Unstable Proximal Femur Transtrochanteric Fractures Treated With Dynamic Hip Screw and ß -Tricalcium Phosphate/ Hemihydrated Calcium Sulfate Graft Scaffold
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Proximal Femur Fracture
- Sponsor
- Hospital Regional Tlalnepantla
- Enrollment
- 36
- Primary Endpoint
- Incidence of cut - out failure of the dynamic hip screw implant in unstable transtrochanteric fractures
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a randomised prospective comparison study to evaluate the incidence of cut - out failure of the dynamic hip screw implant alone compared to the dynamic hip screw adding calcium sulfate through the cervical canal before placing the sliding screw for improvement of the implant stability integration and bone healing.
Detailed Description
Transtrochanteric fractures are a frequent entity, mainly in patients over 65 years old, with low bone density. Most of these fractures of the proximal femur are treated effectively with internal fixation with dynamic hip screw (DHS), nonetheless a conditional factor in the treatment success its in the fracture stability and in the osteoporosis severity. There is controversy in the treatment decision in patients with osteoporosis and an unstable fracture added the risk of peri-prosthetic infection or increased bleeding during surgery means that the decision to place a DHS versus a prosthesis is debated. This study represents the first comparison of closed reduction and internal fixation with DHS using calcium sulfate graft versus conventional DHS procedure.
Investigators
Julio Carlos Velez de Lachica
Md. High Specialty Associate Professor of the Joint Surgery Course
Hospital Regional Tlalnepantla
Eligibility Criteria
Inclusion Criteria
- •Patients between 65 and 80 years old
- •Patients classified as 31A1.3 and all 31A2 by the Orthopaedic Trauma Association classification system.
Exclusion Criteria
- •Patients with stable hip fractures
- •Participants who do not accept the randomization process
- •patients who do not complete follow-up during the study
Outcomes
Primary Outcomes
Incidence of cut - out failure of the dynamic hip screw implant in unstable transtrochanteric fractures
Time Frame: 12 weeks for each patient
The aim of this study is to evaluate the incidence of cut - out failure of the dynamic hip screw implant alone compared to the dynamic hip screw adding calcium sulfate through the cervical canal before placing the sliding screw to improve implant integration and bone healing.