NCT05091359

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Hospital Regional Tlalnepantla · Other Government
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Proximal Femur Fracture

Interventions

Type	Name	Description
DEVICE	Study 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

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-06-01
• Completion: 2019-05-10
• First posted: 2021-10-25
• Last updated: 2021-10-25