- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07409909
Total Hip Arthroplasty Versus Bipolar Hemiarthroplasty for Treatment of Intracapsular Displaced Fracture Neck Femur in Elderly Active Patients
Total Hip Arthroplasty Versus Bipolar Hemiarthroplasty for Treatment of Intracapsular Displaced Fracture Neck Femur in Elderly Active Patients; Single-center Randomized Controlled Trial
Femoral neck fracture (FNF) is a worldwide health problem that can cause significant morbidity and mortality. Most femoral neck fractures are associated with a fall, and the risk factors include osteoporosis, chronic medication use, and reduced level of activity.
Femoral neck fractures are among the most common injuries in the elderly, and their number continues to increase with a more aged population.
In the elderly, femoral neck fractures may lead to significant mortality and morbidity, with impaired mobility and loss of independence. Given their high incidence and associated detrimental effects on patient lives.
The femoral neck fracture is a major type of hip fracture, whose treatment includes internal fixation, hemiarthroplasty (HA), or total hip arthroplasty (THA). The decision depends on multiple variables, including fracture pattern, surgeon comfort, and the patient's age, health, and ambulatory status. Internal fixation is a preferred management option for young people or the elderly who are intolerant of prosthesis surgery. THA and HA are widely used in displaced femoral neck fractures in the elderly. Surgery in these patients is undertaken to facilitate nursing and provide timely pain relief, rapid mobilization, and accelerated rehabilitation In general, HA has the advantages of shorter operation time, less blood loss, less technical demand, less economic burden, and a lower dislocation rate. However, some patients treated with HA require conversion to THA due to complications such as acetabular erosion.
THA, on the other hand, has been associated with superior patient satisfaction and better hip function, less acetabular erosion, and a lower revision rate. However, increased surgical complexity, operation time, and blood loss, as well as higher dislocation rates in THA for FNFs, remain a concern
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Faculty of Medicine, for Girls, Al-Zhar University, Egpyt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- were aged ≥ 65 years
- with a displaced intracapsular fracture of the femoral neck (Garden type III, IV).
Exclusion Criteria:
- extracapsular fracture of the femoral neck
- Pathological fractures, or open fractures
- Active infections at or near the hip joints.
- bedridden, immobile, or cognitively impaired patients
- patients with associated pelvic or acetabular fractures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Total Hip Arthroplasty
|
Patients will have total hip arthroplasty for managing neck femur fracture
|
|
Active Comparator: Bipolar Hemiarthroplasty
|
Patients in the control group with femur fracture will have bipolar hemiarthroplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
functional improvement
Time Frame: 12 months
|
will be assessed via modified Harris Hip Score.
The score is calculated based on four parameters: pain (0-44 points), function (0-47 points), absence of deformity (0-4 points), and range of motion (0-5 points).
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2221-2/1/2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Total Hip Arthroplasty (THA)
-
Bispebjerg HospitalNot yet recruitingTotal Hip Arthroplasty (THA) | Revision Hip Arthroplasty
-
Musgrave Park HospitalBelfast Health and Social Care Trust; Queen's University, Belfast; Belfast Arthroplasty...CompletedTotal Hip Replacement | Total Hip Arthroplasty | THA | THRUnited Kingdom
-
Muğla Sıtkı Koçman UniversityRecruiting
-
University Hospital, BonnRecruiting
-
Medacta International SARecruiting
-
Hospital del MarCompletedTotal Hip Arthroplasty (THA)Spain
-
Medacta International SANot yet recruitingTotal Hip Arthroplasty (THA)
-
University College Hospital GalwayRecruitingTotal Hip Arthroplasty (THA)Ireland
-
University Tunis El ManarRecruitingTotal Hip Arthroplasty (THA)Tunisia
-
Societe dEtude, de Recherche et de FabricationRecruitingTotal Hip Arthroplasty (THA)France
Clinical Trials on Total Hip Arthroplasty
-
Smith & Nephew, Inc.Active, not recruitingAdvanced Degeneration of the Hip Joint | Revision of the Hip JointUnited States, Australia, Canada, Hong Kong
-
Suzhou MicroPort OrthoRecon Co. LTDCompleted
-
University of ConnecticutCompletedOsteo Arthritis Knee | Hip Osteoarthritis | Protein-Energy Malnutrition | Orthopedic | Energy Malnutrition ProteinUnited States
-
Istituto Clinico HumanitasCompleted
-
Orthopedic Hospital Vienna SpeisingCompletedTotal Hip ArthroplastyAustria
-
Istanbul University - Cerrahpasa (IUC)CompletedObesity | ArthropathyTurkey
-
DePuy OrthopaedicsTerminatedOsteoarthritis | Degenerative Arthritis | Revision ArthroplastyCanada
-
Rothman Institute OrthopaedicsCompleted
-
Western University, CanadaRecruiting
-
Zimmer BiometTerminatedJoint Diseases | Osteoarthritis, Hip | Avascular Necrosis of Hip | Congenital Dysplasia of the Hip | Degenerative Joint Disease of Hip | Rheumatoid Arthritis of Hip | Post-Traumatic Osteoarthritis of HipCanada