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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01673048
Acronym
ESIN
Enrollment
18
Registered
2012-08-27
Start date
2009-01-31
Completion date
2012-12-31
Last updated
2014-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Femoral Fracture

Keywords

Elastic stable intramedullary nailing, biomechanical testing, fracture, femur, treatment, children, adolescents

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

Interventions

PROCEDURE3-Nail-ESIN in femoral shaft fractures

Sponsors

University of Luebeck
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Dislocated femoral fracture * ESIN osteosynthesis

Exclusion criteria

* No given informed consent * Other osteosynthesis than ESIN

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative and postoperative complications12 monthsAll complications will be recorded: Intraoperative and postoperative complications, Re-Do operations

Secondary

MeasureTime frameDescription
misalignment12 mFollow 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°
Pseudarthrosis12 m

Other

MeasureTime frameDescription
Limb discrepancy12 mboth 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026