Osteoarthritis, KneeNCT07911696
Comparative Effectiveness and Safety of Two Hyaluronic Acid Products in Knee Osteoarthritis
An observational study of Osteoarthritis, Knee, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
Knee osteoarthritis is a condition that causes pain, stiffness, and difficulty moving the knee. Some people continue to have symptoms despite receiving usual treatments, such as pain medications, exercise, and physical therapy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Hylan G-F 20 and Cross-Linked Sodium Hyaluronate
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 160 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2026to Jun 2027
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients with symptomatic primary knee osteoarthritis, Kellgren-Lawrence grade II or III, receiving care at the Department of Reconstructive Joint Surgery of the Orthopedic Hospital, High Specialty Medical Unit "Dr. Victorio de la Fuente Narváez", Instituto Mexicano del Seguro Social (IMSS), Mexico City, Mexico. Eligible patients who have not responded adequately to conventional pharmacological and non-pharmacological treatments and are considered candidates for intra-articular viscosupplementation will be consecutively invited to participate. Treatment selection will be determined by the treating physician according to routine clinical practice, independently of the research protocol.
Who may be able to join
- Male or female patients older than 18 years.
- Clinical and radiographic evidence of primary knee osteoarthritis according to the American College of Rheumatology criteria, with Kellgren-Lawrence grade II or higher.
- Pain while walking, with a Visual Analog Scale (VAS) score greater than 4.
- Knee pain, stiffness, and functional impairment, with a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score greater than 7.
- Ambulatory patients.
- Candidates for viscosupplementation according to the Mexican Social Security Institute (IMSS) Clinical Practice Guidelines.
Show all 9Show fewer
- Inadequate response to conventional pharmacological and non-pharmacological treatments.
- Ability to quantify nonsteroidal anti-inflammatory drug (NSAID) consumption during follow-up visits by completing a patient diary.
- Ability to provide informed consent independently.
Who cannot join
- Kellgren-Lawrence grade IV patellofemoral or tibiofemoral joint degeneration, or equivalent.
- Significant valgus or varus knee deformities.
- Intra-articular viscosupplementation within the previous 9 months.
- Knee surgery within the previous 6 months.
- Knee instability, ligamentous laxity, or joint locking.
- Concomitant inflammatory joint diseases, including rheumatoid arthritis or psoriatic arthritis.
Show all 10Show fewer
- Systemic or intra-articular corticosteroid use within the previous 3 months.
- Known allergy to hyaluronate or its derivatives.
- Pregnant or breastfeeding women.
- Risk of severe bleeding, including patients receiving anticoagulant therapy without medical supervision.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Henry Martín Quintela Núñez del Prado, MD contact
Mexico1 site
Hospital de Ortopedia, UMAE "Dr. Victorio de la Fuente Narváez", IMSS
Mexico City, Mexico City, 07760
Henry Martín Quintela Núñez del Prado, MD, +52 55 5747 3500 ext. 25300, henry.quintela@imss.gob.mx
About this study
Official title: Comparative Evaluation of the Clinical Effectiveness, Safety, and Cost-Effectiveness of Two Hyaluronic Acid Products for Viscosupplementation in Patients With Knee Osteoarthritis: Real-World Evidence
Knee osteoarthritis is a condition that causes pain, stiffness, and difficulty moving the knee. Some people continue to have symptoms despite receiving usual treatments, such as pain medications, exercise, and physical therapy.
One treatment option is viscosupplementation, which involves injecting a gel-like substance called hyaluronic acid into the knee joint. Different products are available, but it is not clear whether they provide similar benefits, have similar side effects, or differ in cost.
Read more
The goal of this study is to compare two hyaluronic acid products, Mesoheal and Synvisc, in adults with knee osteoarthritis. The researchers want to find out:
- How well each product reduces knee pain.
- How much each product improves knee movement and daily activities.
- What side effects may occur.
