Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT04791605
Status:
COMPLETED
Last Update Posted:
2021-03-10
First Post:
2021-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gait Pattern Between a Cemented and Non-cemented Femur Stem
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077107', 'term': 'Gait Analysis'}], 'ancestors': [{'id': 'D005684', 'term': 'Gait'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000076604', 'term': 'Physical Functional Performance'}, {'id': 'D010809', 'term': 'Physical Fitness'}, {'id': 'D006262', 'term': 'Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Cemented femur stem Non-cemented femur stem'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Gait of cemented femur stem of acute cervical collum femoris stem. Gait of non-cemented femur stem of acute cervical collum femoris stem.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2021-03-04', 'studyFirstSubmitQcDate': '2021-03-08', 'lastUpdatePostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait Analysis with focus on hip kinematics 2 year after total hip arthroplasty', 'timeFrame': '2 year postop', 'description': 'Optical tracking system focusing on reflective markers according a model used in gait analysis in order to record degrees of hip angels in 3 planes'}, {'measure': 'Gait Analysis with focus on hip kinetics 2 year after total hip arthroplasty', 'timeFrame': '2 year postop', 'description': 'Optical tracking system focusing on reflective markers according a model used in gait analysis together with force plates record hip moments (Nm/kg) in 3 planes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gait Analysis', 'Hip Fractures', 'Hip Arthroplasty', 'Randomized']}, 'referencesModule': {'references': [{'pmid': '38087800', 'type': 'DERIVED', 'citation': 'Zugner R, Tranberg R, Sharegi B, Karrholm J. Gait pattern in patients treated with a total hip arthroplasty due to an acute displaced cervical neck fracture: a randomised comparison between 29 cases with a cemented femoral stem and 16 cases with an uncemented femoral stem. Hip Int. 2024 May;34(3):421-427. doi: 10.1177/11207000231208099. Epub 2023 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'Acute cervical femoral neck fracture patients randomized to either cemented or non-cemented stem. The investigators used gait analysis to evaluate if patients operated with a cemented stem showed more favourable hip kinematics and kinetics when compared with a group of patients operated with a non-cemented stem.', 'detailedDescription': '45 patients randomized to receive either a cemented or a non-cemented stem were studied . 2 years after the operation gait analysis was performed with a 16-camera motion capture system together with 2 force-plates. Hip kinematics and kinetics were analysed and 70 subjects served as controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute collum femoris fracture\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04791605', 'briefTitle': 'Gait Pattern Between a Cemented and Non-cemented Femur Stem', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'No Difference in Gait Pattern Between a Cemented and Non-cemented Femur Stem. 45 Prospective Randomized Total Hip Arthroplasty Patients After Acute Cervical Femur Fracture Evaluated After 2 Years', 'orgStudyIdInfo': {'id': 'Cemented and non-cemented stem'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gait analysis of cemented total hip', 'description': 'Gait analysis of acute collum femoris fracture patient randomized to cemented stem', 'interventionNames': ['Other: Gait analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Gait analysis of non-cemented total hip', 'description': 'Gait analysis of acute collum femoris fracture patient randomized to non-cemented stem', 'interventionNames': ['Other: Gait analysis']}], 'interventions': [{'name': 'Gait analysis', 'type': 'OTHER', 'description': 'Kinematic and kinetic analysis', 'armGroupLabels': ['Gait analysis of cemented total hip', 'Gait analysis of non-cemented total hip']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE 41310', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Roland Zügner', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Roland Zügner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Göteborg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}