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Completed

NCT Number: NCT01673048

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

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.

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Key information

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric Surgery

Lübeck, 23538, Germany

About this study

see above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dislocated femoral fracture
  • ESIN osteosynthesis

Exclusion criteria

  • No given informed consent
  • Other osteosynthesis than ESIN

Treatment and study plan

3-Nail-ESIN in femoral shaft fractures

Procedure

Primary outcomes

  1. Intraoperative and postoperative complications

    Time frame: 12 months

    All complications will be recorded: Intraoperative and postoperative complications, Re-Do operations

Secondary outcomes

  1. misalignment

    Time frame: 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°

  2. Pseudarthrosis

    Time frame: 12 m

Other outcomes

  1. Limb discrepancy

    Time frame: 12 m

    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

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Registry information

Official study 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

Acronym: ESIN

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 27, 2012
Registry last updated
Feb 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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