NCT02879890

Brief Summary

National cohort study aimed to investigate the impact of comorbidities (number and type of comorbidities) on health utility state change in lower lim osteoarthritis (hip and knee OA).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
878

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

5 years

First QC Date

August 23, 2016

Last Update Submit

August 25, 2016

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Change in health utility state

    Change in health state utility score between the inclusion in the KHOALA cohort and 5 years later (T5-T0)

    Five years

Secondary Outcomes (1)

  • Minimal Clinically Important Difference (MCID) of health utility state

    Five years

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Population-based

You may qualify if:

  • age: 40-75 years
  • Uni or bilateral lower limb osteoarthritis (OA) according to the American College of Rheumatology (ACR) and European league against rheumatism (EULAR) criteria

You may not qualify if:

  • Hip or knee prothesis
  • Antecedent of osteotomy
  • Severe comorbidity
  • Adult under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Francis GUILLEMIN, MD, PhD

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 26, 2016

Study Start

March 1, 2009

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 26, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Open to partnership