Clinical trial NCT06890247: Single-Dose Hybrid Hyaluronic Acid and Sodium Chondroitin with Rehabilitation for Sports Adults with Knee Osteoarthritis
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Knee
Hyaluronic Acid
Sodium Chondroitin
Rehabilitation
Sports Adults
Isokinetic Testing
Pain Relief
Functional Improvement
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the outpatient clinics of the Unit of Recovery and Functional Rehabilitation at the A.O.U.P. P. Giaccone Hospital in Palermo. The study focuses on sports-active adults aged 18 to 50 years with clinically and radiologically confirmed knee osteoarthritis, seeking treatment for moderate to severe pain affecting physical performance.

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.


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.

Primary outcomes:
measure: Change from Baseline in Pain Levels Assessed by the Numerical Rating Scale (NRS) at 90 Days
timeFrame: From baseline (T0) to 90 days (T3) post-intervention
Secondary outcomes:
measure: Change from Baseline in Functional Capacity Assessed by Lequesne Index at 30 and 90 Days
timeFrame: Baseline (T0), 30 days (T2), and 90 days (T3).
measure: Change from Baseline in Quality of Life Assessed by SF-12 Questionnaire
timeFrame: Baseline (T0) and 90 days (T3).
measure: Change from Baseline in Muscle Strength Evaluated with Isokinetic Testing
timeFrame: Baseline (T0) and 90 days (T3).
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: A.O.U.P. P. Giaccone, Palermo, Italia
state: Italia
Study officials:
References: