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

Primary Purpose

Digital Arthrosis

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Hand X-rays

About this trial

This is an interventional basic science trial for Digital Arthrosis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of rheumatology, nice university hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

X-Rays

Arm Description

patients with digital arthrosis and hip/knee arthrosis will practice hand X-rays

Outcomes

Primary Outcome Measures

Kellgren and Lawrence score

Kellgren and Lawrence score for hip or knee

Secondary Outcome Measures

Harris score

Full Information

NCT ID

NCT01805349

First Posted

February 28, 2013

Last Updated

March 5, 2013

Sponsor

Centre Hospitalier Universitaire de Nice

1. Study Identification

Unique Protocol Identification Number

NCT01805349

Brief Title

Study of Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis

Acronym

Khoala

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 Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

March 2013 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Digital Arthrosis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

860 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

X-Rays

Arm Type

Other

Arm Description

patients with digital arthrosis and hip/knee arthrosis will practice hand X-rays

Intervention Type

Radiation

Intervention Name(s)

Hand X-rays

Intervention Description

Hand X-rays to assess the digital arthrosis

Primary Outcome Measure Information:

Title

Kellgren and Lawrence score

Description

Kellgren and Lawrence score for hip or knee

Time Frame

Change at 2 years

Secondary Outcome Measure Information:

Title

Harris score

Time Frame

Harris score at 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian Hubert Roux, MD

roux.cr@chu-nice.fr

Facility Information:

Facility Name

Department of rheumatology, nice university hospital

City

Nice

ZIP/Postal Code

06000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

christian hubert roux, MD

roux.cr@chu-nice.fr

First Name & Middle Initial & Last Name & Degree

Christian Hubert Roux, MD

12. IPD Sharing Statement

Learn more about this trial

Study of Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis

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