Radiologic and Clinical Outcomes of Augmentation in Fragility Intertrochanteric Hip Fracture Treatment
NCT02631824 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2016-09-13
Summary
Randomized clinical trial to assess if the use of augmentation in the treatment of fragility intertrochanteric hip fractures improves radiologic and clinical outcomes in patients aged 65 years or older 1 year after surgery
Conditions
- Hip Fractures
Interventions
- PROCEDURE
-
open reduction and internal fixation
Open reduction and internal fixation using an intramedullary nail
- DEVICE
-
TFNA
Trochanteric Femoral Nail Advance
- DEVICE
-
Augmentation (Cement)
Cement placement (3-6ml) through the cephalic blade under fluoroscopic vision. Cement contains 40% zirconuim dioxide, 15% hydroxiapatite, 45% polymethyl methacrylate (PMMA).
Sponsors & Collaborators
-
Fundación Santa Fe de Bogota
collaborator OTHER -
Hospital Infantil Universitario de San Jose
lead OTHER
Principal Investigators
-
Carlos M Olarte, MD · Head of Orthopaedic Department at Hospital Infantil de San José
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-11-30
- Primary Completion
- 2017-11-30
- Completion
- 2017-12-31
Countries
- Colombia
Study Locations
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