- How the costs of the two treatments compare with their benefits.
The study will include approximately 160 adults who need viscosupplementation as part of their usual medical care. Each person's doctor will choose the treatment based on their medical needs and routine clinical practice. The researchers will not assign treatments.
Participants will be followed for six months. During this time, researchers will assess changes in pain, knee function, and any side effects that may occur.
The results may help doctors and healthcare providers better understand the benefits, safety, and costs of these treatments in routine clinical care.
Read the detailed description
Background and Rationale
Knee osteoarthritis is a chronic degenerative joint disease associated with pain, stiffness, functional impairment, and reduced quality of life. Intra-articular hyaluronic acid viscosupplementation is used in patients who experience inadequate symptom control with conventional pharmacological and non-pharmacological treatments. However, comparative evidence regarding the effectiveness, safety, and cost-effectiveness of different hyaluronic acid formulations under routine clinical conditions remains limited.
Study Objective
This study aims to compare the clinical effectiveness, safety, and cost-effectiveness of non-animal-derived cross-linked sodium hyaluronate (Mesoheal) and hylan G-F 20 (Synvisc) in adults with symptomatic knee osteoarthritis receiving viscosupplementation as part of routine medical care.
Study Design
This is a single-center, prospective, analytical, observational cohort study conducted at the Orthopedic Hospital of the High Specialty Medical Unit "Dr. Victorio de la Fuente Narváez", Instituto Mexicano del Seguro Social (IMSS), Mexico City, Mexico.
Approximately 160 participants will be enrolled in two parallel cohorts according to the viscosupplementation product received. Treatment selection will be determined exclusively by the treating physician based on clinical judgment, existing treatment guidelines, and product availability. No randomization or treatment assignment by the investigators will occur.
Clinical Assessment and Follow-up
Participants will be followed for six months after viscosupplementation. Clinical effectiveness will be assessed through changes in pain intensity, knee-related disability, functional status, and articular cartilage integrity. Standardized clinical assessment tools and magnetic resonance imaging will be used according to the study protocol.
Treatment safety will be evaluated by recording adverse events, including their frequency, severity, and seriousness.
Statistical Analysis
Descriptive and comparative analyses will be conducted to evaluate differences between cohorts. Multivariable regression models will be used to account for potential confounding factors, including age, sex, comorbidities, previous treatments, and baseline anthropometric measurements.
Economic Evaluation
A cost-effectiveness analysis will be performed from the public healthcare provider's perspective over a six-month period. Direct medical costs related to viscosupplementation, healthcare utilization, adverse event management, and rescue medication will be considered. Incremental cost-effectiveness ratios will be calculated to compare the economic outcomes of both products.
Study Relevance
This study will provide real-world evidence on the comparative clinical and economic outcomes of Mesoheal and Synvisc. The findings may inform clinical decision-making and healthcare resource allocation for knee osteoarthritis treatment within the Mexican Social Security Institute.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Hylan G-F 20, Cross-Linked Sodium Hyaluronate
- Keywords
- Cost-Benefit Analysis, Hyaluronic Acid, Hylan G-F 20, Mesoheal, Osteoarthritis, Knee, Real-World Evidence, Synvisc, Treatment Outcome, Viscosupplementation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hylan G-F 20Device
Also called Synvisc
Hylan G-F 20 (Synvisc) is a sterile, cross-linked hyaluronan preparation of avian origin supplied in prefilled 2 mL syringes at a concentration of 8 mg/mL. It is administered by intra-articular injection into the knee according to the approved product instructions and routine clinical practice. Treatment selection and administration are determined by the treating physician independently of the research protocol.
