Evidence Based Development of a Novel Lateral Fibula Plate (VariAx Fibula) Using a Real CT Bone Data Based Optimization Process During Device Development

Schulz, Arndt P.; Reimers, Nils; Wipf, Felix; Vallotton, Michel; Bonaretti, Serena; Kozic, Nina; Reyes, Mauricio; Kienast, Benjamin J. (2012). Evidence Based Development of a Novel Lateral Fibula Plate (VariAx Fibula) Using a Real CT Bone Data Based Optimization Process During Device Development. Open orthopaedics journal, 6(1), pp. 1-7. Sharjah: Bentham Open 10.2174/1874325001206010001

[img]
Preview
Text
1TOORTHJ.pdf - Published Version
Available under License Creative Commons: Attribution-Noncommercial (CC-BY-NC).

Download (1MB) | Preview

Development of novel implants in orthopaedic trauma surgery is based on limited datasets of cadaver trials or artificial bone models. A method has been developed whereby implants can be constructed in an evidence based method founded on a large anatomic database consisting of more than 2.000 datasets of bones extracted from CT scans. The aim of this study was the development and clinical application of an anatomically pre-contoured plate for the treatment of distal fibular fractures based on the anatomical database. 48 Caucasian and Asian bone models (left and right) from the database were used for the preliminary optimization process and validation of the fibula plate. The implant was constructed to fit bilaterally in a lateral position of the fibula. Then a biomechanical comparison of the designed implant to the current gold standard in the treatment of distal fibular fractures (locking 1/3 tubular plate) was conducted. Finally, a clinical surveillance study to evaluate the grade of implant fit achieved was performed. The results showed that with a virtual anatomic database it was possible to design a fibula plate with an optimized fit for a large proportion of the population. Biomechanical testing showed the novel fibula plate to be superior to 1/3 tubular plates in 4-point bending tests. The clinical application showed a very high degree of primary implant fit. Only in a small minority of cases further intra-operative implant bending was necessary. Therefore, the goal to develop an implant for the treatment of distal fibular fractures based on the evidence of a large anatomical database could be attained. Biomechanical testing showed good results regarding the stability and the clinical application confirmed the high grade of anatomical fit.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute for Surgical Technology & Biomechanics ISTB [discontinued]

UniBE Contributor:

Bonaretti, Serena; Kozic, Nina and Reyes, Mauricio

Subjects:

500 Science > 570 Life sciences; biology
600 Technology > 610 Medicine & health

ISSN:

1874-3250

Publisher:

Bentham Open

Language:

English

Submitter:

Mauricio Antonio Reyes Aguirre

Date Deposited:

04 Oct 2013 14:30

Last Modified:

08 Jun 2016 10:29

Publisher DOI:

10.2174/1874325001206010001

BORIS DOI:

10.7892/boris.11481

URI:

https://boris.unibe.ch/id/eprint/11481 (FactScience: 217674)

Actions (login required)

Edit item Edit item
Provide Feedback