Hip OsteoarthritisKHOALANCT00481338
Prevalence,Natural History,Prognosis Factor,QualityofLife,Health Care Consumption and Social Consequences of Symptomatic Knee and Hip Osteoarthritis in France
A study testing X-rays, biological samples and medical information about osteoarthritis in people with Hip Osteoarthritis and Knee Osteoarthritis, run by Central Hospital, Nancy, France at 6 sites in France.
Trial summary
The aim of the project is to assemble and to follow on a 10-year period a nationwide representative sample of lower limb OA patients. General objectives: To document the natural history and to identify predictive factors of the evolution and consequences of hip and knee OA in terms of pain, functional disability… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hip Osteoarthritis, Knee Osteoarthritis
- What is being tested?
- X-rays, biological samples and medical information about osteoarthritis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 878 participants
- Where
- 6 sitesFrance
- Study dates
- Apr 2007to Mar 2019
- 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
- male and female aged between 40 and 75 years
- symptomatic hip or knee, uni or bilateral OA with clinical diagnosis confirmed by a medical physician and satisfying ACR classification criteria
- Representative of prevalent cases in France at the cohort set-up time
Who cannot join
- presence of hip or knee joint replacement surgery
- comorbidities severe enough to affect quality of life significantly or likely to induce a high health care consumption independently of OA
- an history of osteotomy
- Patello-femoral osteoarthritis without tibio-femoral osteoarthritis
- Other joint diseases of the target joints
- adult under legal protection or not able to consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Patrice Fardellone
Amiens
CHU de la Cavale Blanche
Brest, 29609
CHU Nancy, hopital brabois
Nancy, 54035
CHU l'Archet
Nice, 06202
Hôpital de la Pitié-Salpêtrière
Paris, 75651
CHU Rangueil
Toulouse, 31059
About this study
Official title: Knee and Hip OsteoArthritis Long Term Assessment. Prevalence, Natural History, Prognosis Factor, Quality of Life, Health Care Consumption and Social Consequences of Symptomatic Knee and Hip Osteoarthritis in France
The aim of the project is to assemble and to follow on a 10-year period a nationwide representative sample of lower limb OA patients.
General objectives: To document the natural history and to identify predictive factors of the evolution and consequences of hip and knee OA in terms of pain, functional disability, structural damage, quality of life, autonomy, medical and health care use and cost of disease.
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Being tested
- X-rays, biological samples, medical information about osteoarthritis
- Keywords
- Cohort, Quality of life, Health resource use, Disability, Prognosis
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-raysProcedure or surgery
X-rays (hip and knee) every 2 years
biological samplesBiological
biological sample (blood and urine) every 2 years
medical information about osteoarthritisOther
several questionnaires about pain and function (WOMAC), physical activity (MAQ), quality of life (generic SF-36 and OA specific OAKHQOL/AMIQUAL), comorbidities (FCI), mental status (MMS), heath status (GHQ 28) and health resource consumption
| Study group | Role | What they receive |
|---|---|---|
| Study specific procedure | Experimental | X-rays, biological samples and medical information about osteoarthritis Receives: Procedure: X-rays; Biological: biological samples; Other: medical information about osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life, patient reported outcome measures
Measured: every year, up to 10 years
Secondary outcomes (1)
health care consumption
Measured: every year, up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 878 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis Guillemin, MD, PhD, Principal investigator, CHU Nancy (promoteur)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481338
- Sponsor's protocol ID
- DGS2006-0146
- Acronym
- KHOALA
- Status last verified
- Jul 2015
- First submitted
- 31 May 2007
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Garnero P, Guillemin F, Ngueyon Sime W, Gineyts E, Chapurlat R, Roux C. Cartilage turnover, but not novel synovial collagen marker, is associated with joint damage progression in osteoarthritis patients. Rheumatology (Oxford). 2026 Jan 8;65(1):keaf510. doi: 10.1093/rheumatology/keaf510.
