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

September 11, 2016 updated by: Carlos Mario Olarte, Hospital Infantil Universitario de San Jose

Radiologic and Clinical Outcomes of Augmentation in Fragility Intertrochanteric Hip Fracture Treatment: A Randomized Multicenter Clinical Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To determine if the use of augmentation with PMMA in the treatment of fragility intertrochanteric hip fractures improves radiologic and clinical outcomes in osteoporotic patients, investigators aim to conduct a multicentered, randomized, single-blinded clinical trial.

All patients aged 65 years or older arriving to the emergency department of two level-1 trauma centers in Bogotá, Colombia; Hospital Universitario Fundación Santa Fe de Bogotá and Hospital Infantil Universitario de San José, after sustaining a fragility intertrochanteric hip fracture that requires open reduction and internal fixation (ORIF) will be included. These patients must be willing to accept a 1-year follow-up and are required to sign an informed consent agreeing to their participation in the study. For the sample calculation a two-tailed analysis with an alpha-level of significance of 0.05, a power of 80% (β = 0.2) was performed. A total of 35 patients per group plus a 30% increase to control for loss of follow-up was calculated. This gives a total of 90 patients; 45 patients per group.

Patients meeting inclusion and exclusion criteria will be recruited by convenience sampling as they arrive to the emergency department.

Once included in the study, patients will be stratified by age into two groups: patients aged between 65-85 years and patients over 85 years. Then, by using a block randomization, the intervention (augmentation) will be randomly allocated in order to divide the sample population into an intervention group (ORIF + augmentation with PMMA) and a control group (ORIF without augmentation). Randomization will be carried out by the program "Sealed Envelope" (https://www.sealedenvelope.com) that generates a list with codes (each code representing one patient) and randomly assigns them to either the intervention or the control group. This list will be in custody of a research assistant who will not have any contact with patients during the trial's duration and will be in charge of writing the allocation of each code into a sealed, opaque envelope. Each envelope will be given to the surgeon during the procedure at the precise moment where augmentation is needed, revealing whether or not augmentation should be performed. Medical care will be based on Orthogeriatric Programs and surgeries will be performed by orthopaedic surgeons with a clinical fellowship in Orthopaedic Trauma. Patients will be blinded to treatment and will be seen on follow-up visits 15 days, one month, 3 months, 6 months, and 12 months after the procedure.

The primary outcome will be the change in TAD measurement 1 year after the surgical procedure. The functional differences between both groups will be measured as secondary outcomes. Outcomes (primary and secondary) will be measured during follow-up visits one month, 3 months, 6 months, and 12 months after the procedure.

Results will be analyzed using STATA ® Data Analysis and Statistical Software, version 13.1. The sample's demographic and baseline characteristics will be described using descriptive statistics. Continuous variables will be reported as arithmetic means while categorical variables will be reported as absolute values of frequencies and distribution. For the inferential analysis of the results, a Shapiro Wilk W-Test will be used to determine normality distribution of values. If normality assumptions are met, the change in TAD measurement will be analyzed with a student t-test. If not, its non-parametric analogue (Mann-Whitney U-test) will be used. For all other categorical variables, a X2 or Fisher's exact test will be used.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogotá, Colombia
        • Recruiting
        • Fundacion Santa Fe de Bogota
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rodrigo F Pesantez, MD
        • Sub-Investigator:
          • Carlos M Olarte, MD
        • Sub-Investigator:
          • Daniela Sanchez, MD
        • Sub-Investigator:
          • Miguel A Farfan, MD
        • Sub-Investigator:
          • Rodrigo Jaramillo, MD
        • Sub-Investigator:
          • Julian Salavarrieta, MD
        • Sub-Investigator:
          • Sebastian Suarez, MD
        • Sub-Investigator:
          • Daniela Tafur, MD
      • Bogotá, Colombia
        • Recruiting
        • Hospital Infantil de San José
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Daniela Sanchez, MD
        • Principal Investigator:
          • Carlos M Olarte, MD
        • Sub-Investigator:
          • Daniel Quintero, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard treatment
open reduction and internal fixation TFNA
Procedure: open reduction and internal fixation
Open reduction and internal fixation using an intramedullary nail
Device: TFNA
Trochanteric Femoral Nail Advance
Experimental: Augmentation
open reduction and internal fixation TFNA Augmentation (Cement)
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The TAD will be measured in the immediate postoperative hip x-ray, one month, 3 months, 6 months, and 12 months after the procedure.
immediate postoperative hip x-ray (starting point), at one month, 3 months, 6 months, and 12 months after the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parker Mobility Score
Time Frame: one month, 3 months, 6 months, and 12 months after the procedure.
determine the pre-injury level of mobility and evaluate the functional recovery during the follow-up period.
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.
determine the health-related quality of life perceived by the patient, both before the injury and during the follow-up period
one month, 3 months, 6 months, and 12 months after the procedure.
Pain Visual Analogue Scale
Time Frame: one month, 3 months, 6 months, and 12 months after the procedure.
subjective evaluation of pain intensity
one month, 3 months, 6 months, and 12 months after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Infantil Universitario de San Jose

Collaborators

Fundación Santa Fe de Bogota

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 5, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 11, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIPFX-001-AUGM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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