Femur Transtrochanteric Fractures Treated With Dynamic Hip Screw and Calcium Sulfate Scaffold.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Unstable Proximal Femur Transtrochanteric Fractures Treated With Dynamic Hip Screw and ß -Tricalcium Phosphate/ Hemihydrated Calcium Sulfate Graft Scaffold

Conditions
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Proximal Femur Fracture

Intervention / Treatment
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* Device: Study group with absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate paste


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A two group comparison
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Participants in which absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate paste at the time of the placement of the hip implant to prevent loosening of it's unstable trans-trochanteric fractures of the proximal femur, were applied. | Device: Study group with absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate paste<br>* Application of absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate in paste for prevent loosening of Dynamic Hip Screw implant<br>|
| No Intervention: Control Group<br>Participants without application of graft during hip implant. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cut - out failure of the dynamic hip screw implant in unstable transtrochanteric fractures | 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. | 12 weeks for each patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dynamic Hip Screw, DHS HIP FRACTURE