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

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ClinicalTrials.gov Identifier: NCT01673048
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : February 14, 2014
Sponsor:
Information provided by (Responsible Party):
Martin M Kaiser, 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.


Condition or disease Intervention/treatment Phase
Femoral Fracture Children Procedure: 3-Nail-ESIN in femoral shaft fractures Not Applicable

Detailed Description:
see above

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Femoral fracture, ESIN
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



Primary Outcome Measures :
  1. Intraoperative and postoperative complications [ Time Frame: 12 months ]
    All complications will be recorded: Intraoperative and postoperative complications, Re-Do operations


Secondary Outcome Measures :
  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 Outcome Measures:
  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




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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dislocated femoral fracture
  • ESIN osteosynthesis

Exclusion Criteria:

  • No given informed consent
  • Other osteosynthesis than ESIN

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673048


Locations
Germany
Department of Pediatric Surgery
Luebeck, Germany, 23538
Sponsors and Collaborators
University of Luebeck
Investigators
Principal Investigator: Martin M Kaiser, PD Dr. med. University Luebeck

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Martin M Kaiser, Consultant, University of Luebeck
ClinicalTrials.gov Identifier: NCT01673048     History of Changes
Other Study ID Numbers: 3ESINFemur
First Posted: August 27, 2012    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014

Keywords provided by Martin M Kaiser, University of Luebeck:
Elastic stable intramedullary nailing
biomechanical testing
fracture
femur
treatment
children
adolescents

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries