CompletedNot Applicable

Focused Registry SmartFix

Germany10 participantsStarted 2015-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years and older * Diagnosis of Femoral or tibial fracture (AO 41-43) * External fracture fixation with AO large external fixator * Capable of at least partial weight-bearing * Informed consent obtained, i.e.: * Ability to understand the content of the patient information/Informed Consent Form (ICF) * Willingness and ability to participate in the Focused Registry according to the Registry Plan (RP) * Signed and dated Ethics Committee (EC) approved written informed consent Exclusion Criteria: Preoperative exclusion criteria: * External fixation as temporary stabilization * Joint-bridging external fixation * Any not medically managed severe systemic disease * Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment * Pregnancy or nursing mother * Emergency patient * Prisoner * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

What they're measuring

Changes in Parameters derived from the AO Fracture Monitor during bone healing

Timeframe: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months

Trial details

NCT IDNCT02094209

SponsorAO Clinical Investigation and Publishing Documentation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-02