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Overuse InjuryPhase 2/3NCT05450458

Hyaluronic Acid in Overuse Knee Pain

A Phase 2/3 study testing KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA in people with Overuse Injury and Body Mass Index in Athletes, run by Hospital Regional Tlalnepantla at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Sports activity represents part of day living people, a knee pain originated by high demand joint activity could represent a limitation to continue sports. The aim of this clinical trial is demonstrate the effects of hyaluronic acid in sportsmen with knee pain. Read more about this study

Who is it for?
Ages 30 to 55 years
Conditions the study is for
Overuse Injury, Body Mass Index in Athletes
What is being tested?
KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteMexico
Study dates
1 Feb 2023to 30 Apr 2025
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 30 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • - Patients with knee pain for more than 3 months
  • Patients between 30 and 55 years old
  • Patients without a history of previous knee joint surgery.
  • Patients without chronic-degenerative diseases such as diabetes, hypertension, rheumatoid arthritis or other autoimmune diseases.
  • Patients who perform impact social sports at least 3 times a week for more than 1 hour in the last 3 months prior to treatment.
  • Patients without a history of allergies to non-steroidal anti-inflammatory drugs.
  • Patients with no history of infection in or around the knee.

Who cannot join

  • - Patients who cannot be categorized as social athletes.
  • Patients with an associated sports injury that limits their sports practice.
  • Patients who have a treatment associated with knee pain independent of that established in the study protocol.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Issemym Tlalnepantla

    Tlanepantla, 54055

Other trials in Mexico

About this study

Official title: Safety and Effectiveness of Hyaluronic Acid and Sorbitol With Overuse Knee Pain in Sportsmen

Sports activity represents part of day living people, a knee pain originated by high demand joint activity could represent a limitation to continue sports. The aim of this clinical trial is demonstrate the effects of hyaluronic acid in sportsmen with knee pain.

Read the detailed description

Sports activities have become a fundamental part of our daily life, this has led to an overuse of load joints, being the knee the most relevant. Overuse injuries of the knee result from microtrauma associated with physical activity and exercise that exceeds the strength of the cartilage tissue.

The purpose of this study is to evaluate the usefulness and safety of hyaluronic acid in athlete patients with knee overuse syndrome. Investigators hypothesis is that hyaluronic acid y safe and can improve symptoms of knee pain in sports patients. . Scores recorder data will be made at 15 days, then at 3 and 6 months after two knee injections of hyaluronic acid with sorbitol (Synolis VA).

Synolis VA is a viscoelastic, sterile, non-pyrogenic, isotonic, buffered solution of 2% hyaluronic acid. The hyaluronic acid used in synolis VA is obtained from bacterial fermentation and has a high molecular weight of 2 mdaltons, it has a neutral pH of 6.8 - 7.4 like synovial fluid. High concentration and high molecular weight of hyaluronic acid combined with sorbitol limits its degradation and confers the capacity of viscoelastic solution to restore joint lubrication and shock absorption properties.

This research protocol has been approve by the ethics and research Institutional committee in ISSEMyM Tlalnepantla Estado de Mexico number: CEI/0504/PI./2022. All participants must sign a informed consent to confirm be part fo this study.

Being tested
KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA
Keywords
KNEE, PAIN, SPORTSMEN, HYALURONIC ACID
Medical subject headings
Cumulative Trauma Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VADrug

    Also called VISCOSUPPLEMENTATION WITH SYNOLIS VA

    KNEE INFILTRATION WITH HYALURONIC ACID WITH SORBITOL IN SPORTSMEN

Study groups in NCT05450458
Study groupRoleWhat they receive
Hyaluronic Acid groupExperimentalAll overuse knee syndrome participants after both knee joint infiltration with two doses each of Synolis VA (2ml = 40 milligrams of hyaluronic acid with 80 milligrams of sorbitol).
Receives: Drug: KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the Knee Injury and Osteoarthritis Outcome Score (KOOS)

    To demonstrate that two doses of intra-articular injection of Synolis VA® for the overuse knee syndrome in sportsmen decrease the pain during spots and day-living activities by measured the improvement of knee symptoms through the KOOS score:

    • The Knee injury and Osteoarthritis Outcome Score: Evaluate Symptoms + Stiffness subtotal, Pain, Function, daily living, sports and recreational activities and quality of life. Each variable has a percentage score from 0 to 100%, at the end the results are averaged, obtaining a final percentage where 100% means a healthy knee with out discomfort. As the percentage approaches 0%, the severity of knee discomfort or injury increases.

