Digital ArthrosisKhoalaNCT01805349
Study of Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis
A study testing Hand X-rays in people with Digital Arthrosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Digital Arthrosis
- What is being tested?
- Hand X-rays
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 479 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2013to 1 Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- painful hip or knee prosthesis
- osteotomy in the past
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Digital Arthrosis
- Being tested
- Hand X-rays
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand X-raysRadiation
Hand X-rays to assess the digital arthrosis
| Study group | Role | What they receive |
|---|---|---|
| X-Rays | Other | patients with digital arthrosis and hip/knee arthrosis will practice hand X-rays Receives: Radiation: Hand X-rays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kellgren and Lawrence score
Kellgren and Lawrence score for hip or knee
Measured: Change at 2 years
Secondary outcomes (1)
Harris score
Measured: Harris score at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study start4 Nov 2013
- Primary completion1 Dec 2013
- Study completion1 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Digital ArthrosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805349
- Sponsor's protocol ID
- 12-AOI-01
- Acronym
- Khoala
- Status last verified
- Mar 2026
- First submitted
- 28 Feb 2013
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01805349
- Acronym / sponsor ID
- Khoala / 12-AOI-01
- Conditions
- Digital Arthrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 4 Nov 2013 (actual)
- Primary completion
- 1 Dec 2013 (actual)
- Study completion
- 1 Dec 2013 (actual)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| X-Rays | Other | Radiation: Hand X-rayspatients with digital arthrosis and hip/knee arthrosis will practice hand X-rays |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- painful hip or knee prosthesis
- osteotomy in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand X-raysHand X-rays to assess the digital arthrosis | Radiation | X-Rays |
Primary outcome
Kellgren and Lawrence score
Time frame: Change at 2 years
Kellgren and Lawrence score for hip or knee
1 secondary outcome
Harris score
Time frame: Harris score at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Results publication: PubMed 32950705Roux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand X-rays in people with Digital Arthrosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kellgren and Lawrence score (time frame: Change at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01805349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.