Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT05450458
Status:
COMPLETED
Last Update Posted:
2025-07-22
First Post:
2022-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Hyaluronic Acid in Overuse Knee Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}, {'id': 'D055676', 'term': 'Viscosupplementation'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007270', 'term': 'Injections, Intra-Articular'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'activeknee@gmail.com', 'phone': '5215518338063', 'title': 'Dr. Julio Carlos Vélez de Lachica', 'organization': 'RodillaActiva Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during the 6-month intervention period for each participant.', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Athletes With Overuse Knee Syndrome', 'description': '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..', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'KOOS Score', 'description': '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.'}], 'classes': [{'title': 'KOOS Basal', 'categories': [{'measurements': [{'value': '68', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': 'KOOS 15 days', 'categories': [{'measurements': [{'value': '78', 'spread': '8.27', 'groupId': 'OG000'}]}]}, {'title': 'KOOS 3 Months', 'categories': [{'measurements': [{'value': '84', 'spread': '8.78', 'groupId': 'OG000'}]}]}, {'title': 'KOOS 6 Months', 'categories': [{'measurements': [{'value': '88', 'spread': '7.63', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Median Change Baseline to month 6', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.23', 'pValueComment': 'P-values were adjusted for multiple comparisons using the Bonferroni method, and the a priori threshold for statistical significance was set at 0.05.', 'estimateComment': 'The value represents the intra-individual median KOOS improvement from baseline to month 6 after treatment. Changes were evaluated across time points within a single cohort.', 'groupDescription': "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.", 'statisticalMethod': 'Friedman Test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Post hoc pairwise comparisons were adjusted using the Bonferroni method, and the a priori significance level was set at 0.05', 'nonInferiorityComment': '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 KOOS 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'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 15 days, 3 months, and 6 months', 'description': '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:\n\n\\- 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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the International Knee Documentation Committee Score (IKDC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IKDC SCORE', 'description': '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 IKDC score.'}], 'classes': [{'title': 'IKDC basal', 'categories': [{'measurements': [{'value': '65', 'spread': '10.60', 'groupId': 'OG000'}]}]}, {'title': 'IKDC 15 DAYS', 'categories': [{'measurements': [{'value': '74', 'spread': '11.05', 'groupId': 'OG000'}]}]}, {'title': 'IKDC 3 MONTHS', 'categories': [{'measurements': [{'value': '81', 'spread': '8.91', 'groupId': 'OG000'}]}]}, {'title': 'IKDC 6 MONTHS', 'categories': [{'measurements': [{'value': '83', 'spread': '8.88', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000'], 'paramType': 'Median Baseline to Month 6', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '0.12', 'ciUpperLimit': '0.24', 'pValueComment': 'P-values were adjusted for multiple comparisons using the Bonferroni method, and the a priori threshold for statistical significance was set at 0.05.', 'estimateComment': '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.', 'groupDescription': "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.", 'statisticalMethod': 'Friedman Test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The overall p-value is unadjusted. The a priori significance level was set at 0.05 to robustly control the Type I error', 'nonInferiorityComment': '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'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 15 days, 3 months, and 6 months', 'description': '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."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Safety of Hyaluronic Acid With Sorbitol (SYNOLIS VA ®) in Overuse Knee Syndrome by the Number of Adverse Effects in Participants.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Athletes With Overuse Knee Syndrome', 'description': '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. 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. No adverse events were observed in any case.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Six-Month Functional Improvement in Knee Function (IKDC and KOOS) in Athletes With Overuse Knee Syndrome With Elevated BMI Following Synolis VA Injections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMI Elevated IKDC Score', 'description': '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 International Knee Documentation Committee Scale (IKDC) to evaluate changes in knee functionality over time'}, {'id': 'OG001', 'title': 'BMI Elevated KOOS Score', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.1', 'groupId': 'OG000', 'lowerLimit': '79.9', 'upperLimit': '86.1'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '81', 'upperLimit': '91'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'paramType': 'Baseline to month 6', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.21', 'pValueComment': 'P-values from pairwise comparisons were adjusted using the Bonferroni method to control for multiple testing. The global p-value from the Friedman test was not adjusted. An a priori threshold for statistical significance was set at p \\< 0.05', 'estimateComment': '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).', 'groupDescription': '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.', 'statisticalMethod': 'Wilcoxon Signed-Rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Friedman test conducted with 3 degrees of freedom. Bonferroni correction applied in pairwise Wilcoxon post hoc comparisons.', 'nonInferiorityComment': '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'}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'paramType': 'Baseline to Month 6', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.5', 'ciLowerLimit': '13', 'ciUpperLimit': '22', 'pValueComment': 'The p-values reported were not adjusted for multiple comparisons, and the a priori threshold for statistical significance was set at p \\< 0.05', 'estimateComment': '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.', 'groupDescription': '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', 'statisticalMethod': 'Wilcoxon Signed-Rank Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Friedman test conducted with 3 degrees of freedom. Bonferroni correction applied in pairwise Wilcoxon post hoc comparisons.', 'nonInferiorityComment': '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'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months post-treatment', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Athletes With Overuse Knee Syndrome', 'description': '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..'