Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT02028468
Status:
COMPLETED
Last Update Posted:
2022-11-10
First Post:
2014-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterolateral Watson Jones Approach Versus Transgluteal Approach for Uncemented Hemi- Arthroplasty in Displaced Femoral Neck Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005265', 'term': 'Femoral Neck Fractures'}], 'ancestors': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'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': 'D062785', 'term': 'Hemiarthroplasty'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-09', 'studyFirstSubmitDate': '2014-01-03', 'studyFirstSubmitQcDate': '2014-01-03', 'lastUpdatePostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale Pain and Patient Satisfaction', 'timeFrame': 'Pre and postoperative, 3 and 12 Months'}], 'secondaryOutcomes': [{'measure': 'Timed up and go', 'timeFrame': 'postoperative, 3 and 12 Monthes', 'description': 'TUG test- Timed up and Go'}, {'measure': 'Harris Hip Score', 'timeFrame': 'Pre / Postoperative, 3 and 12 Months'}, {'measure': 'Hip Osteoarthritis Disability Score', 'timeFrame': 'Postoperative, 3 and 12 Months'}, {'measure': 'EuroQol', 'timeFrame': 'Postoperative, 3 and 12 Months'}]}, 'conditionsModule': {'keywords': ['Femoral Neck Fracture', 'Anterolateral approach', 'Trans-gluteal approach', 'Watson Jones approach', 'Hardinge approach'], 'conditions': ['Femoral Neck Fracture']}, 'referencesModule': {'references': [{'pmid': '29789919', 'type': 'DERIVED', 'citation': 'Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg OH, Pripp AH, Nordsletten L. Biomarkers of muscle damage increased in anterolateral compared to direct lateral approach to the hip in hemiarthroplasty: no correlation with clinical outcome : Short-term analysis of secondary outcomes from a randomized clinical trial in patients with a displaced femoral neck fracture. Osteoporos Int. 2018 Aug;29(8):1853-1860. doi: 10.1007/s00198-018-4557-y. Epub 2018 May 22.'}]}, 'descriptionModule': {'briefSummary': 'Hemiarthroplasty is a well established treatment of Femoral Neck Fractures in the Elderly. During the last decade the use of Minimal Invasive Surgical( MIS) approaches have been increasing. Our hypothesis is that Patients with a Femoral Neck Fracture may benefit from a MIS approach.', 'detailedDescription': "The study's main objective: The purpose of the study is to test the following hypothesis. Patients 70 to 90 years with a displaced femoral neck fracture, operated with a hemiarthroplasty through an anterolateral approach, have less pain and better patient satisfaction as measured by PROMs than patients operated through the lateral approach.\n\nThe study's subsidiary objectives. We aim to shed light on the following subsidiary hypotheses.\n\n1. A hemiarthroplasty inserted through an anterolateral approach gives less bone resorption, as measured by DEXA around the stem, than a hemiarthroplasty inserted via a direct lateral approach.\n2. A hemiarthroplasty inserted through an anterolateral approach causes lesser degree of muscle damage, as measured by CK, than a direct lateral approach"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Patients 70- 85 Years of Age -\n\nExclusion Criteria:\n\nDementia, Infection Not Suitable for Hemiarthroplasty\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02028468', 'briefTitle': 'Anterolateral Watson Jones Approach Versus Transgluteal Approach for Uncemented Hemi- Arthroplasty in Displaced Femoral Neck Fracture', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sorlandet Hospital HF'}, 'orgStudyIdInfo': {'id': '811419'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Anterolateral Approach', 'description': 'Patient Operated with Watson Jones Approach', 'interventionNames': ['Procedure: hemiarthroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trans-gluteal Approach', 'description': 'Patient operated with Trans-gluteal Hardinge Approach', 'interventionNames': ['Procedure: hemiarthroplasty']}], 'interventions': [{'name': 'hemiarthroplasty', 'type': 'PROCEDURE', 'armGroupLabels': ['Anterolateral Approach', 'Trans-gluteal Approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4604', 'city': 'Kristiansand', 'country': 'Norway', 'facility': 'Sorlandet Hospital', 'geoPoint': {'lat': 58.14671, 'lon': 7.9956}}], 'overallOfficials': [{'name': 'Lars Nordsletten, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oslo Ullevål'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorlandet Hospital HF', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}