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Study of Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis (Khoala)

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ClinicalTrials.gov Identifier: NCT01805349
Recruitment Status : Unknown
Verified March 2013 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Not yet recruiting
First Posted : March 6, 2013
Last Update Posted : March 6, 2013
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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Brief Summary:
Among the risk factors for lower limb osteoarthritis, if obesity is probably the most studied, digital osteoarthritis received increasing interest in recent years. Recent publications have highlighted a link between obesity and digital osteoarthritis, but also a very probable link between digital osteoarthritis and structural progression of knee osteoarthritis. Few data including hip exist and need to be confirmed on larger scale studies. We have with "Khoala" a national multiregional cohort of symptomatic gonarthrosis and coxarthrosis representative of the general population (which is rarely the case in the literature) including X ray, clinical and biological follow-up (hips and / or knees).

Condition or disease Intervention/treatment Phase
Digital Arthrosis Radiation: Hand X-rays Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 860 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of the Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis (Knee and Hip) in Terms of Severity and Evolution - Khoala Group Ancillary Project / Cohort Khoala
Study Start Date : March 2013
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arms and Interventions
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Arm Intervention/treatment
X-Rays
patients with digital arthrosis and hip/knee arthrosis will practice hand X-rays
 Radiation: Hand X-rays
Hand X-rays to assess the digital arthrosis


Outcome Measures
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Primary Outcome Measures :
  1. Kellgren and Lawrence score [ Time Frame: Change at 2 years ]
    Kellgren and Lawrence score for hip or knee


Secondary Outcome Measures :
  1. Harris score [ Time Frame: Harris score at 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men or women aged 40 to 75 years
  • with symptomatic osteoarthritis of the hip and / or knee (femoro-tibial), unilateral or bilateral
  • with a confirmed diagnosis (criteria of the American College of Rheumatology :ACR) and Kellgren and Lawrence radiological stage ≥ 2.

Exclusion Criteria:

  • painful hip or knee prosthesis
  • osteotomy in the past
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805349


Contacts
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Contact: Christian Hubert Roux, MD roux.cr@chu-nice.fr

Locations
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France
Department of rheumatology, nice university hospital
Nice, France, 06000
Contact: christian hubert roux, MD       roux.cr@chu-nice.fr   
Principal Investigator: Christian Hubert Roux, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01805349    
Other Study ID Numbers: 12-AOI-01
First Posted: March 6, 2013    Key Record Dates
Last Update Posted: March 6, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases