Overview

This trial is active, not recruiting.

Condition fracture of shaft of tibia
Treatment smartfix
Sponsor AO Clinical Investigation and Documentation
Start date January 2015
End date July 2017
Trial size 10 participants
Trial identifier NCT02094209, FRSmartFix

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Changes in Parameters derived from the AO Fracture Monitor during bone healing
time frame: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months

Secondary Outcomes

Measure
Change in Pain during bone healing
time frame: Preoperative, Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery)
Change in weight-bearing during bone healing
time frame: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery)
Repeated reference deformation at a load of 20 / 30 kg
time frame: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery)
Patient information
time frame: Up to 4 weeks before surgery
Treatment information
time frame: Discharge
Development of the radiological healing assessment: RUST system
time frame: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Clinical Data Collection With a Novel Biofeedback Technology for Continuous Monitoring of Bone Healing
Principal investigator Dankward Höntzsch, Professor
Description Maturation of fracture callus leads to unloading of the fracture fixation hardware due to an increased load-share of the repair tissue. A novel data logger device (AO Fracture Monitor) continuously measures the decline in fixation hardware deflection under physiological loading as indirect indicator for the healing progress. Parameters obtained from the data logger device carry potential to significantly improve the assessment of fracture healing in the future. Meaningful interpretation of measurements requires a set of clinical reference data. 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 4 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. Data is collected from the AO Fracture Monitor at follow-up visits of the patient by wireless data transfer. Together with additional variables such as treatment details, fracture healing and pain reported by the patient, the collected data is used to build up a database. Data from the AO Fracture Monitor will be correlated with patient data to investigate the relevance and reliability of the data derived from the AO Fracture Monitor. In this phase, the study does not imply changes on the operational treatment, nor does it allow for therapeutic consequences based on the derived data.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by AO Clinical Investigation and Documentation.