Cross-Linked Sodium HyaluronateDevice
Also called Mesoheal
Mesoheal is a sterile, non-animal-derived, cross-linked sodium hyaluronate preparation supplied in a prefilled 2.5 mL syringe containing 25 mg of sodium hyaluronate. It is administered by intra-articular injection into the knee according to the product instructions and routine clinical practice. Treatment selection and administration are determined by the treating physician independently of the research protocol.
| Study group | Role | What they receive |
|---|---|---|
| Hylan G-F 20 (Synvisc) | Patients with knee osteoarthritis receiving intra-articular viscosupplementation with hylan G-F 20 (Synvisc) as part of routine clinical care. The treating physician selects the product independently of the research protocol. Approximately 80 participants are expected in this cohort and will be followed for six months to evaluate clinical effectiveness and safety. Receives: Device: Hylan G-F 20 | |
| Cross-Linked Sodium Hyaluronate (Mesoheal) | Patients with knee osteoarthritis receiving intra-articular viscosupplementation with non-animal-derived cross-linked sodium hyaluronate (Mesoheal) as part of routine clinical care. The treating physician selects the product independently of the research protocol. Approximately 80 participants are expected in this cohort and will be followed for six months to evaluate clinical effectiveness and safety. Receives: Device: Cross-Linked Sodium Hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving Treatment Response at 6 Months
Treatment response will be defined as an improvement of at least 20% from baseline in at least two of four effectiveness measures: knee pain assessed using the Visual Analog Scale (VAS), knee-related disability assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), functional status assessed using the MSH1 scale, and articular cartilage integrity assessed by magnetic resonance imaging (MRI) T2 mapping. The outcome will be reported as the percentage of participants meeting the treatment response criteria in each cohort at six months.
Measured: Baseline to 6 months after viscosupplementation
Secondary outcomes (7)
Change in Knee Pain Intensity Assessed by the Visual Analog Scale (VAS)
Knee pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Changes from baseline will be evaluated at 2, 4, and 6 months after viscosupplementation.
Measured: Baseline and 2, 4, and 6 months after viscosupplementation
Change in Knee Osteoarthritis Symptoms Assessed by the WOMAC Index
Knee osteoarthritis symptoms will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The questionnaire consists of 24 items covering pain (5 items), stiffness (2 items), and physical function (17 items). Each item is scored from 0 (no symptoms) to 4 (extreme symptoms), resulting in a total score ranging from 0 to 96. Higher scores indicate greater symptom severity and functional impairment. Changes in the total WOMAC score from baseline will be evaluated at 2, 4, and 6 months after viscosupplementation.
Measured: Baseline and 2, 4, and 6 months after viscosupplementation
Change in Knee Functional Status Assessed by the MSH1 Scale
Knee functional status will be assessed using the MSH1 scale, a clinical assessment instrument comprising 10 items that evaluate mobility, walking ability, stair climbing, chair use, knee instability, pain, range of motion, extension limitation, flexion limitation, and knee alignment. The total score ranges from 0 to 70 points, with higher scores indicating better clinical and functional status. Changes in total MSH1 scores from baseline to six months after viscosupplementation will be compared between cohorts.
Measured: Baseline and 6 months after viscosupplementation
Change in Articular Cartilage T2 Relaxation Time Assessed by Magnetic Resonance Imaging
Articular cartilage composition will be assessed using magnetic resonance imaging (MRI) T2 mapping with CartiGram software. T2 relaxation times, expressed in milliseconds (ms), provide quantitative information related to cartilage collagen matrix organization and water content. Changes in T2 relaxation time from baseline to six months after viscosupplementation will be evaluated and compared between cohorts. This outcome assesses structural and compositional cartilage changes independently of clinical symptom improvement.
Measured: Baseline and 6 months after viscosupplementation
Proportion of Participants Experiencing at Least One Adverse Event
Safety will be assessed by recording adverse events following intra-articular viscosupplementation, including local pain, swelling, redness, inflammatory reactions, allergic reactions, infections, and systemic symptoms. Adverse events will be classified by intensity (mild, moderate, or severe) and seriousness (serious or non-serious). The outcome will be reported as the number and percentage of participants experiencing at least one adverse event in each cohort, regardless of its causal relationship with the treatment.
