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Clinical Validation

Clinical assessment of the usability and applicability of the BoneGainer

Non-randomized comparative usability pilot study (2025) assessing ergonomics, efficiency, effectiveness, and user satisfaction in comparison to an established reference instrument.

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+47%
Ergonomics
+39%
Efficiency
+34%
Effectiveness
+34%
User Satisfaction
r = 0.86 Cohen effect size
Study Overview

Study parameters at a glance

The study was conducted under standardized conditions to assess the usability and application characteristics of the BoneGainer.

The investigation was conducted as a non-randomized comparative usability pilot study. Its objective was to assess relevant application parameters in a direct comparison between BoneGainer® and an established reference instrument. The evaluation was based on standardized application scenarios and a structured questionnaire.

Participants

16 participants from the fields of oral surgery, dentistry, and OMFS training.

Use of both instruments

Standardized clinical simulation conducted on human cadaveric models.

25 assessment parameters

Captured via a structured 25-item Likert scale (1–5).

Statistical analysis

Paired Wilcoxon test to examine the differences.

Results comparison

Comparison of the ratings between BoneGainer® and the reference instrument.

Results

Significant improvements across all examined categories

The BoneGainer achieved statistically significantly better ratings than the reference instrument in all main categories examined.

F-01
+47% Ergonomics

Improved Ergonomic Performance

BoneGainer demonstrated significantly improved ergonomic performance, reducing operator fatigue and enabling more controlled surgical movements throughout the procedure.

F-02
+34% Effectiveness

Consistent Cutting Behavior

The replaceable blade mechanism maintained consistent cutting behavior throughout procedures, eliminating the performance degradation seen with conventional instruments.

F-03
+34% User Satisfaction

Universal User Satisfaction

Increased user satisfaction was observed across all experience levels — from trainees to experienced oral surgeons — confirming broad clinical applicability.

F-04
r = 0.82–0.86 Cohen effect size

Very Large Clinical Relevance

Cohen effect size values of r = 0.82 – 0.86 confirm very large clinical relevance per established statistical classification, substantiating the practical significance of the findings.

Study Limitations

Contextualizing the results

The investigation was conducted as a non-randomized usability pilot study and served to assess usability and application characteristics under standardized conditions.

The results provide valuable insights into user experience and the handling of the instrument. Further investigations may provide additional insights into its application across different clinical scenarios.

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Scientific Conclusion

Summary of the study results

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The results of the study show statistically significant improvements in several application parameters examined, compared to the reference instrument. The differences were particularly pronounced in the areas of ergonomics, workflow efficiency, and user satisfaction.

Full Study Report

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Get access to the complete study report including detailed methodology, statistical analysis, and a full presentation of the results.

Clinical study report

BoneGainer® Clinical Usability Pilot Study

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