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

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.

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Key information

Conditions

Proximal Femur Fracture Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Proximal Femoral Fractures Wounds and Injuries

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study group with absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate paste

Device

Application of absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate in paste for prevent loosening of Dynamic Hip Screw implant

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.

Sponsors and collaborators

Lead sponsor

Hospital Regional Tlalnepantla

Other Gov

Registry information

Official study title

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

Acronym: geneX

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2019
First posted: Oct 25, 2021
Registry last updated: Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed