Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-03 @ 8:10 AM
Study NCT ID:
NCT06491420
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is There a Role for Hip Arthroscopy in Patients With Femoral Head Fractures?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001182', 'term': 'Arthroscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A single limb interventional study where all cases presenting with pipkin 1 fractures are treated with arthroscopy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-01', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non Arthritic Hip Score', 'timeFrame': '6 months', 'description': 'The Following five questions concern the amount of pain: 1 Walking on a flat surface? 2 Going up or down stairs? 3 At night while in bed? 4 Sitting or lying? 5 tanding upright? the scoring for each question is from 0 to 4'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Femur Head Fracture', 'Arthroscopy']}, 'descriptionModule': {'briefSummary': 'Femoral head fractures, often caused by high-energy trauma, pose significant challenges due to complications like avascular necrosis, post-traumatic osteoarthritis, and sciatic nerve damage. While traditionally treated with open reduction and internal fixation (ORIF) or total hip replacement (THR), hip arthroscopy has emerged as a minimally invasive alternative that reduces surgical trauma, offers direct fracture visualization and manipulation, and may result in shorter recovery times and fewer complications.', 'detailedDescription': "Femoral head fractures are uncommon but serious injuries often happen because of high-energy trauma, such as traffic accidents or falls from heights. These fractures can result in complications such as avascular necrosis (if associated with hip dislocations), post-traumatic osteoarthritis, heterotopic ossification, and sciatic nerve damage. The management of femoral head fractures is challenging and depends on several variables, such as the fracture pattern, the degree of displacement, the existence of associated injuries, and the patient's age and physical activity.\n\nTraditionally, open reduction and internal fixation (ORIF) or total hip replacement (THR) have been the treatment of femoral head fractures, depending on the extent of the damage and the patient's expectations. However, these procedures have some drawbacks, such as increased blood loss, infection risk, surgical trauma, and implant-related complications. Furthermore, THR might not be appropriate for young, active patients who wish to maintain their natural hip joint, whereas ORIF might not be able to adequately reduce and fixate the fracture fragments, particularly in situations of comminution or impaction.\n\nNevertheless, hip arthroscopy has surfaced as a minimally invasive alternative for the treatment of selected femoral head fractures. Arthroscopy could be useful in femoral head fractures as it minimizes surgical aggression, in contrast to surgical hip dislocation applied in ORIF, allowing for direct control of fracture reduction, minimizing surgical morbidity, and optimizing early recovery. Hip arthroscopy allows for direct visualization and manipulation of the fracture fragments, as well as the removal of loose bodies and debris from the joint. Hip arthroscopy can also be combined with percutaneous fixation techniques to stabilize the fracture and restore joint congruence. When compared to open surgery, hip arthroscopy may offer several benefits, including shorter recovery times, less discomfort, less blood loss, and better cosmetic results. Arthroscopic-assisted percutaneous fixation has been reported as an effective treatment in selected cases of femoral head fractures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with pipkin 1 fractures\n\nExclusion Criteria:\n\n* any associated pelvic fractures\n* severe medical conditions that prevent the patient from undergoing surgery\n* delayed presentation after 2 weeks from initial fracture date'}, 'identificationModule': {'nctId': 'NCT06491420', 'briefTitle': 'Is There a Role for Hip Arthroscopy in Patients With Femoral Head Fractures?', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Is There a Role for Hip Arthroscopy in Patients With Femoral Head Fractures?', 'orgStudyIdInfo': {'id': 'MD-038-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with pipin 1 fractures fixed with arthroscopy', 'description': 'Accurate portal placement was essential for optimal visualization and safe access to the hip joint.\n\n* The anterolateral, anterior, and distal lateral accessory portals were utilized for arthroscopic labral repair.\n* The anterolateral portal was placed approximately 1-2 cm superior to the tip of the greater trochanter and 1-2 cm anterior, at an angle of 15° to 20° relative to the floor.\n* The anterior portal was established for visualization of the posterior-superior capsule, posterior-superior labrum, posterior recess, femoral head, ligamentum teres, and other structures.\n* The distal lateral accessory portal was placed after traction was released and the operative knee was flexed to 45°.\n\nAfter reducing the fracture under arthroscopic guidance, a guidewire fixed the fracture a cannulated screw was passed over the wire to fix the fracture.', 'interventionNames': ['Other: fixation with arthroscopy']}], 'interventions': [{'name': 'fixation with arthroscopy', 'type': 'OTHER', 'description': 'the pipkin fracture is fixed with the help of arthroscopy and percutaneous methods.', 'armGroupLabels': ['Patients with pipin 1 fractures fixed with arthroscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11956', 'city': 'Cairo', 'state': 'Manial', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed O Sabry, MBBS', 'role': 'CONTACT', 'email': 'sniperrifle22@gmail.com', 'phone': '+201117632926'}], 'facility': 'Kasr Al Ainy-Cairo University- Faculty of Medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed Hazem, MD', 'role': 'CONTACT', 'email': 'azeem@kasralainy.edu.eg', 'phone': '+20 122 330 3789'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The author will share it upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Ahmed Omar Sabry', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}