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

Primary Purpose

Femoral Fracture, Children

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
3-Nail-ESIN in femoral shaft fractures
Sponsored by
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Fracture focused on measuring Elastic stable intramedullary nailing, biomechanical testing, fracture, femur, treatment, children, adolescents

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Dislocated femoral fracture
  • ESIN osteosynthesis

Exclusion Criteria:

  • No given informed consent
  • Other osteosynthesis than ESIN

Sites / Locations

  • Department of Pediatric Surgery

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Femoral fracture, ESIN

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

misalignment
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

Full Information

First Posted
August 12, 2012
Last Updated
February 13, 2014
Sponsor
University of Luebeck
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1. Study Identification

Unique Protocol Identification Number
NCT01673048
Brief Title
Modification of ESIN-osteosynthesis in a Femoral Fracture Model and Its Transmission to Clinical Practice
Acronym
ESIN
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 Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Fracture, Children
Keywords
Elastic stable intramedullary nailing, biomechanical testing, fracture, femur, treatment, children, adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femoral fracture, ESIN
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
3-Nail-ESIN in femoral shaft fractures
Primary Outcome Measure Information:
Title
Intraoperative and postoperative complications
Description
All complications will be recorded: Intraoperative and postoperative complications, Re-Do operations
Time Frame
12 months
Secondary Outcome Measure Information:
Title
misalignment
Description
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°
Time Frame
12 m
Title
Pseudarthrosis
Time Frame
12 m
Other Pre-specified Outcome Measures:
Title
Limb discrepancy
Description
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
Time Frame
12 m

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dislocated femoral fracture ESIN osteosynthesis Exclusion Criteria: No given informed consent Other osteosynthesis than ESIN
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin M Kaiser, PD Dr. med.
Organizational Affiliation
University Luebeck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatric Surgery
City
Luebeck
ZIP/Postal Code
23538
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22529097
Citation
Kaiser MM, Zachert G, Wendlandt R, Eggert R, Stratmann C, Gros N, Schulze-Hessing M, Rapp M. Increasing stability by pre-bending the nails in elastic stable intramedullary nailing: a biomechanical analysis of a synthetic femoral spiral fracture model. J Bone Joint Surg Br. 2012 May;94(5):713-8. doi: 10.1302/0301-620X.94B5.28247.
Results Reference
background
PubMed Identifier
21923948
Citation
Kaiser MM, Zachert G, Wendlandt R, Rapp M, Eggert R, Stratmann C, Wessel LM, Schulz AP, Kienast BJ. Biomechanical analysis of a synthetic femoral spiral fracture model: Do end caps improve retrograde flexible intramedullary nail fixation? J Orthop Surg Res. 2011 Sep 18;6:46. doi: 10.1186/1749-799X-6-46.
Results Reference
background
PubMed Identifier
21345557
Citation
Kaiser MM, Wessel LM, Zachert G, Stratmann C, Eggert R, Gros N, Schulze-Hessing M, Kienast B, Rapp M. Biomechanical analysis of a synthetic femur spiral fracture model: Influence of different materials on the stiffness in flexible intramedullary nailing. Clin Biomech (Bristol, Avon). 2011 Jul;26(6):592-7. doi: 10.1016/j.clinbiomech.2011.01.012. Epub 2011 Feb 22.
Results Reference
background
PubMed Identifier
24397612
Citation
Kaiser MM, Stratmann C, Zachert G, Schulze-Hessing M, Gros N, Eggert R, Rapp M. Modification of elastic stable intramedullary nailing with a 3rd nail in a femoral spiral fracture model - results of biomechanical testing and a prospective clinical study. BMC Musculoskelet Disord. 2014 Jan 8;15:3. doi: 10.1186/1471-2474-15-3.
Results Reference
result
Links:
URL
http://www.kinderchirurgie.uni-luebeck.de/
Description
Department of Pediatric Surgery Luebeck

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

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