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

NCT01673048 | Completed

• 1 other identifier: 3ESINFemur
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Fracture; Children

Keywords

Elastic stable intramedullary nailing; biomechanical testing; fracture; femur; treatment; children; adolescents

Outcome Measures

Primary Outcomes (1)

• Intraoperative and postoperative complications

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

  12 months

Secondary Outcomes (2)

• misalignment

  12 m

• Pseudarthrosis

  12 m

Other Outcomes (1)

• Limb discrepancy

  12 m

Study Arms (1)

Femoral fracture, ESIN

ACTIVE COMPARATOR

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

Interventions

3-Nail-ESIN in femoral shaft fractures PROCEDURE

Femoral fracture, ESIN

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Dislocated femoral fracture
• ESIN osteosynthesis

You may not qualify if:

• No given informed consent
• Other osteosynthesis than ESIN

Sponsors & Collaborators

• University of Luebeck: lead

Study Sites (1)

Department of Pediatric Surgery

Lübeck, 23538, Germany

Location

Related Publications (4)

• 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.

  PMID: 22529097 BACKGROUND

• 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.

  PMID: 21923948 BACKGROUND

• 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). 2011 Jul;26(6):592-7. doi: 10.1016/j.clinbiomech.2011.01.012. Epub 2011 Feb 22.

  PMID: 21345557 BACKGROUND

• 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.

  PMID: 24397612 RESULT

Related Links

• Department of Pediatric Surgery Luebeck

MeSH Terms

Conditions

Femoral Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries; Leg Injuries

Study Officials

• Martin M Kaiser, PD Dr. med.

  University Luebeck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: August 12, 2012
• First Posted: August 27, 2012
• Study Start: January 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

DE (1)