Measured: From viscosupplementation administration through 6 months of follow-up
Change in Analgesic Consumption During Follow-up
Analgesic consumption will be assessed using patient-reported medication diaries documenting the use of pain-relieving medications, including nonsteroidal anti-inflammatory drugs (NSAIDs), during follow-up. Changes in medication use after viscosupplementation will be evaluated and compared between the Mesoheal and Synvisc cohorts.
Measured: Baseline and 2, 4, and 6 months after viscosupplementation
Incremental Cost-Effectiveness Ratio of Mesoheal Compared With Synvisc
The incremental cost-effectiveness ratio (ICER) will be calculated from the public healthcare provider perspective over six months. Direct medical costs will include viscosupplementation products, intra-articular administration, unscheduled consultations, emergency care, adverse event management, and rescue analgesics. Effectiveness will be defined as an improvement of at least 20% from baseline in at least two of four measures: VAS, WOMAC, MSH1, and MRI T2 cartilage assessment. The ICER will be calculated as the difference in mean costs per patient divided by the difference in treatment response proportions between the Mesoheal and Synvisc cohorts. Results will be expressed in Mexican pesos (MXN) per additional treatment responder.
Measured: Baseline through 6 months after viscosupplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- Ortopedia Ana S.A. de C.V.
- Responsible party
- Sponsor
- Investigators
- Henry Martín Quintela Núñez del Prado, MD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911696
- Sponsor's protocol ID
- R-2026-785-044
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with external researchers because the study does not include an approved data-sharing plan. Participant confidentiality will be protected in accordance with the informed consent and institutional policies of the Mexican Social Security Institute (IMSS). Study findings will be disseminated through scientific publications and reports using aggregated data that do not identify individual participants.
Publications
Thomas T, Amouroux F, Vincent P. Intra articular hyaluronic acid in the management of knee osteoarthritis: Pharmaco-economic study from the perspective of the national health insurance system. PLoS One. 2017 Mar 22;12(3):e0173683. doi: 10.1371/journal.pone.0173683. eCollection 2017.
PubMed 28328935Rosen J, Niazi F, Dysart S. Cost-Effectiveness of Treating Early to Moderate Stage Knee Osteoarthritis with Intra-articular Hyaluronic Acid Compared to Conservative Interventions. Adv Ther. 2020 Jan;37(1):344-352. doi: 10.1007/s12325-019-01142-x. Epub 2019 Nov 18.
PubMed 31735982Ong KL, Farr J, Gudeman AS, Murray IR, McIntyre LF, Hummer CD, Ngai W, Lau E, Altman RD, Sherman SL. Risk of Severe Acute Localized Reactions for Different Intraarticular Hyaluronic Acid Knee Injections in a Real-World Setting. Cartilage. 2021 Dec;13(1_suppl):376S-386S. doi: 10.1177/19476035211025815. Epub 2021 Sep 13.
PubMed 34515539Pelletier JP, Raynauld JP, Abram F, Dorais M, Delorme P, Martel-Pelletier J. Exploring determinants predicting response to intra-articular hyaluronic acid treatment in symptomatic knee osteoarthritis: 9-year follow-up data from the Osteoarthritis Initiative. Arthritis Res Ther. 2018 Mar 1;20(1):40. doi: 10.1186/s13075-018-1538-7.
PubMed 29490683Raman R, Dutta A, Day N, Sharma HK, Shaw CJ, Johnson GV. Efficacy of Hylan G-F 20 and Sodium Hyaluronate in the treatment of osteoarthritis of the knee -- a prospective randomized clinical trial. Knee. 2008 Aug;15(4):318-24. doi: 10.1016/j.knee.2008.02.012. Epub 2008 Apr 21.
