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

Not Applicable

Completed

• Conditions: Proximal Femur Fracture
• Interventions: Device: Study group with absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate paste

• Registration Number: NCT05091359
• Lead Sponsor: Hospital Regional Tlalnepantla

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.

Study Timeline

• Study Start: 2015-04-01
• Primary Completion: 2018-06-01
• Study Completion: 2019-05-10
• Study First Submitted: 2021-09-03
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-12
• Last Update Submitted: 2021-10-12
• Study First Posted: 2021-10-25
• Last Update Posted: 2021-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Study group with absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate paste	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.

Primary Outcome Measures

Name	Time	Method
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.