NCT04988698: PRESAGE

Factors Predicting the Duration of Effectiveness of Viscosupplementation in Knee Arthosis

Completed Last updated 22 June 2023

What this trial tests

trial testing none intervention in Knee Osteoarthritis in 103 participants. Completed in 27 February 2023.

Timeline

4 May 2021

Primary endpoint
27 February 2023

27 February 2023

Quick facts

Lead sponsor	Hopital Nord Franche-Comte
Status	Completed
Study type	OBSERVATIONAL
Enrollment	103
Start date	4 May 2021
Primary completion	27 February 2023
Estimated completion	27 February 2023
Sites	1 location across France

Drugs / interventions tested

• none intervention

Conditions studied

• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

Hopital Nord Franche-Comte

Who can join

18 and older, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Association between Radiographic Features and the Duration of Effectiveness of a Single Injection of Extended-Release Hyaluronic Acid (HANOX-M-XL) in Patients with Knee Osteoarthritis: Preliminary Results of a Prospective Trial.
   Perruchet S, Balblanc JC, Rapp C, Bourgoin C, et al · · 2023 · cited 8× · PMID 36527367 · DOI 10.1177/19476035221109230
2. A Cross-Sectional Study of Factors Predicting the Duration of the Efficacy of Viscosupplementation in Knee Osteoarthritis.
   Rapp C, Boudif F, Bourgoin C, Lohse A, et al · · 2024 · cited 4× · PMID 38610715 · DOI 10.3390/jcm13071949
3. Predictors of Satisfaction in Patients with Knee Osteoarthritis Treated with a Single Injection of Mannitol-Modified Crosslinked Hyaluronate Derivative.
   Balblanc M, Lohse A, Meyer F, Rapp C, et al · · 2024 · cited 1× · PMID 39336860 · DOI 10.3390/jcm13185372
4. Can Certain Antihypertensives Prolong the Efficacy of Hyaluronic Acid Injections in Patients with Osteoarthritis of the Knee? Post Hoc Analysis of a Prospective Observational Trial (PRESAGE).
   Dollinger A, Lohse T, Dolci C, Rapp C, et al · · 2026 · PMID 41827352 · DOI 10.3390/jcm15051935