PFN-A Augmentation for Intertrochanteric Femoral Fractures

Study Overview
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Brief Summary
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This study evaluates the potential negative effect of cement augmentation in the femoral head on viability of the head. Half of the participants will have the standard intramedullary nail (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail plus cement augmentation.

Detailed Description
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Cement augmentation is believed to increase the bone implant interface and therefore decrease the risk of implant cut-out of the femoral head. The cement used in previous studies has produced heat and thermal necrosis on bone cells. The cement used in this study (TraumaCemV+) is manufactured specially for this implant and for the augmentation of this implant. TraumaCemV sets under low temperature (40 degrees Celsius) and we do not anticipate any heat necrosis. The volume effect of the cement could theoretically also damage the blood flow in the femoral head. There have been no negative effects in big series of patients operated with this technique. The aim of this study is to quantify the viability of the femoral head with the use PET-CT (Positron Emission Tomography with simultaneous Computed Tomography) including a radioactive isotope (Fluorine-18) and the use of threedimensional computed tomography.

Official Title
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PFN-A Intramedullary Nail and Intertrochanteric Hip Fracture. Augmentation of the Femoral Head Assessed by PET-CT (Positron Emission Tomography - Computed Tomography)- a Randomized Trial

Conditions
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Intertrochanteric Fracture

Intervention / Treatment
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* Procedure: Cement augmentation
* Procedure: PFN-A Nail


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intertrochanteric Hip Fracture AO (Arbeitsgemeinschaft für Osteosynthesefragen) 31-A1 or AO 31-A2 Healthy contralateral hip ASA (American Society of Anesthesiologists) Physical Status Class I or II Exclusion Criteria: Dementia

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Nail<br>Hip fracture surgery with a PFN-A Nail (Proximal Femoral Nail Augmentation). | Procedure: PFN-A Nail<br> <br> |
| Experimental: Augmented Nail<br>Hip fracture surgery with a PFN-A Nail with Cement augmentation with TraumaCemV+ | Procedure: Cement augmentation<br> <br> Procedure: PFN-A Nail<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viability of the femoral head as assessed by fluoride uptake using PET-CT | The primary endpoint is the level of fluoride uptake (standardized uptake values: SUVs) representing bone metabolism. PET-CT enables us to quantify this tridimensionally. | 4 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viability of the femoral head as assessed by fluoride uptake using PET-CT |  | Within 1 week postoperatively | 
| Viability of the femoral head as assessed by fluoride uptake using PET-CT |  | 1 year postoperatively | 
| Harris Hip Score |  | 4 months | 
| Harris Hip Score |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Augmentation, PET-CT, Positron Emission Tomography, Fluorine-18