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

Osteoarthritis Clinical Trial

— PRO-ART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887092
• Other study ID #: PRO-ART
• Status: Completed
• Phase: N/A
• First received: August 25, 2016
• Last updated: August 29, 2016
• Start date: April 2007
• Est. completion date: March 2011

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 881
• Est. completion date: March 2011
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Paris Descartes University, University of Lorraine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in quality of life		3 years	No
Secondary	comorbidity	Functional comorbidity index	3 years	No
Secondary	change in functional ability	Womac score	3 years	No
Secondary	change in pain	VAS	3 years	No