Modification of ESIN-osteosynthesis in a Femoral Fracture Model and Its Transmission to Clinical Practice

Study Overview
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Brief Summary
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Elastic stable intramedullary nailing (ESIN) is the standard treatment for displaced diaphyseal femoral fractures in children. However, some literature report high complication rates (10-50%) in complex fractures. Data of our own patients with special emphasis on complications showed also mediocre results. Thus, a biomechanical study was conducted to search for modifications. In this study the stiffness with a 3rd nail implanted was compared to the classical 2 C-shaped configuration. For each of the 3 configurations of retrograde ESIN (titanium nails) eight composite femoral grafts (Sawbones®) with an identical spiral fracture were used: 2C configuration (2 C-shaped nails, 2x3.5 mm), 3CM configuration (3rd from antero-medial, + 1x2.5 mm) and 3CL configuration (3rd from antero-lateral, + 1x2.5 mm). Each group underwent biomechanical testing in 4-point bending, IRO/ERO and axial compression (0°/9°). Due to a significantly higher stiffness of 3CL in the anterior-posterior, internal rotation and 9° compression directions implantation of 3 nails became standard treatment for all dislocated femoral fractures at our department. All patients were followed prospectively. The following data was collected: Type of osteosynthesis, any kind of complication (additional procedures like cast or external fixateur, Re-Do operations, misalignment, pseudarthrosis, skin irritation, infection), time until full weight bearing and time until implant removal. At follow-up the legs were controlled for a possible length discrepancy and a possible deviation of axis. Patients' satisfaction was controlled by CSQ (clients satisfaction score, Larsen et al 2002). Further on the Harris Hip Score was used. X-ray controls were done as standard care protocol after 1 and 3-4 months (dependend on age). Level of Evidence IV Keywords: Elastic stable intramedullary nailing, biomechanical testing, fracture, femur, treatment, children, adolescents.

Detailed Description
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see above

Official Title
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From Bench to Bedside: Modification of Elastic Stable Intramedullary Nailing With a 3rd Nail in a Femoral Spiral Fracture Model and Its Transmission to Clinical Practice

Conditions
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Femoral Fracture, Children

Intervention / Treatment
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* Procedure: 3-Nail-ESIN in femoral shaft fractures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dislocated femoral fracture ESIN osteosynthesis Exclusion Criteria: No given informed consent Other osteosynthesis than ESIN

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Femoral fracture, ESIN<br>Prospectively all patients treated with the 3-nail-configuration for dislocated femoral shaft fractures were enrolled; 25 patients are planned, 18 could be enrolled Comparison will be with own previous data of patients treated with the classical 2-C-shaped ESIN-osteosynthesis | Procedure: 3-Nail-ESIN in femoral shaft fractures<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative and postoperative complications | All complications will be recorded: Intraoperative and postoperative complications, Re-Do operations | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| misalignment | Follow up X-rays will be measured for misalignment in degrees (sagittal, frontal and transverse plane) Data will be grouped as a) 1 - 5° b) 6 - 10° c) 11 - 15° d)16 - 20° e) 20 - 30° f) > 30° | 12 m | 
| Pseudarthrosis |  | 12 m | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elastic stable intramedullary nailing, biomechanical testing, fracture, femur, treatment, children, adolescents