Factors Predicting the Duration of Effectiveness of Viscosupplementation in Knee Arthosis

NCT04988698 | Completed

• 1 other identifier: 2021-A00773-38
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

viscosupplementation

Outcome Measures

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

  At inclusion

Secondary Outcomes (1)

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

  At inclusion

Interventions

none intervention OTHER

none intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Nord Franche-Comte: lead

Study Sites (1)

Hôpital Nord Franche-Comté

Trévenans, 90400, France

Location

Related Publications (1)

• 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.

  PMID: 36527367 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 3, 2021
• Study Start: May 4, 2021
• Primary Completion: February 27, 2023
• Study Completion: February 27, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

FR (1)