    Measured: Baseline, 15 days, 3 months, and 6 months

  2. Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the International Knee Documentation Committee Score (IKDC)

    To evaluate the effectiveness of two intra-articular injections of Synolis VA in improving knee functionality in athletes with overuse knee syndrome, the International Knee Documentation Committee (IKDC) Scale was used. This validated tool assesses knee function, symptoms, and the ability to perform sports-related activities. It consists of individual items evaluating pain, stiffness, swelling, instability, daily physical function, and athletic performance. While the scale's raw score ranges from 0 to 87, results are converted into a percentage format, where 87 corresponds to 100% functional capacity-the best possible knee function-and 0 represents the worst condition."

    Measured: Baseline, 15 days, 3 months, and 6 months

Secondary outcomes (2)

  1. Safety of Hyaluronic Acid With Sorbitol (SYNOLIS VA ®) in Overuse Knee Syndrome by the Number of Adverse Effects in Participants.

    Evaluate the SYNOLIS VA ® safety after two doses of intra articular injection by tracking the number of patient withdrawals and their adverse events including: skin irritation, knee redness, local pain for more than 24 hours, edema for more than 48 hours and itching at the application site.

    Measured: 6 months

  2. Six-Month Functional Improvement in Knee Function (IKDC and KOOS) in Athletes With Overuse Knee Syndrome With Elevated BMI Following Synolis VA Injections

    This measure evaluates the change in knee function over a six-month period in athletes with an elevated body mass index (BMI > 25) diagnosed with overuse knee syndrome and treated with intra-articular injections of Synolis VA®. Two validated patient-reported outcome instruments are used: the International Knee Documentation Committee Subjective Knee Evaluation Form (scale: 0 = poorest function, 100 = best function) and the Knee Injury and Osteoarthritis Outcome Score (scale: 0 = worst outcome, 100 = best outcome). Higher scores indicate better knee functionality. Baseline scores are compared with six-month scores to assess functional improvement.

    Measured: 6 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2022
  2. Study start1 Feb 2023
  3. Primary completion30 Oct 2024
  4. Study completion30 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A study group will be integrated which will be evaluated before the intervention and after 15 days, 3 and 6 subsequent months.
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05450458
Sponsor's protocol ID
CEI/0504/PI/2022
Status last verified
Jul 2025
First submitted
17 Jun 2022
Last updated
22 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Patel DR, Villalobos A. Evaluation and management of knee pain in young athletes: overuse injuries of the knee. Transl Pediatr. 2017 Jul;6(3):190-198. doi: 10.21037/tp.2017.04.05.

    PubMed 28795010

  • Nicolini AP, de Carvalho RT, Matsuda MM, Sayum JF, Cohen M. Common injuries in athletes' knee: experience of a specialized center. Acta Ortop Bras. 2014;22(3):127-31. doi: 10.1590/1413-78522014220300475.

    PubMed 25061417

  • Fuller CW, Ekstrand J, Junge A, Andersen TE, Bahr R, Dvorak J, Hagglund M, McCrory P, Meeuwisse WH. Consensus statement on injury definitions and data collection procedures in studies of football (soccer) injuries. Br J Sports Med. 2006 Mar;40(3):193-201. doi: 10.1136/bjsm.2005.025270.

    PubMed 16505073

  • Majewski M, Susanne H, Klaus S. Epidemiology of athletic knee injuries: A 10-year study. Knee. 2006 Jun;13(3):184-8. doi: 10.1016/j.knee.2006.01.005. Epub 2006 Apr 17.

