Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-01-01 @ 9:25 PM
Study NCT ID:
NCT01907503
Status:
UNKNOWN
Last Update Posted:
2013-07-25
First Post:
2013-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptation of Locomotor Activity in Patients Suffering From Hip OA - Analysis of This Adaptation as a Prognostic Criterion for Future Disease Progression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-24', 'studyFirstSubmitDate': '2013-07-17', 'studyFirstSubmitQcDate': '2013-07-24', 'lastUpdatePostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'locomotor activity', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Hip Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '40597862', 'type': 'DERIVED', 'citation': 'Yang 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.'}, {'pmid': '32039174', 'type': 'DERIVED', 'citation': 'Moissenet 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.'}]}, 'descriptionModule': {'briefSummary': 'To assess the prognostic value of a characteristic evaluation of gait in persons suffering from hip OA for subsequent indications for THR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.\n\nSpine 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.)"}, 'identificationModule': {'nctId': 'NCT01907503', 'briefTitle': 'Adaptation of Locomotor Activity in Patients Suffering From Hip OA - Analysis of This Adaptation as a Prognostic Criterion for Future Disease Progression', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'orgStudyIdInfo': {'id': 'Maillefert PHRC R 2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with Primary hip osteoarthritis', 'description': 'Patients with Primary hip osteoarthritis', 'interventionNames': ['Procedure: Evaluation of the balance of force platform']}, {'type': 'OTHER', 'label': 'Healthy volunteer', 'description': 'Healthy volunteer', 'interventionNames': ['Procedure: Evaluation of the balance of force platform']}], 'interventions': [{'name': 'Evaluation of the balance of force platform', 'type': 'PROCEDURE', 'armGroupLabels': ['Healthy volunteer', 'Patients with Primary hip osteoarthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maud CARPENTIER', 'role': 'CONTACT', 'email': 'maud.carpentier@chu-dijon.fr', 'phone': '03.80.29.35.10'}, {'name': 'Jean-francis Maillefert', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}