Hip OsteoarthritisNCT02042586
Evaluation of Locomotor Activity Before and After Total Hip Replacement in Patients With Hip Osteoarthritis.
An observational study of Hip Osteoarthritis and Indication for Total Hip Replacement, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The investigators believe that the application of non-linear methods of analysis using the ganglion and neural network technique will make it possible to analyse all of the complex data obtained in patients with hip osteoarthritis before and then after total hip replacement, and should allow us to identify a… Read more about this study
- Who is it for?
- Ages 25 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis, Indication for Total Hip Replacement
- What is being tested?
- Analysis of movement before total hip replacement and Analysis of movement after total hip replacement
- How many people
- 202 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2010to 11 Dec 2014
- Phase
- Observational
- 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 25 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: hip osteoarthritis indication for total hip replacement
Who may be able to join
- Control group:
- Subjects who have provided written informed consent
- Subjects covered by the national health insurance scheme
- Men or women aged between 25 and 85 years
- able to understand simple instructions and packaging instructions and able to give informed consent
- Patients group:
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- Patients who have provided written informed consent
- Patients covered by the national health insurance scheme
- Men or women aged between 25 and 85 years
- able to understand simple instructions and packaging instructions and to give their informed consent
- Suffering from hip osteoarthritis defined according to ACR criteria
- Most recent radiography examination less than 6 months earlier
- Radiological stage II, III or IV hip osteoarthritis according to the Kellgren and Lawrence classification
- Presenting with an indication for total hip replacement, according to the surgeon's usual criteria
Who cannot join
- Control group:
- Hip osteoarthritis or other arthrosis in the lower limbs
- Pregnant or breast-feeding women
- Disorders that may interfere with gait analysis
- Disorder that may be destabilized by gait analysis
- Neurological disease and/or motor neuron disease
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- Patients group:
- Contra-indication for total hip replacement
- Repeat surgery for total hip replacement
- Impossibility to use a standard implant
- Pregnant or breast-feeding women
- Inflammatory flare of the hip osteoarthritis
- Disorder that may interfere with gait analysis
- Disorder that may be destabilized by gait analysis
- Rapidly destructive hip osteoarthritis
- Neurological disease and/or motor neuron disease
- Hip dysplasia requiring THR to be completed using a graft
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Locomotor Activity Before and After Total Hip Replacement in Patients With Hip Osteoarthritis. Use of Ganglion and Neural Network Techniques to Identify Objective Criteria for the Success of Arthroplasty
The investigators believe that the application of non-linear methods of analysis using the ganglion and neural network technique will make it possible to analyse all of the complex data obtained in patients with hip osteoarthritis before and then after total hip replacement, and should allow us to identify a combination of objective variables to classify the surgery as " successful " or " unsuccessful ".
To this end, the study will take place as follows:
Step 1: Screening, and inclusion. Step 2: Evaluation of the hip osteoarthritis and analysis of locomotor activity Step 3: Total hip replacement Step 4: Clinical evaluation of locomotor activity carried out between 6 months and 1 year after the THR Step 5: Data analysis
- Being tested
- Analysis of movement before total hip replacement, Analysis of movement after total hip replacement
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of movement before total hip replacementOther
Analysis of movement after total hip replacementOther
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: Analysis of movement before total hip replacement; Other: Analysis of movement after total hip replacement | |
| Controls | Not described Receives: Other: Analysis of movement before total hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of patient statisfaction
Measured: Before and between 6 months and 1 year after total hip replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study start7 Jan 2010
- Primary completion11 Dec 2014
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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
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
- NCT02042586
- Sponsor's protocol ID
- TROUILLOUD AOI 2007
- Status last verified
- May 2019
- First submitted
- 17 Jan 2014
- Last updated
- 3 May 2019
- Results posted
- No
Publications
Riglet L, Bourredjem A, Laroche D, Benguella L, Binquet C, Maillefert JF, Ornetti P, Gueugnon M. Hip disability and Osteoarthritis Outcome Score trajectories and prognostic factors for functional decline: A 3-year follow-up study. Ann Phys Rehabil Med. 2025 Feb;68(1):101893. doi: 10.1016/j.rehab.2024.101893. Epub 2024 Dec 9.
PubMed 39657458Moissenet 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 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Locomotor Activity Before and After Total Hip Replacement in Patients With Hip Osteoarthritis. Use of Ganglion and Neural Network Techniques to Identify Objective Criteria for the Success of Arthroplasty
- ClinicalTrials.gov ID
- NCT02042586
- Acronym / sponsor ID
- TROUILLOUD AOI 2007
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 7 Jan 2010 (actual)
- Primary completion
- 11 Dec 2014 (actual)
- First posted
- 23 Jan 2014 (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 investigators believe that the application of non-linear methods of analysis using the ganglion and neural network technique will make it possible to analyse all of the complex data obtained in patients with hip osteoarthritis before and then after total hip replacement, and should allow us to identify a combination of objective variables to classify the surgery as " successful " or " unsuccessful ".
To this end, the study will take place as follows:
Step 1: Screening, and inclusion. Step 2: Evaluation of the hip osteoarthritis and analysis of locomotor activity Step 3: Total hip replacement Step 4: Clinical evaluation of locomotor activity carried out between 6 months and 1 year after the THR Step 5: Data analysis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Analysis of movement before total hip replacement, Other: Analysis of movement after total hip replacement |
| Controls | – | Other: Analysis of movement before total hip replacement |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- hip osteoarthritis indication for total hip replacement
Key inclusion criteria (14 listed)
- Subjects who have provided written informed consent
- Subjects covered by the national health insurance scheme
- Men or women aged between 25 and 85 years
- able to understand simple instructions and packaging instructions and able to give informed consent
- Patients who have provided written informed consent
Key exclusion criteria (17 listed)
- Hip osteoarthritis or other arthrosis in the lower limbs
- Pregnant or breast-feeding women
- Disorders that may interfere with gait analysis
- Disorder that may be destabilized by gait analysis
- Neurological disease and/or motor neuron disease
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 |
|---|---|---|
| Analysis of movement before total hip replacement | Other | Controls, Patients |
| Analysis of movement after total hip replacement | Other | Patients |
Primary outcome
Degree of patient statisfaction
Time frame: Before and between 6 months and 1 year after total hip replacement
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 3 May 2019.
- Derived from this study: PubMed 39657458Riglet L, Bourredjem A, Laroche D, Benguella L, Binquet C, Maillefert JF, Ornetti P, Gueugnon M. Hip disability and Osteoarthritis Outcome Score trajectories and prognostic factors for functional decline: A 3-year follow-up study. Ann Phys Rehabil Med. 2025 Feb;68(1):101893. doi: 10.1016/j.rehab.2024.101893. Epub 2024 Dec 9.
- 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.
Related trials for 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
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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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?
An observational study of Hip Osteoarthritis and Indication for Total Hip Replacement, 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 14 inclusion and 17 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 3 May 2019. 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?
Degree of patient statisfaction (time frame: Before and between 6 months and 1 year after total hip replacement). 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 NCT02042586, 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 May 2019.