Skip to main content
OpenTrials
Completed

NCT Number: NCT02887092

Determinants of Functional Ability, Perceived Health, and Interaction With Multimorbidity in Hip and Knee Osteoarthritis

Hip and knee osteoarthritis (OA) is an important health problem with a high prevalence and significant consequences on functional ability, perceived health, restriction of autonomy and handicap. The weight of multimorbidities and their interaction on functional ability and perceived health are left unexplored. This project will rely on the cohort KHOALA, representative, multiregional, of 881 prevalent cases (symptomatic hip and knee OA).

Main objective:

* to describe the evolution over time of pain, functional ability, social participation and quality of life in subjects with hip and knee OA * to identify prognosis factors of disease evolution (socio-demographic, clinical, and other health parameters) * to determine interactions with comorbidities, other personal and environmental factors (ICF model).

Concurrent objective: to improve measurement of perceived health specific to hip and knee OA by the OAKHQOL by improving its metrologic performances based on item response theory.

Task 1: To prepare an improved measurement scale, available as a judgment criteria for the 3rd year of cohort follow up, over the april 2010-march 2012 period, the mini-OAKHQOL Task 2: Evaluation of the cohort in 2010-2012 (year 3 of follow up) in a repeated measure design to best assess the evolution of perceived health and functional ability over time, and to identify stability of deterioration of autonomy. Perspectives: This project targets to provide public health deciders with information of good quality to help them manage determinants of perceived health in OA subjects, as essential factors to health care resource utilization in their various modalities.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hip or knee osteoarthritis (tibiofemoral), uni or bilateral, symptomatic, with confirmed diagnosis according to American College of Rheumatology ACR and European League Against Rheumatism (EULAR)
  • Kellgren and Laurence radiological stage at least 2

Exclusion criteria

  • knee or hip prosthesis on painful joint
  • preceding osteotomy
  • serious comorbidity (affecting quality of life, or leading to a high care consumption)
  • according to X-ray : knee pain with isolated patello-femoral osteoarthritis (i.e without an associated tibiofemoral osteoarthritis)
  • other pathology on knee or hip
  • adults getting a legal protection or with the incapacity to give their consent

Treatment and study plan

Primary outcomes

  1. change in quality of life

    Time frame: 3 years

Secondary outcomes

  1. comorbidity

    Time frame: 3 years

    Functional comorbidity index

  2. change in functional ability

    Time frame: 3 years

    Womac score

  3. change in pain

    Time frame: 3 years

    VAS

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • University of Lorraine
  • University of Paris 5 - Rene Descartes

Registry information

Official study title

Determinants of Functional Ability and Perceived Health, and Interaction With Multimorbidity in Hip and Knee Osteoarthritis

Acronym: PRO-ART

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Sep 1, 2016
Registry last updated
Sep 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.