Phase 3
N=64
Hyaluronic Acid in Overuse Knee Pain
Overuse Injury · Body Mass Index in Athletes
Bottom Line
View on ClinicalTrials.gov: NCT05450458 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the Knee Injury and Osteoarthritis Outcome Score (KOOS) — 68; 78; 84; 88 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA (Drug)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- Hospital Regional Tlalnepantla
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the Knee Injury and Osteoarthritis Outcome Score (KOOS) |
68; 78; 84; 88 | <0.001 sig |
| PRIMARY Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the International Knee Documentation Committee Score (IKDC) |
65; 74; 81; 83 | 0.01 sig |
| SECONDARY Safety of Hyaluronic Acid With Sorbitol (SYNOLIS VA ®) in Overuse Knee Syndrome by the Number of Adverse Effects in 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 |
83.1; 85 | 0.001 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05450458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.