NCT02887092

Completed

Determinants of Functional Ability, Perceived Health, and In...

Central Hospital, Nancy, France Source

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Other study identifiers

Sponsor study identifier

PRO-ART

Study Type

observational

Actual enrollment (reported)

881

Locations

0 countries

Sites

N/A

Timeline

Study Start

April 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2009

Actual (reported)

Study Completion

March 2011

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 881 participants
Study completion date: March 2011
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2007
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
March 2009
Actual (reported)
Study Completion
March 2011
Actual (reported)
First Submitted
August 25, 2016
Actual (reported)
First Posted
September 1, 2016
Actual (reported)

Last Updated: September 1, 2016
Status Verified: August 2016
Last Update Submitted: August 29, 2016

Conditions

Osteoarthritis

Keywords

health determinantsepidemiologymaintaining autonomypsychologyosteoarthritisperceived health

Outcome Measures

Primary Outcomes (1)

change in quality of life
3 years

Secondary Outcomes (3)

comorbidity
3 years
change in functional ability
3 years
change in pain
3 years

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

patient with hip or knee osteoarthritis

You may qualify if:

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)

Sponsors & Collaborators

Central Hospital, Nancy, France
Otherlead
University of Paris 5 - Rene Descartes
Othercollaborator
University of Lorraine

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

Francis Guillemin, MD, PhD
CHRU Nancy
PRINCIPAL INVESTIGATOR

Enrollment

881 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: professor

Study Record Dates

First Submitted

August 25, 2016

First Posted

September 1, 2016

Study Start

April 2007

Date type not reported

This date has not been verified as actual or estimated.

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Kellgren and Laurence radiological stage at least 2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Othercollaborator

Primary Completion

March 2009

Actual (reported)

Study Completion

March 2011

Actual (reported)

Last Updated

September 1, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing: Will share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT02887092
Data provider: ClinicalTrials.gov
Source updated: 2016-09-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:17 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record