Clinical trial NCT05091359: Femur Transtrochanteric Fractures Treated With Dynamic Hip Screw and Calcium Sulfate Scaffold.
Official title: Unstable Proximal Femur Transtrochanteric Fractures Treated With Dynamic Hip Screw and ß -Tricalcium Phosphate/ Hemihydrated Calcium Sulfate Graft Scaffold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proximal Femur Fracture
Keywords: Dynamic Hip Screw
DHS HIP FRACTURE
Lead sponsor: Hospital Regional Tlalnepantla
Sponsor class: OTHER_GOV
First posted: 2021-10-25
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two group comparison
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of cut - out failure of the dynamic hip screw implant in unstable transtrochanteric fractures
timeFrame: 12 weeks for each patient
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: HEAD OF THE ORTHOPEDIC SERVICE OF THE REGIONAL HOSPITAL TLALNEPANTLA ISSEMYM
name: JULIO C VELEZ, mD
role: PRINCIPAL_INVESTIGATOR
affiliation: JOINT SURGERY RESIDENT
name: SILVIA S SERRANO REYES, MD
role: STUDY_CHAIR
References:
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