Status:
NOT_YET_RECRUITING
Single-Dose Hybrid Hyaluronic Acid and Sodium Chondroitin with Rehabilitation for Sports Adults with Knee Osteoarthritis
Lead Sponsor:
University of Palermo
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18-50 years
Brief Summary
: This observational case-control study aims to evaluate the efficacy of a single-dose intra-articular injection of a hybrid purified hyaluronic acid with high molecular weight and sodium chondroitin ...
Eligibility Criteria
Inclusion
- Adults aged between 18 and 50 years.
- Radiologically confirmed diagnosis of knee osteoarthritis (Kellgren-Lawrence grade ≤3), present for at least 6 months.
- Persistent moderate to severe pain due to osteoarthritis, interfering with physical performance.
- Documented reduction in sports performance (use appropriate scales or tests to validate this).
- Lack of response to pharmacological or other conservative treatments.
- Willingness to provide written informed consent for participation.
Exclusion
- Coexisting rheumatic diseases.
- History of intra-articular viscosupplementation in the target knee within the previous 6 months.
- Presence of significant venous or lymphatic stasis.
- Body Mass Index (BMI) ≥ 30 kg/m².
- Use of systemic or intra-articular corticosteroids in the target knee within the last 3 months.
- Chronic use of topical/systemic analgesics, NSAIDs, or narcotics.
- History of alcohol or drug abuse.
- Allergy or hypersensitivity to hyaluronic acid or any of its components.
- Pregnant or breastfeeding women, or those not using adequate contraception.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06890247
Start Date
May 1 2025
End Date
January 1 2026
Last Update
March 21 2025
Active Locations (1)
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1
A.O.U.P. P. Giaccone, Palermo, Italia
Palermo, Italia, Italy, 90127