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

Children Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673048
• Other study ID #: 3ESINFemur
• Status: Completed
• Phase: N/A
• First received: August 12, 2012
• Last updated: February 13, 2014
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 17 Years

Eligibility

Inclusion Criteria:

• Dislocated femoral fracture

• ESIN osteosynthesis

Exclusion Criteria:

• No given informed consent

• Other osteosynthesis than ESIN

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Children
• Femoral Fracture
• Femoral Fractures
• Fractures, Bone

Intervention

Procedure:
• 3-Nail-ESIN in femoral shaft fractures

Locations

Country	Name	City	State
Germany	Department of Pediatric Surgery	Luebeck

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. B — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Limb discrepancy	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	12 m	No
Primary	Intraoperative and postoperative complications	All complications will be recorded: Intraoperative and postoperative complications, Re-Do operations	12 months	No
Secondary	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°	12 m	No
Secondary	Pseudarthrosis		12 m	No

External Links

•   Department of Pediatric Surgery Luebeck