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Biomechanical Characterization of Human Soft Tissues Using Indentation and Tensile Testing
07:07

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Published on: December 13, 2016

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Sample size considerations in soft tissue biomechanics.

Niels Hammer1, Benjamin Ondruschka2, Andrea Berghold3

  • 1Division of Macroscopic and Clinical Anatomy, Gottfried Schatz Research Center, Medical University of Graz, Graz, Austria; Department of Orthopedic and Trauma Surgery, University of Leipzig, Leipzig, Germany; Division of Biomechatronics, Fraunhofer Institute for Machine Tools and Forming Technology Dresden, Germany.

Acta Biomaterialia
|July 30, 2023
PubMed
Summary

Determining accurate material properties for human tissues like dura and scalp requires a specific minimum sample size. Stable estimations for mechanical properties are achievable with fewer than 30 samples under certain conditions.

Keywords:
Biomechanical propertyConformityCorridor of stabilityDura materHeadHuman scalp skinMorpho-mechanical parameterNeurocraniumSample size estimationTolerance levelVariation

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Area of Science:

  • Biomedical Engineering
  • Materials Science
  • Biomechanics

Background:

  • Biomechanical experiments are crucial for understanding the relationship between tissue structure and mechanical behavior.
  • Accurate material properties of biological tissues are essential for applications in surgical repair, tissue engineering, and computational modeling.
  • The minimum number of samples required for reliable material property estimation can vary significantly between different tissue types.

Purpose of the Study:

  • To determine the minimum sample sizes necessary for stable estimation of material properties in distinct human soft tissues.
  • To investigate the influence of tolerance levels and conformity on the required sample size for accurate biomechanical data.
  • To establish guidelines for sample size selection in biomechanical studies involving human tissues.

Main Methods:

  • Biomechanical testing was performed on human dura mater and scalp skin to obtain stress-strain properties.
  • A simulation study was conducted, sequentially drawing 1,000 random samples to assess estimator stability.
  • Point estimations for mean, median, and coefficient of variation were analyzed within defined tolerance levels and conformity criteria.

Main Results:

  • Stable estimations for mean and median material properties were achieved with sample sizes below 30 for both scalp skin and dura mater at a ±20% tolerance and 80% conformity.
  • Lower tolerance levels or higher conformity requirements significantly increased the necessary sample size.
  • Achieving conformity for the coefficient of variation proved challenging, indicating parameter type influences data stability.

Conclusions:

  • A sample size of fewer than 30 specimens can yield stable estimations of mean and median mechanical properties for human dura and scalp under specific conditions.
  • Higher accuracy demands substantially larger sample sizes, particularly for properties like the coefficient of variation.
  • Tissue-specific sample size requirements must be considered to ensure the reliability of biomechanical data for research and clinical applications.