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CompletedNCT04988698PRESAGEUpdated Jun 22, 2023

Factors Predicting the Duration of Effectiveness of Viscosupplementation in Knee Arthosis

An observational study in Knee Osteoarthritis, sponsored by Hopital Nord Franche-Comte. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Hopital Nord Franche-Comte · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
103
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Knee Osteoarthritis

Keywords

  • viscosupplementation
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In context

Osteoarthritis

4,397 studies on the registry are indexed under Osteoarthritis; 581 are open to participants now.

This study's enrollment of 103 is close to the median of 100 across 790 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Hopital Nord Franche-Comte is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
103 participants (actual)
Patient registry
No

Interventions

  • Othernone intervention

    none intervention

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What researchers measure

Primary outcomes

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

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

    Time frame: At inclusion

Secondary outcomes

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

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

    Time frame: At inclusion

07

Study locations

1 site
  • Hôpital Nord Franche-Comté
    Trévenans, 90400, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04988698
Lead sponsor
Hopital Nord Franche-Comte
Responsible party
Sponsor
First posted
Aug 3, 2021
Start date
May 4, 2021
Primary completion
Feb 27, 2023
Completion
Feb 27, 2023
Last update
Jun 22, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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