PubMed 18430574
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Clinical Effectiveness, Safety, and Cost-Effectiveness of Two Hyaluronic Acid Products for Viscosupplementation in Patients With Knee Osteoarthritis: Real-World Evidence
- ClinicalTrials.gov ID
- NCT07911696
- Acronym / sponsor ID
- R-2026-785-044
- Conditions
- Osteoarthritis, Knee
- Keywords
- Cost-Benefit Analysis, Hyaluronic Acid, Hylan G-F 20, Mesoheal, Osteoarthritis, Knee, Real-World Evidence, Synvisc, Treatment Outcome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- Ortopedia Ana S.A. de C.V.
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Nov 2026 (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.
Knee osteoarthritis is a condition that causes pain, stiffness, and difficulty moving the knee. Some people continue to have symptoms despite receiving usual treatments, such as pain medications, exercise, and physical therapy.
One treatment option is viscosupplementation, which involves injecting a gel-like substance called hyaluronic acid into the knee joint. Different products are available, but it is not clear whether they provide similar benefits, have similar side effects, or differ in cost.
The goal of this study is to compare two hyaluronic acid products, Mesoheal and Synvisc, in adults with knee osteoarthritis. The researchers want to find out:
- How well each product reduces knee pain.
- How much each product improves knee movement and daily activities.
- What side effects may occur.
- How the costs of the two treatments compare with their benefits.
The study will include approximately 160 adults who need viscosupplementation as part of their usual medical care. Each person's doctor will choose the treatment based on their medical needs and routine clinical practice. The researchers will not assign treatments.
Participants will be followed for six months. During this time, researchers will assess changes in pain, knee function, and any side effects that may occur.
The results may help doctors and healthcare providers better understand the benefits, safety, and costs of these treatments in routine clinical care.
Detailed description
Background and Rationale
Knee osteoarthritis is a chronic degenerative joint disease associated with pain, stiffness, functional impairment, and reduced quality of life. Intra-articular hyaluronic acid viscosupplementation is used in patients who experience inadequate symptom control with conventional pharmacological and non-pharmacological treatments. However, comparative evidence regarding the effectiveness, safety, and cost-effectiveness of different hyaluronic acid formulations under routine clinical conditions remains limited.
Study Objective
This study aims to compare the clinical effectiveness, safety, and cost-effectiveness of non-animal-derived cross-linked sodium hyaluronate (Mesoheal) and hylan G-F 20 (Synvisc) in adults with symptomatic knee osteoarthritis receiving viscosupplementation as part of routine medical care.
Study Design
This is a single-center, prospective, analytical, observational cohort study conducted at the Orthopedic Hospital of the High Specialty Medical Unit "Dr. Victorio de la Fuente Narváez", Instituto Mexicano del Seguro Social (IMSS), Mexico City, Mexico.
Approximately 160 participants will be enrolled in two parallel cohorts according to the viscosupplementation product received. Treatment selection will be determined exclusively by the treating physician based on clinical judgment, existing treatment guidelines, and product availability. No randomization or treatment assignment by the investigators will occur.
Clinical Assessment and Follow-up
Participants will be followed for six months after viscosupplementation. Clinical effectiveness will be assessed through changes in pain intensity, knee-related disability, functional status, and articular cartilage integrity. Standardized clinical assessment tools and magnetic resonance imaging will be used according to the study protocol.
Treatment safety will be evaluated by recording adverse events, including their frequency, severity, and seriousness.
Statistical Analysis
Descriptive and comparative analyses will be conducted to evaluate differences between cohorts. Multivariable regression models will be used to account for potential confounding factors, including age, sex, comorbidities, previous treatments, and baseline anthropometric measurements.
Economic Evaluation
A cost-effectiveness analysis will be performed from the public healthcare provider's perspective over a six-month period. Direct medical costs related to viscosupplementation, healthcare utilization, adverse event management, and rescue medication will be considered. Incremental cost-effectiveness ratios will be calculated to compare the economic outcomes of both products.
