Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-29 @ 7:32 PM
Study NCT ID:
NCT06141928
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2023-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-19', 'studyFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2023-11-19', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional recovery after total hip arthroplasty / Range of motion', 'timeFrame': '2 years', 'description': 'Investigators analyze active and passive range of motion (ROM) measured in degrees.'}, {'measure': 'Functional recovery after total hip arthroplasty / Walking speed', 'timeFrame': '2 years', 'description': 'Investigators analyze walking speed in seconds for the 50 meters long walk.'}, {'measure': 'Functional recovery after total hip arthroplasty / Harris Hip Score', 'timeFrame': '2 years', 'description': 'Investigators take a questionnaire (Harris Hip Score, HHS), the maximum point is 100.'}, {'measure': 'Functional recovery after total hip arthroplasty / Hip abductors strength', 'timeFrame': '2 years', 'description': 'Investigators analyze hip abductors strength measured with a dynamometer in kilograms (kg).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Hip Arthroplasty', 'Functional Recovery']}, 'descriptionModule': {'briefSummary': 'This study aimed to determine differences in functional recovery after total hip arthroplasty between a group of patients operated on using a direct lateral approach, an anterolateral minimally invasive approach, and a posterior approach to the hip joint.\n\nArthroplasty is the most commonly performed surgical procedure in orthopedics and is also considered the gold standard for treating the final stage of osteoarthritis. There are several different approaches, but there are still conflicting studies that talk about the benefits of a particular approach. There is an insufficient number of scientific, prospective studies that monitor the basic functional and rehabilitation parameters, which are also indicators of the success of the performed procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hip osteoarthritis\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT06141928', 'briefTitle': 'Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Clinic for Orthopedics Lovran'}, 'officialTitle': 'Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'Clinic OL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Functional Recovery', 'interventionNames': ['Other: Functional recovery analysis']}], 'interventions': [{'name': 'Functional recovery analysis', 'type': 'OTHER', 'description': 'Functional recovery analysis with force evaluator \\& tester', 'armGroupLabels': ['Functional Recovery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51145', 'city': 'Lovran', 'state': 'Primorje-Gorski Kotar County', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Tomislav Prpic, PhD, MD', 'role': 'CONTACT', 'email': 'tomislav.prpic317@gmail.com', 'phone': '+38598461143'}, {'name': 'Antea Buterin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sandra Spanja Prpic, mag.physiotherap.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mirela Vuckovic, mag.physiotherap.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tomislav Prpic, PhD, MD, Assist. Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinic for Orthopeadics and Traumatology Lovran', 'geoPoint': {'lat': 45.29194, 'lon': 14.27417}}], 'centralContacts': [{'name': 'Antea Buterin, MD', 'role': 'CONTACT', 'email': 'antea.buterin@yahoo.com', 'phone': '+385191978453'}], 'overallOfficials': [{'name': 'Antea Buterin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic OL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinic for Orthopedics Lovran', 'class': 'OTHER'}, 'collaborators': [{'name': 'Special Hospital for Orthopedics Biograd na Moru', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department', 'investigatorFullName': 'Antea Buterin', 'investigatorAffiliation': 'Clinic for Orthopedics Lovran'}}}}