Hyaluronic acid and chondroitin injection plus rehabilitation for knee osteoarthritis in active adults
Compares an injection plus rehabilitation with rehabilitation alone in sporty adults with knee osteoarthritis.
Key facts
- Who runs it
- University of Palermo
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Single-Dose Hybrid Hyaluronic Acid and Sodium Chondroitin with Rehabilitation for Sports Adults with Knee Osteoarthritis
- Status
- Not yet recruiting
- People taking part
- 100 people, planned
- Started
- May 2025
- Planned end
- Jan 2026
- Type of study
- Observational
- Record updated
- 21 March 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for active, sporty adults with knee osteoarthritis whose pain limits their sports performance. It compares a single knee injection plus rehabilitation with rehabilitation alone.
- Age
- 18 to 50 years
- Sex
- All sexes
- Disease stage
- Knee osteoarthritis confirmed on X-ray, Kellgren-Lawrence grade ≤3, present for at least 6 months. Ongoing moderate to severe pain that limits physical performance, with a documented drop in sports performance.
- Earlier treatment
- Medicines or other non-surgical treatments must not have worked. No joint lubricant injection (viscosupplementation) in the knee in the last 6 months. No corticosteroids by mouth or into the knee in the last 3 months.
Main reasons for not taking part
- Other rheumatic diseases
- Body Mass Index (BMI) ≥ 30 kg/m²
- Long-term use of painkillers, NSAIDs or narcotics
- Allergy to hyaluronic acid or its components
- Pregnant or breastfeeding, or not using reliable birth control
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- History of intra-articular viscosupplementation in the target knee within the previous 6 months
- Use of systemic or intra-articular corticosteroids in the target knee within the last 3 months
- Coexisting rheumatic diseases
- History of alcohol or drug abuse
- Allergy or hypersensitivity to hyaluronic acid or any of its components
- Presence of significant venous or lymphatic stasis
- Body Mass Index (BMI) ≥ 30 kg/m²
- Chronic use of topical/systemic analgesics, NSAIDs, or narcotics
- Pregnant or breastfeeding women, or those not using adequate contraception
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
: 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.
Read full original descriptionShow less
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Single-dose Intra-Articular of a Hybrid Purified Hyaluronic Acid with a High Molecular Weight and Sodium Chondroitin of Biotechnological Origin in Combination with Rehabilitation Treatment in Sports Adults with Osteoarthritis of the Knee
- Plain-language title
- Hyaluronic acid and chondroitin injection plus rehabilitation for knee osteoarthritis in active adultsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT06890247, who can take part
- Record updated
- 21 March 2025