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Focused Registry SmartFix

NCT02094209 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2020-08-12

No results posted yet for this study

Summary

20 patients having received an AO large external fixator at the tibia will be equipped with a data logger device (AO Fracture Monitor) attached post-operation to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to weight bearing for up to 6 months by means of a strain gauge. Several parameters are calculated from the recorded change in the strain signal and are stored at a regular interval.

Conditions

  • Fracture of Shaft of Tibia

Interventions

DEVICE

SmartFix

AO Fracture Monitor attached postoperatively to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to weight bearing for up to 4 months by means of a strain gauge.

Sponsors & Collaborators

  • AO Clinical Investigation and Publishing Documentation

    lead OTHER

Principal Investigators

  • Dankward Höntzsch, Professor · Berufsgenossenschaftliche Unfallklinik Tübingen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-02-28
Completion
2017-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02094209 on ClinicalTrials.gov