Proximal Femur Fracture
Conditions
Keywords
Dynamic Hip Screw, DHS HIP FRACTURE
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.
Interventions
DEVICEStudy group with absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate paste
Application of absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate in paste for prevent loosening of Dynamic Hip Screw implant
Sponsors
Hospital Regional Tlalnepantla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The procedure was elected by participant randomization.
Intervention model description
A two group comparison
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cut - out failure of the dynamic hip screw implant in unstable transtrochanteric fractures | 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. |
Outcome results
None listed