Skip to main content
OpenTrials
Completed

NCT Number: NCT04988698

Factors Predicting the Duration of Effectiveness of Viscosupplementation in Knee Arthosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Nord Franche-Comté

Trévenans, 90400, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

None intervention

Other

none intervention

Primary outcomes

  1. Investigate the factors influencing the duration of the effectiveness of SV, under real-life conditions

    Time frame: At inclusion

    Duration (in weeks) during which the patient was satisfied with the treatment

Secondary outcomes

  1. Research for predictive factors will be carried out on the duration of satisfaction

    Time frame: At inclusion

    Research for predictive factors will be carried out on the duration of satisfaction

Sponsors and collaborators

Lead sponsor

Hopital Nord Franche-Comte

Other

Registry information

Acronym: PRESAGE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2021
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.