Osteoarthritis, KneeNCT06890247
Single-Dose Hybrid Hyaluronic Acid and Sodium Chondroitin with Rehabilitation for Sports Adults with Knee Osteoarthritis
An observational study of Osteoarthritis, Knee, run by University of Palermo at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Osteoarthritis, Knee
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- May 2025to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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 join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
A.O.U.P. P. Giaccone, Palermo, Italia
Palermo, Italia, 90127
Letizia Mauro, Professor, 00390916554160, giulia.letiziamauro@unipa.it
About this study
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
: 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
- Keywords
- Osteoarthritis, Knee, Hyaluronic Acid, Sodium Chondroitin, Rehabilitation, Sports Adults, Isokinetic Testing, Pain Relief, Functional Improvement
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pain Levels Assessed by the Numerical Rating Scale (NRS) at 90 Days
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.
Measured: From baseline (T0) to 90 days (T3) post-intervention
Secondary outcomes (3)
Change from Baseline in Functional Capacity Assessed by Lequesne Index at 30 and 90 Days
Evaluation of changes in the Lequesne Index, a validated tool that measures functional disability in knee osteoarthritis patients. The index assesses pain, maximum walking distance, and daily activities. Scores range from 0 (no disability) to a maximum score indicating severe disability. Higher scores denote worse functional impairment. Measurements will be recorded at baseline (T0), 30 days (T2), and 90 days (T3).
Measured: Baseline (T0), 30 days (T2), and 90 days (T3).
Change from Baseline in Quality of Life Assessed by SF-12 Questionnaire
Assessment of changes in quality of life using the SF-12 Health Survey, which evaluates both physical and mental health components. The SF-12 generates composite scores for these domains, with higher scores indicating better quality of life. Measurements will be taken at Baseline (T0) and compared to 90 days (T3) post-intervention to assess the impact of the treatment.
Measured: Baseline (T0) and 90 days (T3).
Change from Baseline in Muscle Strength Evaluated with Isokinetic Testing
Measurement of muscle strength parameters, including peak torque, endurance, and total work of the knee flexor and extensor muscles, using isokinetic dynamometry. Testing will be performed at three angular velocities (0°, 60°, and 120°/sec). Data collected at Baseline (T0) will be compared to follow-up measurements at 90 days (T3) to evaluate the functional improvement in muscle performance.
Measured: Baseline (T0) and 90 days (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study startMay 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.ssa Giulia Letizia Mauro, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890247
- Sponsor's protocol ID
- MFR042025
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06890247
- Acronym / sponsor ID
- MFR042025
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Hyaluronic Acid, Sodium Chondroitin, Rehabilitation, Sports Adults, Isokinetic Testing, Pain Relief
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
: 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in Pain Levels Assessed by the Numerical Rating Scale (NRS) at 90 Days
Time frame: 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.
3 secondary outcomes
Change from Baseline in Functional Capacity Assessed by Lequesne Index at 30 and 90 Days
Time frame: Baseline (T0), 30 days (T2), and 90 days (T3).
Change from Baseline in Quality of Life Assessed by SF-12 Questionnaire
Time frame: Baseline (T0) and 90 days (T3).
Change from Baseline in Muscle Strength Evaluated with Isokinetic Testing
Time frame: Baseline (T0) and 90 days (T3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor (+39 0916554160 / +39 09165541, giulia.letiziamauro@unipa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pain Levels Assessed by the Numerical Rating Scale (NRS) at 90 Days (time frame: From baseline (T0) to 90 days (T3) post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.