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Clinical Trials in Italy / NCT06890247
Starting soon Observational

Single-Dose Hybrid Hyaluronic Acid and Sodium Chondroitin with Rehabilitation for Sports Adults with Knee Osteoarthritis

NCT06890247 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Palermo
Phase
Observational
Started
2025-05
Last updated
2025-03-21

Condition(s) studied

Osteoarthritis, Knee

Study 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 of biotechnological origin, combined with rehabilitation treatment, in sports adults with moderate to severe knee osteoarthritis. Additionally, the study incorporates isokinetic testing to assess muscle strength and functional capacity.

The primary objective is to determine whether this combined treatment improves pain relief, functional capacity, and overall quality of life compared to rehabilitation treatment alone. Participants aged 18 to 50 years, diagnosed with knee osteoarthritis, will be recruited from clinics at the U.O.C. of Recovery and Functional Rehabilitation at A.O.U.P. P. Giaccone in Palermo. Participants will be divided into two groups: one receiving the hybrid hyaluronic acid and sodium chondroitin injection along with rehabilitation, and the other receiving only rehabilitation. The study will also utilize isokinetic testing to provide objective measurements of muscle strength and endurance.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

  • Change from Baseline in Pain Levels Assessed by the Numerical Rating Scale (NRS) at 90 Days — From baseline (T0) to 90 days (T3) post-intervention
    The primary outcome will assess the change in pain intensity using the Numerical Rating Scale (NRS). This scale ranges from 0 to 10, where 0 indicates no pain and 10 represents the worst possible pain. Pain intensity will be measured at baseline (T0) and at 90 days (T3) following the intervention. The change in NRS scores between these time points will quantify the treatment's effectiveness in reducing knee pain among study participants. Participants with a clinically meaningful reduction in pain (defined as a decrease of at least 2 points on the NRS) will be considered responders.

Trial sites (1)

FacilityCityRegionStatus
A.O.U.P. P. Giaccone, Palermo, Italia Palermo Italia

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06890247 on ClinicalTrials.gov ↗ ← All trials in Italy