Osteoarthritis Relationships and Tobacco " Ancillary Study Khoala "

Osteoarthrosis Clinical Trial

Official title:

Osteoarthritis Relationships and Tobacco " Ancillary Study Khoala "

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910830
• Other study ID #: 13-PP-04
• Status: Completed
• Phase: N/A
• First received: September 13, 2016
• Last updated: September 20, 2016
• Start date: September 2014
• Est. completion date: January 2016

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The role of tobacco in osteoarthritis remains controversial. The Khoala cohort is the first multicenter French cohort of subjects with knee and / or hip osteoarthritis prevalent . It guarantees its methodology great representativeness and therefore an interesting material for the study of risk factors in the population. In addition, it should have little here Radiographs of hands for all its patients. It therefore has the opportunity to study a possible relationship between tobacco and hip osteoarthritis , knee and hand but also to study the relationship between tobacco and structural evolution of hip osteoarthritis and / or symptomatic knee.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 848
• Est. completion date: January 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Men or women aged between 40 and 75 years

• hip osteoarthritis and / or knee ( stifle ) , unilateral or bilateral , symptomatic with a confirmed diagnosis and meeting the ACR criteria , representative of prevalent cases in France during the constitution of the cohort

• Affiliation to social security

Exclusion Criteria:

• Presence of a hip or knee prosthesis of the painful joint at baseline ;

• Antecedent osteotomy ;

• severe comorbidity likely to affect significantly the quality of life or induce a major healthcare consumption regardless of osteoarthritis ;

• Knee pain with patellofemoral osteoarthritis isolated , that is to say without tibiofemoral osteoarthritis associated ;

• Other pathologies of these joints

• adults subject to a legal protection measure or unable to express their opposition not to participate in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Joint Diseases
• Osteoarthritis
• Osteoarthrosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relationship between smoking and severity of functional impairment in patients with osteoarthritis of hip and knee osteoarthritis using datas from cohort KOHALA		5 years	No