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

Not Applicable

Completed

• Conditions: Children; Femoral Fracture
• Interventions: Procedure: 3-Nail-ESIN in femoral shaft fractures

• Registration Number: NCT01673048
• Lead Sponsor: University of Luebeck

Brief Summary

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

see above

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2012-08-12
• Study First Submitted QC: 2012-08-24
• Study First Posted: 2012-08-27
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-13
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Dislocated femoral fracture
• ESIN osteosynthesis

Exclusion Criteria

• No given informed consent
• Other osteosynthesis than ESIN

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Femoral fracture, ESIN	3-Nail-ESIN in femoral shaft fractures	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

Primary Outcome Measures

Name	Time	Method
Intraoperative and postoperative complications	12 months	All complications will be recorded: Intraoperative and postoperative complications, Re-Do operations

Secondary Outcome Measures

Name	Time	Method
Pseudarthrosis	12 m
misalignment	12 m	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°

Trial Locations

Locations (1)

Department of Pediatric Surgery; 🇩🇪 Luebeck, Germany