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

Study Overview
=================
Brief 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

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.

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

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Procedure: open reduction and internal fixation
* Device: TFNA
* Device: Augmentation (Cement)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment<br>open reduction and internal fixation TFNA | Procedure: open reduction and internal fixation<br>* Open reduction and internal fixation using an intramedullary nail<br>Device: TFNA<br>* Trochanteric Femoral Nail Advance<br>|
| Experimental: Augmentation<br>open reduction and internal fixation TFNA Augmentation (Cement) | Procedure: open reduction and internal fixation<br>* Open reduction and internal fixation using an intramedullary nail<br>Device: TFNA<br>* Trochanteric Femoral Nail Advance<br>Device: Augmentation (Cement)<br>* Cement placement (3-6ml) through the cephalic blade under fluoroscopic vision. Cement contains 40% zirconuim dioxide, 15% hydroxiapatite, 45% polymethyl methacrylate (PMMA).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TAD measurement | 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 | 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 | 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 | subjective evaluation of pain intensity | one month, 3 months, 6 months, and 12 months after the procedure. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fragility fractures, hip fractures, augmentation, tip-apex distance