Trial · NCT07911696
Comparative Effectiveness and Safety of Two Hyaluronic Acid Products in Knee Osteoarthritis
NCT07911696, Not yet recruiting, Coordinación de Investigación en Salud, Mexico
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Comparative Effectiveness and Safety of Two Hyaluronic Acid Products in Knee Osteoarthritis. Trials, record NCT07911696. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07911696
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Effectiveness and Safety of Two Hyaluronic Acid Products in Knee Osteoarthritis
- NCT number
- NCT07911696
- Status
- Not yet recruiting
- Enrollment
- 160 participants, estimated
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Conditions
- Osteoarthritis, Knee
- Interventions
- Hylan G-F 20, Cross-Linked Sodium Hyaluronate
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Achieving Treatment Response at 6 Months | 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. |
| Secondary | Change in Knee Pain Intensity Assessed by the Visual Analog Scale (VAS) | Baseline and 2, 4, and 6 months after viscosupplementation | 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. |
| Secondary | Change in Knee Osteoarthritis Symptoms Assessed by the WOMAC Index | Baseline and 2, 4, and 6 months after viscosupplementation | 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. |
| Secondary | Change in Knee Functional Status Assessed by the MSH1 Scale | Baseline and 6 months after viscosupplementation | 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. |
| Secondary | Change in Articular Cartilage T2 Relaxation Time Assessed by Magnetic Resonance Imaging | Baseline and 6 months after viscosupplementation | 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. |
| Secondary | Proportion of Participants Experiencing at Least One Adverse Event | From viscosupplementation administration through 6 months of follow-up | 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. |
| Secondary | Change in Analgesic Consumption During Follow-up | Baseline and 2, 4, and 6 months after viscosupplementation | 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. |
| Secondary | Incremental Cost-Effectiveness Ratio of Mesoheal Compared With Synvisc | Baseline through 6 months after viscosupplementation | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07911696
GET https://conductscience.org/api/trials/v1/NCT07911696/registered