Factors Predicting the Duration of Effectiveness of Viscosupplementation in Knee Arthosis (PRESAGE)

June 20, 2023 updated by: Hopital Nord Franche-Comte

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Trévenans, France, 90400
        • Hôpital Nord Franche-Comté

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

A questionnaire is administered by the investigator during the medical consultation. No act is performed outside of patient care.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Nord Franche-Comte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2021

Primary Completion (Actual)

February 27, 2023

Study Completion (Actual)

February 27, 2023

Study Registration Dates

First Submitted

July 15, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A00773-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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