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Factors Predicting the Duration of Effectiveness of Viscosupplementation in Knee Arthosis

Factors Predicting the Duration of Effectiveness of Viscosupplementation in Knee Arthosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04988698
Acronym
PRESAGE
Enrollment
103
Registered
2021-08-03
Start date
2021-05-04
Completion date
2023-02-27
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

viscosupplementation

Brief summary

Knee osteoarthritis is a frequent condition whose prevalence is estimated at 7.6% of the French population aged 40 to 75, or approximately 2 million individuals . Viscosupplementation (VS) is a symptomatic treatment of knee osteoarthritis recommended by a large number of learned societies. It consists of the intra-articular injection (IA) of hyaluronic acid (HA), to reduce knee pain by restoring normal joint homeostasis impaired by endogenous HA deficiency. The IA administration of HA can be performed using 2 protocols: repeated weekly injections (3, sometimes 5 injections) and single injections. To date and there is no argument to favor either protocol. Regardless of the formula used, the safety of HA is excellent (RR of adverse reaction versus saline = 1.01, 95% CI 0.96-1.07, P = 0.6). The indication for viscosupplementation is the symptomatic treatment of mild to moderate knee osteoarthritis after failure and / or intolerance of analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs). In this indication, after HA injection the responder rate is in the order of 70% to 75% at 6 months and approximately 50% at 12 months. However, the predictors of the duration of effectiveness of SV are still unknown. The objective of the study is to research the factors influencing the duration of the effectiveness of SV, under real life conditions.

Interventions

OTHERnone intervention

none intervention

Sponsors

Hopital Nord Franche-Comte
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All adult outpatients, of both sexes, regardless of age, with a doctor-accepted diagnosis of knee OA and who have been treated with SV within the past 3 years

Exclusion criteria

* Patients who have not been treated with SV in the past 3 years. * Patients who have been treated with VS for an indication other than osteoarthritis of the knee. * Patients in whom the assessment could not be performed reliably

Design outcomes

Primary

MeasureTime frameDescription
Investigate the factors influencing the duration of the effectiveness of SV, under real-life conditionsAt inclusionDuration (in weeks) during which the patient was satisfied with the treatment

Secondary

MeasureTime frameDescription
Research for predictive factors will be carried out on the duration of satisfactionAt inclusionResearch for predictive factors will be carried out on the duration of satisfaction

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026