Factors Predicting the Duration of Effectiveness of Viscosupplementation in Knee Arthosis

Knee Osteoarthritis Clinical Trial

— PRESAGE  

Official title:

Factors Predicting the Duration of Effectiveness of Viscosupplementation in Knee Arthosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04988698
• Other study ID #: 2021-A00773-38
• Status: Completed
• Start date: May 4, 2021
• Est. completion date: February 27, 2023

Study information

• Verified date: June 2023
• Source: Hopital Nord Franche-Comte
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 27, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• none intervention
none intervention

Locations

Country	Name	City	State
France	Hôpital Nord Franche-Comté	Trévenans

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Nord Franche-Comte

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At inclusion
Secondary	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	At inclusion