    PubMed 16603363

  • Wilder RP, Sethi S. Overuse injuries: tendinopathies, stress fractures, compartment syndrome, and shin splints. Clin Sports Med. 2004 Jan;23(1):55-81, vi. doi: 10.1016/S0278-5919(03)00085-1.

    PubMed 15062584

  • Aicale R, Tarantino D, Maffulli N. Overuse injuries in sport: a comprehensive overview. J Orthop Surg Res. 2018 Dec 5;13(1):309. doi: 10.1186/s13018-018-1017-5.

    PubMed 30518382

  • Paoloni M, Bernetti A, Belelli A, Brignoli O, Buoso S, Caputi AP, Catani F, Coclite D, Fini M, Mantovani L, Migliore A, Napoletano A, Viora U, Santilli V. Appropriateness of clinical and organizational criteria for intra-articular injection therapies in osteoarthritis. A Delphi method consensus initiative among experts in Italy. Ann Ist Super Sanita. 2015;51(2):131-8. doi: 10.4415/ANN_15_02_11.

    PubMed 26156184

  • Yang J, Tibbetts AS, Covassin T, Cheng G, Nayar S, Heiden E. Epidemiology of overuse and acute injuries among competitive collegiate athletes. J Athl Train. 2012 Mar-Apr;47(2):198-204. doi: 10.4085/1062-6050-47.2.198.

    PubMed 22488286

  • Drawer S, Fuller CW. Propensity for osteoarthritis and lower limb joint pain in retired professional soccer players. Br J Sports Med. 2001 Dec;35(6):402-8. doi: 10.1136/bjsm.35.6.402.

    PubMed 11726474

  • Vannini F, Spalding T, Andriolo L, Berruto M, Denti M, Espregueira-Mendes J, Menetrey J, Peretti GM, Seil R, Filardo G. Sport and early osteoarthritis: the role of sport in aetiology, progression and treatment of knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2016 Jun;24(6):1786-96. doi: 10.1007/s00167-016-4090-5. Epub 2016 Apr 4.

    PubMed 27043343

  • Frohlich S, Pazeller S, Cherati AS, Muller E, Frey WO, Sporri J. Overuse injuries in the knee, back and hip of top elite female alpine skiers during the off-season preparation period: prevalence, severity and their association with traumatic preinjuries and training load. BMJ Open Sport Exerc Med. 2020 Dec 24;6(1):e000892. doi: 10.1136/bmjsem-2020-000892. eCollection 2020.

    PubMed 33408876

  • Rincon GA, Vyas D, Zhou J, Fu FH, Oiestad BE, Holm I, Aune AK, Gunderson R, Myklebust G, Engebretsen L, Fosdahl M, Risberg MA. "Knee function and prevalence of knee osteoarthritis after anterior cruciate ligament reconstruction: a prospective study with 10 to 15 years of follow-up". Letter to the editor. Am J Sports Med. 2011 Apr;39(4):NP3; author reply NP3-4. doi: 10.1177/0363546511403704. No abstract available.

    PubMed 21460071

  • KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.

    PubMed 13498604

  • Hunter DJ, Lo GH, Gale D, Grainger AJ, Guermazi A, Conaghan PG. The reliability of a new scoring system for knee osteoarthritis MRI and the validity of bone marrow lesion assessment: BLOKS (Boston Leeds Osteoarthritis Knee Score). Ann Rheum Dis. 2008 Feb;67(2):206-11. doi: 10.1136/ard.2006.066183. Epub 2007 May 1.

    PubMed 17472995

  • Maffulli N, Regine R, Carrillo F, Minelli S, Beaconsfield T. Ultrasonographic scan in knee pain in athletes. Br J Sports Med. 1992 Jun;26(2):93-6. doi: 10.1136/bjsm.26.2.93.

    PubMed 1623366

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA in people with Overuse Injury and Body Mass Index in Athletes, run by Hospital Regional Tlalnepantla at 1 site in Mexico.

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 7 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jul 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 Mexico. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: Baseline, 15 days, 3 months, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05450458, which also lists 35 linked publications.

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 22 Jul 2025.

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