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

Hospital Regional Tlalnepantla

Status: Completed

Conditions: Proximal Femur Fracture

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05091359

02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Study group

Experimental group

Description:

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.

Treatment:

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

Control Group

No Intervention group

Description:

Participants without application of graft during hip implant.