Factors Predicting the Duration of Effectiveness of Viscosupplementation in Knee Arthosis

NCT ID: NCT04988698

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-04

Study Completion Date

2023-02-27

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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none intervention

none intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Nord Franche-Comte

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Nord Franche-Comté

Trévenans, , France

Site Status

Countries

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France

References

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Perruchet S, Balblanc JC, Rapp C, Bourgoin C, Guillochon C, Lohse A, Conrozier T. 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. Cartilage. 2023 Jun;14(2):136-143. doi: 10.1177/19476035221109230. Epub 2022 Dec 17.

Reference Type DERIVED
PMID: 36527367 (View on PubMed)

Other Identifiers

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2021-A00773-38

Identifier Type: -

Identifier Source: org_study_id

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