Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT04170218
Brief Summary:
Introduction: Hip and knee osteoarthritis (OA) was ranked in 2010 as the eleventh highest contributor to global disability. In France in 2014, non-spinal OA was the leading self-reported cause of morbidity among adults over sixty-five years of age, with a prevalence of 49.5 per cent. OA is known to be the first cause of disability in activities of daily life and a risk factor of frailty among people over seventy-five years of age. Despite its major impact on the elderly population's quality of life and health, quality of care for OA in elderly patients remains understudied.
Objective: The study aims to assess the quality of care for knee and hip OA in patients aged 75 years and over.
Detailed Description:
Method: This prospective multicentric observational cohort study enrolls participants of 75 years and over with symptomatic hip or knee OA for more than three months, hospitalized in seven geriatric departments of three hospitals of "Assistance Publique - Hôpitaux de Paris", for any cause of admission. Quality of care for OA before hospitalization is assessed by the Assessing Care of Vulnerable Elderly's (ACOVE) quality indicators (QI) for OA, using a questionnaire. The primary endpoint is the pass rate for the ACOVE's QI about referral to an orthopedic surgeon for patients with severe functionally compromising knee or hip OA. The secondary endpoints are the pass rates for the six others ACOVE's QI for OA (annual assessment of functional status and degree of pain ; exercise therapy for patients with newly diagnosed knee OA ; education regarding the natural history, treatment, and self- management of OA ; acetaminophen as first-line pharmacologic therapy ; advising patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) of their risks ; offering prophylaxis with a proton-pump inhibitor or misoprostol to patients treated with non-selective NSAIDs) and other elements of hip or knee OA care not assessed by the seven QI (including use of opioid analgesics, NSAIDs, intra-articular infiltrations, joint replacements). The sample is described with a rheumatologic assessment including Western Ontario and MACmaster universities osteoarthritis index (WOMAC) and Kellgren-Laurence classification, and with a geriatric assessment including nutritional status, Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) scores, Mini Mental State Examination (MMSE) score, Timed Up and Go walking test, modified Short Emergency Geriatric Assessment (mSEGA) scale and Cumulative Illness Rating Scale for Geriatrics (CIRS-G). Participants also complete the 12-Item Short Form Survey version 2 (SF-12v2) quality of life questionnaire. They receive a call twelve months after inclusion to collect vital status, orthopedic consultation and joint replacement during the last year.
Study:
NCT04170218
Study Brief:
Protocol Section:
NCT04170218