Study Relevance
This study will provide real-world evidence on the comparative clinical and economic outcomes of Mesoheal and Synvisc. The findings may inform clinical decision-making and healthcare resource allocation for knee osteoarthritis treatment within the Mexican Social Security Institute.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hylan G-F 20 (Synvisc) | – | Device: Hylan G-F 20Patients with knee osteoarthritis receiving intra-articular viscosupplementation with hylan G-F 20 (Synvisc) as part of routine clinical care. The treating physician selects the product independently of the research protocol. Approximately 80 participants are expected in this cohort and will be followed for six months to evaluate clinical effectiveness and safety. |
| Cross-Linked Sodium Hyaluronate (Mesoheal) | – | Device: Cross-Linked Sodium HyaluronatePatients with knee osteoarthritis receiving intra-articular viscosupplementation with non-animal-derived cross-linked sodium hyaluronate (Mesoheal) as part of routine clinical care. The treating physician selects the product independently of the research protocol. Approximately 80 participants are expected in this cohort and will be followed for six months to evaluate clinical effectiveness and safety. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients with symptomatic primary knee osteoarthritis, Kellgren-Lawrence grade II or III, receiving care at the Department of Reconstructive Joint Surgery of the Orthopedic Hospital, High Specialty Medical Unit "Dr. Victorio de la Fuente Narváez", Instituto Mexicano del Seguro Social (IMSS), Mexico City, Mexico. Eligible patients who have not responded adequately to conventional pharmacological and non-pharmacological treatments and are considered candidates for intra-articular viscosupplementation will be consecutively invited to participate. Treatment selection will be determined by the treating physician according to routine clinical practice, independently of the research protocol.
Key inclusion criteria (9 listed)
- Male or female patients older than 18 years.
- Clinical and radiographic evidence of primary knee osteoarthritis according to the American College of Rheumatology criteria, with Kellgren-Lawrence grade II or higher.
- Pain while walking, with a Visual Analog Scale (VAS) score greater than 4.
- Knee pain, stiffness, and functional impairment, with a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score greater than 7.
- Ambulatory patients.
Key exclusion criteria (10 listed)
- Kellgren-Lawrence grade IV patellofemoral or tibiofemoral joint degeneration, or equivalent.
- Significant valgus or varus knee deformities.
- Intra-articular viscosupplementation within the previous 9 months.
- Knee surgery within the previous 6 months.
- Knee instability, ligamentous laxity, or joint locking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hylan G-F 20Also: SynviscHylan G-F 20 (Synvisc) is a sterile, cross-linked hyaluronan preparation of avian origin supplied in prefilled 2 mL syringes at a concentration of 8 mg/mL. It is administered by intra-articular injection into the knee according to the approved product instructions and routine clinical practice. Treatment selection and administration are determined by the treating physician independently of the research protocol. | Device | Hylan G-F 20 (Synvisc) |
| Cross-Linked Sodium HyaluronateAlso: MesohealMesoheal is a sterile, non-animal-derived, cross-linked sodium hyaluronate preparation supplied in a prefilled 2.5 mL syringe containing 25 mg of sodium hyaluronate. It is administered by intra-articular injection into the knee according to the product instructions and routine clinical practice. Treatment selection and administration are determined by the treating physician independently of the research protocol. | Device | Cross-Linked Sodium Hyaluronate (Mesoheal) |
Primary outcome
Proportion of Participants Achieving Treatment Response at 6 Months
Time frame: Baseline to 6 months after viscosupplementation
Treatment response will be defined as an improvement of at least 20% from baseline in at least two of four effectiveness measures: knee pain assessed using the Visual Analog Scale (VAS), knee-related disability assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), functional status assessed using the MSH1 scale, and articular cartilage integrity assessed by magnetic resonance imaging (MRI) T2 mapping. The outcome will be reported as the percentage of participants meeting the treatment response criteria in each cohort at six months.
