Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-30 @ 11:27 AM
Study NCT ID:
NCT04870151
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2021-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "The outcomes assessors are instructed to assess the outcomes before they log in to the patients' journal. Thereby, they will not have information of the treatment allocation at the time of outcomes assessment. Also, they will not ask the patients to undress or in any other way examine the surgical site, as the location of the scar tissue may disclose the treatment allocation."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2021-04-30', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Harris Hip Score (HHS)', 'timeFrame': '12 months', 'description': 'Harris Hip Score (HHS) is an outcome measure for hip-related symptoms. The score is based on both patient-reported information and clinical examination, and is administered by a qualified health care professional. It covers four domains: Pain, function, absence of deformity and range of motion. The score ranges from 0 (worst) to 100 (best).'}], 'secondaryOutcomes': [{'measure': 'EuroQol questionnaire (EQ-5D)', 'timeFrame': '12 months', 'description': 'Quality of life is measured by the EuroQol questionnaire (EQ-5D). EQ-5D is a validated generic health-related quality-of-life instrument. It consists of two parts: EQ-5D descriptive part and EQ-5D visual analogue scale. The descriptive part includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with three possible answers ("no problems", "some problems", and "major problems"). EQ-5D VAS is a visual analogue scale of self-related overall health, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).'}, {'measure': 'Patient-reported limping', 'timeFrame': '12 months', 'description': 'Patient-reported limping is a sub-score of the Harris Hip Score. The patients describe their limping as (1) "none", (2) "slight", (3) "moderate" or (4) "severe or unable to walk".'}, {'measure': 'Patient-reported use of walking aid', 'timeFrame': '12 months', 'description': 'Patient-reported use of walking aid is a sub-score of the Harris Hip Score. The patients describe their use of walking aid as (1) "none", (2) "cane/walking stick for long walks", (3) "cane/walking stick most of the time", (4) "one crutch", (5) "two canes/walking sticks" or (6) "two crutches or unable to walk".'}, {'measure': 'Trendelenburg test', 'timeFrame': '12 months', 'description': 'Trendelenburg test is a clinical test for the integrity of hip abductor muscle function. The test is positive when the patient is unable to maintain the pelvis horizontal to the floor when standing on one leg.'}, {'measure': 'Timed Up and Go (TUG)', 'timeFrame': '12 months', 'description': 'The Timed Up and Go (TUG) test is a performance-based measure of functional mobility that was initially developed to identify mobility and balance impairments in older adults.\n\nThe patients start in a seated position, walk 3 meters, turn around, walk back to the chair and sit down. The time starts when the patient is commanded to start and stops when the patient is seated.'}, {'measure': 'Blood loss', 'timeFrame': 'During surgery', 'description': 'The peroperative amount of blood loss (milliliters) is registered'}, {'measure': 'Duration of surgery', 'timeFrame': 'During surgery', 'description': 'The duration of the surgical procedure (minutes) is registered'}, {'measure': 'Length of hospital stay', 'timeFrame': '12 months', 'description': 'The length of hospital stay (days) is registered'}, {'measure': 'Adverse events', 'timeFrame': '12 months', 'description': 'Adverse events such as perioperative complications, infections, dislocations and reoperations are registered'}, {'measure': 'Mortality', 'timeFrame': '12 months', 'description': 'In patients who die within 12 months follow-up, the time of death is registered'}, {'measure': 'Cause of death', 'timeFrame': '12 months', 'description': 'In patients who die within 12 months follow-up, the cause of death is registered'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgical approach', 'Hemiarthroplasty'], 'conditions': ['Hip Fractures']}, 'descriptionModule': {'briefSummary': 'Patients with dislocated hip fractures are randomised to cemented hemiarthroplasty with an anterolateral approach or a direct lateral approach.', 'detailedDescription': 'Dislocated intracapsular hip fractures are usually treated with cemented hemiarthroplasty. In Norway, a direct lateral approach is most often used, as recommended in national guidelines. In total hip arthroplasty, however, minimally invasive approaches are also commonly used, and may improve the clinical results, as compared to posterior or direct lateral approaches.\n\nThe aims of the present study are to evaluate the effect of the minimally invasive anterolateral approach (Watson-Jones approach) compared to the direct lateral approach (Hardinge approach) to the hip joint in hemiarthroplasty after dislocated hip fractures.\n\nPatients with dislocated hip fractures who are fit for cemented hemiarthroplasty are randomised to surgery with an anterolateral approach or a direct lateral approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* dislocated hip fracture.\n* planned cemented hemiarthroplasty.\n* able to walk, with or without walking aids, prior to the injury.\n\nExclusion Criteria:\n\n* young and healthy patients with displaced hip fractures who are recommended total hip arthroplasty or open reduction / internal fixation of the fracture.\n* patients with severe comorbidity and high risk of cement-related complications who are recommended uncemented hemiarthroplasty (some, but not all, patients with ASA (American Society of Anesthesiologists) grade 4).\n* not able to give informed consent.'}, 'identificationModule': {'nctId': 'NCT04870151', 'briefTitle': 'Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Sykehuset Innlandet HF'}, 'officialTitle': 'Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture: A Randomised Study', 'orgStudyIdInfo': {'id': '224045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anterolateral approach', 'description': 'The minimally invasive anterolateral approach (Watson-Jones approach) is performed with the patient in supine position. An oblique incision is made from just dorsal to the anterior superior iliac spine, and extended distally to the greater trochanter. After the fascia is incised, deep dissection continues in the plane between the tensor fasciae latae and the gluteus medius muscles. The joint capsule is exposed and opened. The femoral head and neck are resected and the femoral canal is reamed according to the preoperative plan.\n\nA femoral stem (Link Lubinus SPII) is fixed using bone cement (Heraeus Medical Palacos R+G pro) and connected to a bipolar femoral head (Zimmer Multipolar).\n\nAfter implantation of the prosthesis, the fascia, subcutis and skin is closed in separate layers with sutures.', 'interventionNames': ['Procedure: Anterolateral approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Direct lateral approach', 'description': 'The direct lateral approach (Hardinge approach) is performed with the patient in a lateral decubitus position. A straight or curved longitudinal incision is made over the greater trochanter, and the fascia is incised longitudinally. The anterior aspect of the gluteus medius and minimus muscles are separated from the greater trochanter. The joint capsule is exposed and opened. The femoral head and neck are resected and the femoral canal is reamed according to the preoperative plan.\n\nA femoral stem (Link Lubinus SPII) is fixed using bone cement (Heraeus Medical Palacos R+G pro) and connected to a bipolar femoral head (Zimmer Multipolar).\n\nAfter implantation of the prosthesis, the gluteus medius and minimus muscles are reinserted using osteosutures. The fascia, subcutis and skin is closed in separate layers with sutures.', 'interventionNames': ['Procedure: Direct lateral approach']}], 'interventions': [{'name': 'Anterolateral approach', 'type': 'PROCEDURE', 'description': 'Cemented hemiarthroplasty using an anterolateral approach.', 'armGroupLabels': ['Anterolateral approach']}, {'name': 'Direct lateral approach', 'type': 'PROCEDURE', 'description': 'Cemented hemiarthroplasty using a direct lateral approach.', 'armGroupLabels': ['Direct lateral approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2819', 'city': 'Gjøvik', 'state': 'Innlandet', 'country': 'Norway', 'facility': 'Innlandet Hospital Trust', 'geoPoint': {'lat': 60.79574, 'lon': 10.69155}}], 'overallOfficials': [{'name': 'Håvard Furunes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sykehuset Innlandet HF'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We have planned to use all the IPD only within the present study group.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sykehuset Innlandet HF', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}