Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 10:02 PM
Study NCT ID:
NCT05763368
Status:
WITHDRAWN
Last Update Posted:
2023-05-25
First Post:
2022-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Proprioception in Patients With Total Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'lack of participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2022-07-14', 'studyFirstSubmitQcDate': '2023-02-28', 'lastUpdatePostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline postural stability and proprioception', 'timeFrame': 'At baseline, 3 months, 6 months, and 12 months from surgery', 'description': 'Improvement of stability, evaluated with Berg Balance Scale, 0=minimum (the worst), 56 = maximum (the best)'}, {'measure': 'Change from baseline postural stability and proprioception', 'timeFrame': 'At baseline, 3 months, 6 months, and 12 months from surgery', 'description': 'Improvement of stability and proprioception, evaluated with Delos Proprioceptive System'}], 'secondaryOutcomes': [{'measure': 'Clinical improvements', 'timeFrame': 'At baseline, 3 months, 6 months, and 12 months from surgery', 'description': 'Evaluation of clinical improvements using the Harris Hip Score, 0=minimum (the worst), 100 = maximum (the best)'}, {'measure': 'Clinical improvements', 'timeFrame': 'At baseline, 3 months, 6 months, and 12 months from surgery', 'description': 'Evaluation of clinical improvements using the Patient Reported Outcome Measures with HOOS (Hip disability and Osteoarthritis Outcome Score) Physical Function shortform (HOOS-PS), 0=minimum (the worst), 100 = maximum (the best)'}, {'measure': 'Patient satisfaction', 'timeFrame': 'At baseline, 3 months, 6 months, and 12 months from surgery', 'description': 'Evaluation of patient satisfaction using the 12-Item Short Form Health Survey (SF-12) 0=minimum (the worst), 100 = maximum (the best)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coxarthrosis; Primary']}, 'descriptionModule': {'briefSummary': 'Disturbances of balance and postural stability are frequent in patients with coxarthrosis due to the damage to the mechanoreceptors, characteristic of arthritic degeneration, and muscular hypotrophy of the affected limb.\n\nThe aim of the study is to evaluate with adequate instrumentation the alterations of proprioception and postural control in patients with hip osteoarthrosis and the effectiveness of joint reconstruction in improving any deficit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary Osteoarthrosis\n* BMI \\< 35 kg/m\\^2\n* Able to stand in monopodalic support without aids / support\n\nExclusion Criteria:\n\n* History of previous hip or knee replacement\n* Orthopedic trauma within the previous 6 months\n* Pathologies that can interfere with balance: neurological (of the central nervous system, neuropathies, movement disorders), vestibular, visual, cognitive disability, consumption of alcohol / drugs / psychoactive drugs in the 24 hours prior to the test'}, 'identificationModule': {'nctId': 'NCT05763368', 'acronym': 'PROPRIO-ATA', 'briefTitle': 'Evaluation of Proprioception in Patients With Total Hip Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Evaluation of Proprioception in Patients With Total Hip Replacement', 'orgStudyIdInfo': {'id': '0004373'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Minimally Invasive Lateral Approach', 'interventionNames': ['Diagnostic Test: Clinical tests and proprioception evaluation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Anterior Approach', 'interventionNames': ['Diagnostic Test: Clinical tests and proprioception evaluation']}], 'interventions': [{'name': 'Clinical tests and proprioception evaluation', 'type': 'DIAGNOSTIC_TEST', 'description': "Each patient will be evaluated using clinical scales (BBS, HHS, HOOS, SF12) and ''Delos Proprioceptive System'' to assess postural stability and proprioception.", 'armGroupLabels': ['Anterior Approach', 'Minimally Invasive Lateral Approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'IRCCS-Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rehabilitation Unit Head', 'investigatorFullName': 'Mariagrazia Benedetti', 'investigatorAffiliation': 'Istituto Ortopedico Rizzoli'}}}}