7 secondary outcomes
Change in Knee Pain Intensity Assessed by the Visual Analog Scale (VAS)
Time frame: Baseline and 2, 4, and 6 months after viscosupplementation
Change in Knee Osteoarthritis Symptoms Assessed by the WOMAC Index
Time frame: Baseline and 2, 4, and 6 months after viscosupplementation
Change in Knee Functional Status Assessed by the MSH1 Scale
Time frame: Baseline and 6 months after viscosupplementation
Change in Articular Cartilage T2 Relaxation Time Assessed by Magnetic Resonance Imaging
Time frame: Baseline and 6 months after viscosupplementation
Proportion of Participants Experiencing at Least One Adverse Event
Time frame: From viscosupplementation administration through 6 months of follow-up
Change in Analgesic Consumption During Follow-up
Time frame: Baseline and 2, 4, and 6 months after viscosupplementation
Incremental Cost-Effectiveness Ratio of Mesoheal Compared With Synvisc
Time frame: Baseline through 6 months after viscosupplementation
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 3 Nov 2026.
- Background: PubMed 28328935Thomas T, Amouroux F, Vincent P. Intra articular hyaluronic acid in the management of knee osteoarthritis: Pharmaco-economic study from the perspective of the national health insurance system. PLoS One. 2017 Mar 22;12(3):e0173683. doi: 10.1371/journal.pone.0173683. eCollection 2017.
- Background: PubMed 31735982Rosen J, Niazi F, Dysart S. Cost-Effectiveness of Treating Early to Moderate Stage Knee Osteoarthritis with Intra-articular Hyaluronic Acid Compared to Conservative Interventions. Adv Ther. 2020 Jan;37(1):344-352. doi: 10.1007/s12325-019-01142-x. Epub 2019 Nov 18.
- Background: PubMed 34515539Ong KL, Farr J, Gudeman AS, Murray IR, McIntyre LF, Hummer CD, Ngai W, Lau E, Altman RD, Sherman SL. Risk of Severe Acute Localized Reactions for Different Intraarticular Hyaluronic Acid Knee Injections in a Real-World Setting. Cartilage. 2021 Dec;13(1_suppl):376S-386S. doi: 10.1177/19476035211025815. Epub 2021 Sep 13.
- Background: PubMed 29490683Pelletier JP, Raynauld JP, Abram F, Dorais M, Delorme P, Martel-Pelletier J. Exploring determinants predicting response to intra-articular hyaluronic acid treatment in symptomatic knee osteoarthritis: 9-year follow-up data from the Osteoarthritis Initiative. Arthritis Res Ther. 2018 Mar 1;20(1):40. doi: 10.1186/s13075-018-1538-7.
- Background: PubMed 18430574Raman R, Dutta A, Day N, Sharma HK, Shaw CJ, Johnson GV. Efficacy of Hylan G-F 20 and Sodium Hyaluronate in the treatment of osteoarthritis of the knee -- a prospective randomized clinical trial. Knee. 2008 Aug;15(4):318-24. doi: 10.1016/j.knee.2008.02.012. Epub 2008 Apr 21.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with external researchers because the study does not include an approved data-sharing plan. Participant confidentiality will be protected in accordance with the informed consent and institutional policies of the Mexican Social Security Institute (IMSS). Study findings will be disseminated through scientific publications and reports using aggregated data that do not identify individual participants.
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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.
Henry Martín Quintela Núñez del Prado, MD contact
Henry Martín Quintela Núñez del Prado, MD principal investigator
Instituto Mexicano del Seguro Social
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 Coordinación de Investigación en Salud, Mexico 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 9 inclusion and 10 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 3 Nov 2026. 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.
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 Henry Martín Quintela Núñez del Prado, MD (+52 55 5747 3500 ext. 25300, henry.quintela@imss.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving Treatment Response at 6 Months (time frame: Baseline to 6 months after viscosupplementation). 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 NCT07911696, which also lists 5 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 3 Nov 2026.