PubMed 41002273Rat AC, Sellam J, Mazieres B, Ngueyon Sime W, Fardellone P, Guillemin F. Body composition is associated with changes in health-related quality of life in patients with knee and/or hip osteoarthritis. RMD Open. 2025 Jan 2;11(1):e004733. doi: 10.1136/rmdopen-2024-004733.
PubMed 39753295
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee and Hip OsteoArthritis Long Term Assessment. Prevalence, Natural History, Prognosis Factor, Quality of Life, Health Care Consumption and Social Consequences of Symptomatic Knee and Hip Osteoarthritis in France
- ClinicalTrials.gov ID
- NCT00481338
- Acronym / sponsor ID
- KHOALA / DGS2006-0146
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Keywords
- Cohort, Quality of life, Health resource use, Disability, Prognosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 878 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 1 Jun 2007 (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.
The aim of the project is to assemble and to follow on a 10-year period a nationwide representative sample of lower limb OA patients.
General objectives: To document the natural history and to identify predictive factors of the evolution and consequences of hip and knee OA in terms of pain, functional disability, structural damage, quality of life, autonomy, medical and health care use and cost of disease.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study specific procedure | Experimental | Procedure: X-rays, Biological: biological samples, Other: medical information about osteoarthritisX-rays, biological samples and medical information about osteoarthritis |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male and female aged between 40 and 75 years
- symptomatic hip or knee, uni or bilateral OA with clinical diagnosis confirmed by a medical physician and satisfying ACR classification criteria
- Representative of prevalent cases in France at the cohort set-up time
Key exclusion criteria (6 listed)
- presence of hip or knee joint replacement surgery
- comorbidities severe enough to affect quality of life significantly or likely to induce a high health care consumption independently of OA
- an history of osteotomy
- Patello-femoral osteoarthritis without tibio-femoral osteoarthritis
- Other joint diseases of the target joints
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 |
|---|---|---|
| X-raysX-rays (hip and knee) every 2 years | Procedure or surgery | Study specific procedure |
| biological samplesbiological sample (blood and urine) every 2 years | Biological | Study specific procedure |
| medical information about osteoarthritisseveral questionnaires about pain and function (WOMAC), physical activity (MAQ), quality of life (generic SF-36 and OA specific OAKHQOL/AMIQUAL), comorbidities (FCI), mental status (MMS), heath status (GHQ 28) and health resource consumption | Other | Study specific procedure |
Primary outcome
Quality of life, patient reported outcome measures
Time frame: every year, up to 10 years
1 secondary outcome
health care consumption
Time frame: every year, up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
- Derived from this study: PubMed 41002273Garnero P, Guillemin F, Ngueyon Sime W, Gineyts E, Chapurlat R, Roux C. Cartilage turnover, but not novel synovial collagen marker, is associated with joint damage progression in osteoarthritis patients. Rheumatology (Oxford). 2026 Jan 8;65(1):keaf510. doi: 10.1093/rheumatology/keaf510.
- Derived from this study: PubMed 39753295Rat AC, Sellam J, Mazieres B, Ngueyon Sime W, Fardellone P, Guillemin F. Body composition is associated with changes in health-related quality of life in patients with knee and/or hip osteoarthritis. RMD Open. 2025 Jan 2;11(1):e004733. doi: 10.1136/rmdopen-2024-004733.
Related trials for Hip Osteoarthritis
Active, not recruiting
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
Francis Guillemin, MD, PhD principal investigator
CHU Nancy (promoteur)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X-rays, biological samples and medical information about osteoarthritis in people with Hip Osteoarthritis and Knee Osteoarthritis, run by Central Hospital, Nancy, France at 6 sites 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 6 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: status not confirmed, as of the sponsor's last update on 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Results are not available in the source record.
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?
Quality of life, patient reported outcome measures (time frame: every year, up to 10 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 NCT00481338, which also lists 2 linked publications.
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 3 Aug 2015.