Radiologic and Clinical Outcomes of Augmentation in Fragility Intertrochanteric Hip Fracture Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 19 September 2016
• Main ID: NCT02631824
• Date of registration: 05/12/2015
• Prospective Registration: No
• Primary sponsor: Hospital Infantil Universitario de San Jose
• Public title: Radiologic and Clinical Outcomes of Augmentation in Fragility Intertrochanteric Hip Fracture Treatment AFIF
• Scientific title: Radiologic and Clinical Outcomes of Augmentation in Fragility Intertrochanteric Hip Fracture Treatment: A Randomized Multicenter Clinical Trial
• Date of first enrolment: November 2015
• Target sample size: 90
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02631824
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Colombia

Contacts

• Name: Carlos M Olarte, MD
• Affiliation: Head of Orthopaedic Department at Hospital Infantil de San José

• Name: Daniela Sanchez, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- patients arriving to the emergency department after sustaining a fragility hip
fracture

- radiographic diagnosis of intertrochanteric fracture requiring open reduction and
internal fixation

- patient willing to accept a 1-year follow-up

- signature of informed consent

Exclusion Criteria:

- polytrauma

- patients with a non-fragility hip fracture (high-energy trauma)

- hip fractures due to primary or metastatic tumours,

- open or periprosthetic hip fractures

- patients with history of organ transplantation and patients with severe dementia.

- patients with iatrogenic perforation into the hip joint during procedure



Age minimum: 65 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hip Fractures

Intervention(s)

Device: Augmentation (Cement)

Device: TFNA

Procedure: open reduction and internal fixation

Primary Outcome(s)

Change in TAD measurement [Time Frame: immediate postoperative hip x-ray (starting point), at one month, 3 months, 6 months, and 12 months after the procedure.]

Secondary Outcome(s)

Pain Visual Analogue Scale [Time Frame: one month, 3 months, 6 months, and 12 months after the procedure.]

EQ-5D Questionnaire [Time Frame: one month, 3 months, 6 months, and 12 months after the procedure.]

Parker Mobility Score [Time Frame: one month, 3 months, 6 months, and 12 months after the procedure.]

Secondary ID(s)

HIPFX-001-AUGM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fundación Santa Fe de Bogota