Modification of ESIN-osteosynthesis in a Femoral Fracture Model and Its Transmission to Clinical Practice
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Femoral Fracture Children |
Procedure: 3-Nail-ESIN in femoral shaft fractures |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Intraoperative and postoperative complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]All complications will be recorded: Intraoperative and postoperative complications, Re-Do operations
- misalignment [ Time Frame: 12 m ] [ Designated as safety issue: No ]
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°
- Pseudarthrosis [ Time Frame: 12 m ] [ Designated as safety issue: No ]
- Limb discrepancy [ Time Frame: 12 m ] [ Designated as safety issue: No ]
both legs will be measured from spina iliaca anterior superior to the lateral malleolus in cm.
Results will be grouped as:
a) 0 - 0.5 cm b) 0.6 - 1.0 cm c) 1.1 - 1.5 cm d) 1.6 - 2.0 cm e)> 2 cm
| Estimated Enrollment: | 25 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Femoral fracture, ESIN
Prospectively all patients treated with the 3-nail-configuration for dislocated femoral shaft fractures were enrolled; 25 patients are planned. 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 |
Detailed Description:
see above
Eligibility| Ages Eligible for Study: | 3 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Dislocated femoral fracture
- ESIN osteosynthesis
Exclusion Criteria:
- No given informed consent
- Other osteosynthesis than ESIN
Contacts and Locations| Contact: Martin M Kaiser, PD Dr. med. | 0049451500 ext 2127 | kaiser@uni-luebeck.de |
| Germany | |
| Department of Pediatric Surgery | Completed |
| Luebeck, Germany, 23538 | |
| Department of Pediatric Surgery | Recruiting |
| Luebeck, Germany, 23538 | |
| Contact: Martin M Kaiser, PD Dr. med. | |
| Principal Investigator: Martin M Kaiser, PD Dr. med. | |
| Principal Investigator: | Martin M Kaiser, PD Dr. med. | University Luebeck |
More Information
Additional Information:
Publications:
| Responsible Party: | Martin M Kaiser, Consultant, University of Luebeck |
| ClinicalTrials.gov Identifier: | NCT01673048 History of Changes |
| Other Study ID Numbers: | 3ESINFemur |
| Study First Received: | August 12, 2012 |
| Last Updated: | August 24, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Luebeck:
|
Elastic stable intramedullary nailing biomechanical testing fracture femur |
treatment children adolescents |
Additional relevant MeSH terms:
|
Femoral Fractures Fractures, Bone Wounds and Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 16, 2013