Modification of ESIN-osteosynthesis in a Femoral Fracture Model and Its Transmission to Clinical Practice
NCT ID: NCT01673048
Last Updated: 2014-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2009-01-31
2012-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
3-Nail-ESIN in femoral shaft fractures
Interventions
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3-Nail-ESIN in femoral shaft fractures
Eligibility Criteria
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Inclusion Criteria
* ESIN osteosynthesis
Exclusion Criteria
* Other osteosynthesis than ESIN
3 Years
17 Years
ALL
No
Sponsors
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University of Luebeck
OTHER
Responsible Party
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Martin M Kaiser
Consultant
Principal Investigators
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Martin M Kaiser, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Luebeck
Locations
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Department of Pediatric Surgery
Lübeck, , Germany
Countries
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References
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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.
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.
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.
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.
Related Links
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Department of Pediatric Surgery Luebeck
Other Identifiers
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3ESINFemur
Identifier Type: -
Identifier Source: org_study_id
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