Study of Association Between Digital Osteoarthritis and L... | NCT01805349

Studies
Study of Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis

NCT01805349

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Mar 31, 2026Actual

Enrollment

479Actual

Phase

Not Applicable

Conditions

Digital Arthrosis

Interventions

Hand X-rays

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 4, 2013Actual

Primary Completion Date

Dec 1, 2013Actual

Completion Date

Dec 1, 2013Actual

First Submitted Date

Feb 28, 2013

First Submission Date that Met QC Criteria

Mar 5, 2013

First Posted Date

Mar 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2026

Last Update Posted Date

Mar 31, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

479Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
X-Rays	Other	patients with digital arthrosis and hip/knee arthrosis will practice hand X-rays	Radiation: Hand X-rays

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hand X-rays	Radiation	Hand X-rays to assess the digital arthrosis	X-Rays

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Kellgren and Lawrence score	Kellgren and Lawrence score for hip or knee	Change at 2 years

Secondary Outcomes

Measure	Description	Time Frame
Harris score		Harris score at 2 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of rheumatology, nice university hospital		Nice		06000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32950705	Result	Roux CH, Coste J, Roger C, Fontas E, Rat AC, Guillemin F. Impact of smoking on femorotibial and hip osteoarthritis progression: 3-year follow-up data from the KHOALA cohort. Joint Bone Spine. 2021 Mar;88(2):105077. doi: 10.1016/j.jbspin.2020.09.009. Epub 2020 Sep 17.