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

NCT06890247 NOT_YET_RECRUITING

: 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.

Details

Lead sponsor	University of Palermo
Status	NOT_YET_RECRUITING
Enrolment	100
Start date	2025-05
Completion	2026-01

Conditions

• Osteoarthritis, Knee

Primary outcomes

• 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.

Countries

Italy