation | percentage |
|
| KOOS baseline | The KOOS scale (Knee injury and Osteoarthritis Outcome Score) is used to assess knee-related quality of life, symptoms, pain, activities of daily living, and sport/recreation function, with scores ranging from 0 to 100, where higher scores indicate better knee health. | Mean | Standard Deviation | percentage |
|
| BMI | body mass index at baseline | Mean | Standard Deviation | kg/m² |
|
| Primary sport | It is defined as the high-level or high-impact sport that the participant engaged in. | Count of Participants | Participants |
|
| Athlete type | If the participant practice a Social, Amateur or Professional sport activity | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | KOOS Score | 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. |
|
|
|
| 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." | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline, 15 days, 3 months, and 6 months |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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. | 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 | Posted | Median | Inter-Quartile Range | score on a scale | 6 months post-treatment |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
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Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007267 |
| Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D019637 | Orthopedic Procedures |
| Title | Measurements |
|---|---|
|
| IKDC 6 MONTHS |
|
This value represents the intra-individual median IKDC improvement from baseline to 6 months after treatment. The analysis was conducted within a single cohort without comparator arms. |
| Other |
This study assessed longitudinal effects within a single patient group. Statistical power was calculated using a significance level of 0.05, 80% power, and 60 patients, accounting for IKDC score variability over time. The Friedman test was applied with post hoc analyses (Conover and Bonferroni). Since treatments were not compared, no non-inferiority or equivalence margin was defined |
Median IKDC improvement from baseline to 6 months in 22 athletes with elevated BMI (≥25). No comparator group was used. Confidence interval calculated via bootstrap (resampling with 1,000 iterations). |
| Superiority |
This is a superiority analysis. Data normality was first assessed with the Shapiro-Wilk test, and due to non-normal distributions, a Wilcoxon Signed-Rank Test was applied to compare paired baseline and six-month IKDC score |
| 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 level | Wilcoxon Signed-Rank Test | Friedman test conducted with 3 degrees of freedom. Bonferroni correction applied in pairwise Wilcoxon post hoc comparisons. | <0.001 | The p-values reported were not adjusted for multiple comparisons, and the a priori threshold for statistical significance was set at p < 0.05 | Baseline to Month 6 | 18.5 | 2-Sided | 95 | 13 | 22 | Median KOOS improvement from baseline to 6 months in 22 athletes with elevated BMI. CI calculated via bootstrap resampling (1,000 iterations). No comparator group was involved. | Superiority | This is a superiority analysis. Data normality was first assessed with the Shapiro-Wilk test, and due to non-normal distributions, a Wilcoxon Signed-Rank Test was applied to compare paired baseline and six-month KOOS score |