Primary Hip OsteoarthritisNCT01907503
Adaptation of Locomotor Activity in Patients Suffering From Hip OA - Analysis of This Adaptation as a Prognostic Criterion for Future Disease Progression
A study testing Evaluation of the balance of force platform in people with Primary Hip Osteoarthritis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
To assess the prognostic value of a characteristic evaluation of gait in persons suffering from hip OA for subsequent indications for THR. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Hip Osteoarthritis
- What is being tested?
- Evaluation of the balance of force platform
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2008to 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women aged between 45 and 75 years Suffering from primary hip osteoarthritis defined according to ACR criteria who presented pain in the hip for at least one month in the preceding 3 months Radiological stage II, III or IV hip OA according to the Kellgren and Lawrence classification Patients able to understand simple instructions des packaging instructions, to give their written informed consent.
Who cannot join
- Indication for THR at the time of inclusion. Pregnant or breast-feeding women Alzheimer's disease Chronic respiratory insufficiency with clinical manifestations Parkinson's disease Motor neuron disease Major musculo-skeletal disorder (other than hip OA) Severe non-stabilised diabetes Non-stabilised hypertension Hip OA inflammation flare Rapidly-destructive hip OA Radiography to evaluate structural evolution of the disease done more than 12 months previously Presence of OA in another joint, or another osteoarticular or periarticular disease of the lower limbs with, in the opinion of the patient, disability due to this other disease that is greater than the disability caused by the hip OA.
- Spine disease causing gait disturbance (radiculalgia, lumbar canal stenosis,… with, in the opinion of the patient, disability due to this other disease that is greater than the disability caused by the hip OA.)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Dijon
Dijon, 21079
Maud CARPENTIER, 03.80.29.35.10, maud.carpentier@chu-dijon.fr
Jean-francis Maillefert
About this study
To assess the prognostic value of a characteristic evaluation of gait in persons suffering from hip OA for subsequent indications for THR.
- Conditions
- Primary Hip Osteoarthritis
- Being tested
- Evaluation of the balance of force platform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the balance of force platformProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with Primary hip osteoarthritis | Other | Patients with Primary hip osteoarthritis Receives: Procedure: Evaluation of the balance of force platform |
| Healthy volunteer | Other | Healthy volunteer Receives: Procedure: Evaluation of the balance of force platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
locomotor activity
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startFeb 2008
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907503
- Sponsor's protocol ID
- Maillefert PHRC R 2004
- Status last verified
- Jul 2013
- First submitted
- 17 Jul 2013
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Mangalam M, Schlattmann B, Deans C, Wellsandt E. Network analysis reveals that total hip arthroplasty restores shared segmental motion before segmental differentiation. Front Netw Physiol. 2026 Oct 7;6:1916345. doi: 10.3389/fnetp.2026.1916345. eCollection 2026.
PubMed 42908682Yang Q, Ji X, Zhang Y, Du S, Ji B, Zeng W. An interpretable machine learning approach for predicting and grading hip osteoarthritis using gait analysis. BMC Musculoskelet Disord. 2025 Jul 1;26(1):580. doi: 10.1186/s12891-025-08911-6.
PubMed 40597862Moissenet F, Naaim A, Ornetti P, Bourredjem A, Binquet C, Morisset C, Gouteron A, Maillefert JF, Laroche D. Is the Pelvis-Thorax Coordination a Valuable Outcome Instrument to Assess Patients With Hip Osteoarthritis? Front Bioeng Biotechnol. 2020 Jan 23;7:457. doi: 10.3389/fbioe.2019.00457. eCollection 2019.
PubMed 32039174
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of Locomotor Activity in Patients Suffering From Hip OA - Analysis of This Adaptation as a Prognostic Criterion for Future Disease Progression
- ClinicalTrials.gov ID
- NCT01907503
- Acronym / sponsor ID
- Maillefert PHRC R 2004
- Conditions
- Primary Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2013 (estimated)
- First posted
- 25 Jul 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.
To assess the prognostic value of a characteristic evaluation of gait in persons suffering from hip OA for subsequent indications for THR.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Primary hip osteoarthritis | Other | Procedure: Evaluation of the balance of force platformPatients with Primary hip osteoarthritis |
| Healthy volunteer | Other | Procedure: Evaluation of the balance of force platformHealthy volunteer |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men or women aged between 45 and 75 years Suffering from primary hip osteoarthritis defined according to ACR criteria who presented pain in the hip for at least one month in the preceding 3 months Radiological stage II, III or IV hip OA according to the Kellgren and Lawrence classification Patients able to understand simple instructions des packaging instructions, to give their written informed consent.
Key exclusion criteria (2 listed)
- Indication for THR at the time of inclusion. Pregnant or breast-feeding women Alzheimer's disease Chronic respiratory insufficiency with clinical manifestations Parkinson's disease Motor neuron disease Major musculo-skeletal disorder (other than hip OA) Severe non-stabilised diabetes Non-stabilised hypertension Hip OA inflammation flare Rapidly-destructive hip OA Radiography to evaluate structural evolution of the disease done more than 12 months previously Presence of OA in another joint, or another osteoarticular or periarticular disease of the lower limbs with, in the opinion of the patient, disability due to this other disease that is greater than the disability caused by the hip OA.
- Spine disease causing gait disturbance (radiculalgia, lumbar canal stenosis,… with, in the opinion of the patient, disability due to this other disease that is greater than the disability caused by the hip OA.)
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 |
|---|---|---|
| Evaluation of the balance of force platform | Procedure or surgery | Healthy volunteer, Patients with Primary hip osteoarthritis |
Primary outcome
locomotor activity
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
- Derived from this study: PubMed 42908682Mangalam M, Schlattmann B, Deans C, Wellsandt E. Network analysis reveals that total hip arthroplasty restores shared segmental motion before segmental differentiation. Front Netw Physiol. 2026 Oct 7;6:1916345. doi: 10.3389/fnetp.2026.1916345. eCollection 2026.
- Derived from this study: PubMed 40597862Yang Q, Ji X, Zhang Y, Du S, Ji B, Zeng W. An interpretable machine learning approach for predicting and grading hip osteoarthritis using gait analysis. BMC Musculoskelet Disord. 2025 Jul 1;26(1):580. doi: 10.1186/s12891-025-08911-6.
- Derived from this study: PubMed 32039174Moissenet F, Naaim A, Ornetti P, Bourredjem A, Binquet C, Morisset C, Gouteron A, Maillefert JF, Laroche D. Is the Pelvis-Thorax Coordination a Valuable Outcome Instrument to Assess Patients With Hip Osteoarthritis? Front Bioeng Biotechnol. 2020 Jan 23;7:457. doi: 10.3389/fbioe.2019.00457. eCollection 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of the balance of force platform in people with Primary Hip Osteoarthritis, run by Centre Hospitalier Universitaire Dijon 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 1 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: status not confirmed, as of the sponsor's last update on 25 Jul 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
locomotor activity (time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks). 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 NCT01907503, which also lists 3 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 25 Jul 2013.