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

NCT ID: NCT06890247

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-01-31

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 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.

Conditions

Osteoarthritis, Knee

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Palermo

OTHER

Sponsor Role: lead

Responsible Party

Prof.ssa Giulia Letizia Mauro

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Palermo, Italia, Italy

Countries

Italy

Central Contacts

Professor

Role: CONTACT

giulia.letiziamauro@unipa.it

+39 0916554160 / +39 09165541

Facility Contacts

Letizia Mauro, Professor

Role: primary

giulia.letiziamauro@unipa.it

00390916554160

Other Identifiers

MFR042025

Identifier Type: -

Identifier Source: org_study_id