An observational study in Tibial Fractures and External Fixation Pin Site Infection, sponsored by AO Innovation Translation Center. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-06.
Sponsored by AO Innovation Translation Center · Observational
In this prospective case series patients with a tibial fracture are monitored with smart biofeedback systems to document the healing progression and real life weight.
Ten patients treated with a large external fixator after tibial fracture will be enrolled for this prospective case series.
Patients will be equipped with the AO Fracture Monitor (a data logger device) attached post-operatively to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to normal weight bearing for up to 12 months by means of a strain gauge. The strain signal is processed on-board and several parameters related to the loading characteristics of the fracture are stored.
Simultaneously, patients will be equipped with a fully integrated sensor insole (OpenGo Insole, Moticon GmbH, München). This product offers long-term weight bearing data (recording and storage) and allows non-invasive documentation of real life loading in patients without affecting the daily life activity of the patient. Recording of weight-bearing data will be obtained for a maximum of 4 months.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 10 is below the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →AO Innovation Translation Center is the lead sponsor of 31 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All eligible patients from the participating clinic are invited to participate in the study.
Informed consent obtained, i.e.:
Exclusion Criteria:
Tibia fracture (AO 41-43) treated with external fracture fixation (large external fixator)
Loading patterns
Average peak force per step
Time frame: Up to 4 months
Activity
Patient activity measured as number of loading events per day
Time frame: Up to 4 months
Healing
Expert opinion
Time frame: Up to 4 months
Pain level
Numeric rating scale
Time frame: Up to 4 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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AO Innovation Translation Center