Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-30 @ 7:30 PM
Study NCT ID:
NCT05587660
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2022-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Functional Outcomes in Unisplaced Neck of Femur Fracture Treated With Partially Threaded and Fully Threaded Cannulated Screw Fixation in Patients of Age 60 and Above
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005265', 'term': 'Femoral Neck Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Randomization to be done through lottery method and then the allocation to be made in both study groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2022-10-17', 'studyFirstSubmitQcDate': '2022-10-17', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Harris Hip Score (RUSH SCORE)', 'timeFrame': '6-months', 'description': 'Harris Hip Score (RUSH SCORE) is the method to assess the result of hip surgery and is intended to evaluate various hip disabilities and methods of treatment. RUSH Score was calculated with "Rradiographic Union Score for Hip (RUSH)", designed to improve intra-and inter-observer reliability when describing the radiographic healing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cannulated screw', 'fracture', 'Hip Harris score'], 'conditions': ['Neck of Femur Fracture']}, 'referencesModule': {'references': [{'pmid': '37680815', 'type': 'DERIVED', 'citation': 'Awais MZ, Salik E, Bokhari SHR, Iqbal MT. A comparative study of early functional outcomes in undisplaced neck of femur fracture treated with partially threaded and fully threaded cannulated screw fixation in patients above 60 years age. Pak J Med Sci. 2023 Sep-Oct;39(5):1531-1534. doi: 10.12669/pjms.39.5.7330.'}]}, 'descriptionModule': {'briefSummary': 'This study is done to compare the partially threaded versus fully threaded cannulated screw fixation methods in stable neck of femur fracture in terms of early functional outcomes in patients of age 60 and above. A total of 82 (41 in each group) patients of both genders, aged 60 or above. The Radiographic Union Scale for Hip (RUSH) and Harris Hip score to be used to evaluate fracture healing.', 'detailedDescription': 'This study is done to compare the partially threaded versus fully threaded cannulated screw fixation methods in stable neck of femur fracture in terms of early functional outcomes in patients of age 60 and above. This is a randomized controlled trial where a total of 82 (41 in each group) patients of both genders, aged 60 or above. All these patients had garden type I or II and were mobile before femoral neck fracture were included. In Group-A patients cannulated screw fixation was done using partially threaded screws and in Group-B patients were treated with fully threaded screws were used. Patients were treated according to following schedule and were followed up at 6 weeks, 3 months and 6 months interval. The Radiographic Union Scale for Hip (RUSH) and Harris Hip score were used to evaluate fracture healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of garden type I or II fractures.\n* All patients to be mobile before femoral neck fracture.\n\nExclusion Criteria:\n\n* Patients having open fracture.\n* Patients with present or past history of chronic kidney disorder.\n* Patients presenting with hemorrhage.\n* Patient with nervous stroke\n* Patients unwilling to be part of this study.'}, 'identificationModule': {'nctId': 'NCT05587660', 'briefTitle': 'Early Functional Outcomes in Unisplaced Neck of Femur Fracture Treated With Partially Threaded and Fully Threaded Cannulated Screw Fixation in Patients of Age 60 and Above', 'organization': {'class': 'OTHER', 'fullName': 'Nishtar Medical University'}, 'officialTitle': 'Early Functional Outcomes in Unisplaced Neck of Femur Fracture Treated With Partially Threaded and Fully Threaded Cannulated Screw Fixation in Patients of Age 60 and Above', 'orgStudyIdInfo': {'id': 'NishtarMU123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Partially threaded cannulated screw fixation', 'description': 'In Group-A patients, cannulated screw fixation was done using partially threaded screws. In this procedure, first step was insertion of three guide wires under image. The 1st guide wire was inserted immediately above calcar and into femoral head. The second wire was placed posteriorly adjacent to posterior cortex of neck on lateral view. Finally, third guide wire was placed anteriorly and superiorly. Drilling of lateral cortex was done before insertion of screws. Then partially threaded screw fixation was done before removal of guide wires using washers.', 'interventionNames': ['Procedure: Fully threaded cannulated screws']}, {'type': 'EXPERIMENTAL', 'label': 'Fully threaded cannulated screws fixation', 'description': 'The surgical approach in fully thread cannulated screws fixation group will remain same but instead of partially threaded screwsm fully threaded screws to be used in this group.', 'interventionNames': ['Procedure: Fully threaded cannulated screws']}], 'interventions': [{'name': 'Fully threaded cannulated screws', 'type': 'PROCEDURE', 'description': 'The most popular method in undisplaced neck of femur fracture include internal fixation by cannulated screws in which screws can be inserted relatively simply and atraumatically as compared to other methods. Screws can be used partially threaded or fully threaded; however studies on fully threaded screw fixation method are inconclusive.', 'armGroupLabels': ['Fully threaded cannulated screws fixation', 'Partially threaded cannulated screw fixation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63100', 'city': 'Multan Khurd', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Nishtar Medical University Hospital', 'geoPoint': {'lat': 33.03555, 'lon': 72.01752}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nishtar Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Gynecologist', 'investigatorFullName': 'Rashida Parveen', 'investigatorAffiliation': 'Nishtar Medical University'}}}}