An observational study in Osteoarthritis, Knee, sponsored by Coordinación de Investigación en Salud, Mexico. Not yet recruiting at 1 site in Mexico. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Coordinación de Investigación en Salud, Mexico · Observational
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:
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.
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 160 is above the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Coordinación de Investigación en Salud, Mexico is the lead sponsor of 98 studies on the registry; 16 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Hylan G-F 20
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.
Device: Cross-Linked Sodium Hyaluronate
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.
Also known as: Synvisc
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.
Also known as: Mesoheal
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.
Time frame: Baseline to 6 months after viscosupplementation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through 6 months after viscosupplementation
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Coordinación de Investigación en Salud, Mexico