Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT06360835
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2024-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Our Experience in the Management of Therapeutic Failures of Fractures of the Proximal End of the Femur (About 35 Cases)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092526', 'term': 'Proximal Femoral Fractures'}, {'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': 'D019644', 'term': 'Arthroplasty, Replacement, Hip'}, {'id': 'D001860', 'term': 'Bone Plates'}], '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'}, {'id': 'D016268', 'term': 'Internal Fixators'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Approach', 'timeFrame': 'from enrollment to the of treatment 6 years', 'description': 'type of approach'}, {'measure': 'Preparation of the Patient', 'timeFrame': 'from enrollment to the of treatment 6 years', 'description': 'type of preparation'}, {'measure': 'Anesthesia', 'timeFrame': 'from enrollment to the of treatment 6 years', 'description': 'type of anesthesia'}, {'measure': 'Type of Surgical Revision', 'timeFrame': 'from enrollment to the of treatment 6 years', 'description': 'material implanted for revision'}, {'measure': 'Types of Prosthesis', 'timeFrame': 'from enrollment to the of treatment 6 years', 'description': 'prothesis used'}], 'secondaryOutcomes': [{'measure': 'Age Distribution', 'timeFrame': 'from enrollment to the end of treatment 6 years', 'description': 'The average age of patients experiencing therapeutic failure after surgical treatment of proximal femur fractures was 66 years, with ages ranging from 28 to 94 years. The age group 50-90 years constituted 68.59% of cases.'}, {'measure': 'Distribution by Sex', 'timeFrame': 'from enrollment to the end of treatment 6 years', 'description': 'Females represented a slight majority in the study, accounting for 57% (20 women), while males comprised 43% (15 men).'}, {'measure': 'Distribution According to Affected Side', 'timeFrame': 'from enrollment to the end of treatment 6 years', 'description': 'The right side was affected in 60% (21 cases), while the left side was affected in 40% (14 cases).'}, {'measure': 'Distribution According to Circumstances of Trauma', 'timeFrame': 'from enrollment to the end of treatment 6 years', 'description': 'Fractures were predominantly due to minimal trauma, with rare occurrences related to road accidents or domestic falls, attributed to bone fragility and muscle atrophy. One case of a pathological fracture was observed in a patient with dislocation of an intermediate hip prosthesis due to ovarian cancer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['femoral neck fracture', 'pertrochanteric fracture', 'internal osteosynthesis', 'mechanical complications'], 'conditions': ['Proximal Femur Fractures']}, 'descriptionModule': {'briefSummary': 'Osteosyntheses employed in treating fractures at the upper end of the femur play a critical role in facilitating a swift recovery by minimizing immobilization periods and enabling early rehabilitation of the affected joints, thereby promoting a speedy return to normal walking function.\n\nOsteosynthesis alters the mechanical dynamics of the bone segment, which undergoes continual changes during the consolidation and mobilization phases of recovery. Throughout these stages, a range of mechanical complications may arise, posing challenges despite the successful prevention of infections. Non-infectious complications associated with the presence of osteosynthesis materials, especially in weight-bearing areas like the lower limb, remain a concern.\n\nIn light of these considerations, surgeons must exercise meticulous care in selecting synthetic materials to mitigate the risk of osteosynthesis failures. In cases where internal fixation fails, the standard recourse often involves converting to total hip arthroplasty (THA).\n\nHowever, it is essential to note that THA subsequent to complications arising from proximal femur osteosynthesis presents a higher incidence of both intraoperative and postoperative complications compared to the implantation of primary total hip prostheses. Thus, while osteosynthesis remains a valuable intervention for femur fractures, careful attention to material selection and postoperative management is crucial in optimizing patient outcomes and minimizing complications.', 'detailedDescription': 'The aim was to identify the causes of mechanical failures of osteosynthesis in order to prevent them. Methods: We present the experience of the Department of Surgical Orthopedic Surgery, concerning 35 cases summarized after failure of surgical treatment of a fracture of the proximal end of the femur for a period spreading between January 2015 and December 2021. . The literature already found evidence of the greater complexity of this type of procedure compared to a first-line total hip prosthesis. Accordingly, all this, Prevention is better than cure these stiffnesses through good preoperative planning. Other factors related to the terrain or to untimely loading of the implant are more difficult to control. Whatever the cause, the surgeon remains by the rigor in these indications, the choice of the synthetic material the essential element in the prevention of osteosynthesis failures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cases of recurrent fractures of the proximal end of the femur following surgical treatment failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Diagnosis of a fracture of the proximal end of the femur.\n\n * Subsequent surgical intervention(s) due to failure of initial surgical treatment\n\nExclusion Criteria:\n\n* • Those initially treated with total hip arthroplasty.\n\n * Patients lost to follow-up, not consistently monitored, or untreated after diagnosis of the complication.\n * Cases with incomplete medical records'}, 'identificationModule': {'nctId': 'NCT06360835', 'briefTitle': 'Our Experience in the Management of Therapeutic Failures of Fractures of the Proximal End of the Femur (About 35 Cases)', 'organization': {'class': 'OTHER', 'fullName': 'Ibn Jazzar Hospital'}, 'officialTitle': 'Our Experience in the Management of Therapeutic Failures of Fractures of the Proximal End of the Femur (About 35 Cases)', 'orgStudyIdInfo': {'id': 'IRB00001193'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cases of recurrent fractures of the proximal end of the femur following surgical treatment failure', 'interventionNames': ['Procedure: total hip arthroplasty']}], 'interventions': [{'name': 'total hip arthroplasty', 'type': 'PROCEDURE', 'otherNames': ['plate', 'dynamic condylar screw'], 'armGroupLabels': ['cases of recurrent fractures of the proximal end of the femur following surgical treatment failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3190', 'city': 'Kairouan', 'country': 'Tunisia', 'facility': 'IBN jazzar hospital', 'geoPoint': {'lat': 35.6781, 'lon': 10.09633}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'use for other resaerchs'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ibn Jazzar Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Zied Mansi', 'investigatorAffiliation': 'Ibn Jazzar Hospital'}}}}