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Athletes With Overuse Knee Syndrome', 'description': '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.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '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.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'IKDC baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '65', 'spread': '10.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "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", 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'KOOS baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68', 'spread': '10.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24', 'spread': '3.18', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'body mass index at baseline', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Primary sport', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'categories': [{'title': 'running', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'tennis', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'hiit', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'aerobics', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'grit', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'weight lifting', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'crossfit', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'montain biker', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'soccer', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'jazz dancer', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'It is defined as the high-level or high-impact sport that the participant engaged in.', 'unitOfMeasure': 'Participants'}, {'title': 'Athlete type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'categories': [{'title': 'SOCIAL', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'AMATEUR', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'PROFESSIONAL', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'If the participant practice a Social, Amateur or Professional sport activity', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-12', 'size': 731068, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-03-11T12:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A study group will be integrated which will be evaluated before the intervention and after 15 days, 3 and 6 subsequent months.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2022-06-17', 'resultsFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2022-07-04', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-01', 'studyFirstPostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'Baseline, 15 days, 3 months, and 6 months', 'description': '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:\n\n\\- 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.'}, {'measure': 'Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the International Knee Documentation Committee Score (IKDC)', 'timeFrame': 'Baseline, 15 days, 3 months, and 6 months', 'description': '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."'}], 'secondaryOutcomes': [{'measure': 'Safety of Hyaluronic Acid With Sorbitol (SYNOLIS VA ®) in Overuse Knee Syndrome by the Number of Adverse Effects in Participants.', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Six-Month Functional Improvement in Knee Function (IKDC and KOOS) in Athletes With Overuse Knee Syndrome With Elevated BMI Following Synolis VA Injections', 'timeFrame': '6 months post-treatment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['KNEE', 'PAIN', 'SPORTSMEN', 'HYALURONIC ACID'], 'conditions': ['Overuse Injury', 'Body Mass Index in Athletes']}, 'referencesModule': {'references': [{'pmid': '28795010', 'type': 'BACKGROUND', 'citation': 'Patel DR, Villalobos A. Evaluation and management of knee pain in young athletes: overuse injuries of the knee. 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JAMA. 2000 May 24-31;283(20):2701-11. doi: 10.1001/jama.283.20.2701.'}], 'seeAlsoLinks': [{'url': 'https://now.aapmr.org/knee-overuse-disorders/', 'label': 'Tiu T, Craig Van Dien MD. Knee overuse disorders'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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).\n\nSynolis 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Patients with knee pain for more than 3 months\n* Patients between 30 and 55 years old\n* Patients without a history of previous knee joint surgery.\n* Patients without chronic-degenerative diseases such as diabetes, hypertension, rheumatoid arthritis or other autoimmune diseases.\n* 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.\n* Patients without a history of allergies to non-steroidal anti-inflammatory drugs.\n* Patients with no history of infection in or around the knee.\n\nExclusion Criteria:\n\n* \\- Patients who cannot be categorized as social athletes.\n* Patients with an associated sports injury that limits their sports practice.\n* Patients who have a treatment associated with knee pain independent of that established in the study protocol.'}, 'identificationModule': {'nctId': 'NCT05450458', 'briefTitle': 'Hyaluronic Acid in Overuse Knee Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Regional Tlalnepantla'}, 'officialTitle': 'Safety and Effectiveness of Hyaluronic Acid and Sorbitol With Overuse Knee Pain in Sportsmen', 'orgStudyIdInfo': {'id': 'CEI/0504/PI/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyaluronic Acid group', 'description': '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).', 'interventionNames': ['Drug: KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA']}], 'interventions': [{'name': 'KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA', 'type': 'DRUG', 'otherNames': ['VISCOSUPPLEMENTATION WITH SYNOLIS VA'], 'description': 'KNEE INFILTRATION WITH HYALURONIC ACID WITH SORBITOL IN SPORTSMEN', 'armGroupLabels': ['Hyaluronic Acid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54055', 'city': 'Tlanepantla', 'country': 'Mexico', 'facility': 'Issemym Tlalnepantla', 'geoPoint': {'lat': 18.8631, 'lon': -97.88701}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Regional Tlalnepantla', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of orthopedic surgery department', 'investigatorFullName': 'Julio Carlos Velez de Lachica', 'investigatorAffiliation': 'Hospital Regional Tlalnepantla'}}}}