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CompletedNCT01805349KhoalaUpdated Mar 31, 2026

Study of Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis

An interventional study of Hand X-rays in Digital Arthrosis, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
479
Allocation
Not applicable
Ages
40 Years to 75 Years
Sex
All
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Study 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).

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Conditions studied

  • Digital Arthrosis
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In context

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • painful hip or knee prosthesis
  • osteotomy in the past
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
479 participants (actual)

Study arms

  • Other
    X-Rays

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

    Radiation: Hand X-rays

Interventions

  • RadiationHand X-rays

    Hand X-rays to assess the digital arthrosis

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What researchers measure

Primary outcomes

  1. Kellgren and Lawrence score

    Kellgren and Lawrence score for hip or knee

    Time frame: Change at 2 years

Secondary outcomes

  1. Harris score

    Time frame: Harris score at 2 years

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Study locations

1 site
  • Department of rheumatology, nice university hospital
    Nice, 06000, France
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References and documents

Publications

  • 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. PubMed 32950705 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01805349
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Mar 6, 2013
Start date
Nov 4, 2013
Primary completion
Dec 1, 2013
Completion
Dec 1, 2013
Last update
Mar 31, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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