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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martin M Kaiser, University of Luebeck
ClinicalTrials.gov Identifier:
NCT01673048
First received: August 12, 2012
Last updated: February 13, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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



Enrollment: 18
Study Start Date: January 2009
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

see above

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dislocated femoral fracture
  • ESIN osteosynthesis

Exclusion Criteria:

  • No given informed consent
  • Other osteosynthesis than ESIN
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  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: February 13, 2014
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 April 15, 2014