Tibial Fractures, External Fixation Pin Site Infection
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEExternal fixator
Tibia fracture (AO 41-43) treated with external fracture fixation (large external fixator)
Sponsors
AO Innovation Translation Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older * Diagnosis of tibial fracture (AO 41-43) * External fracture fixation with large external fixator * Capable of at least partial weight-bearing * Bone segment transport (if applicable) must be completed * 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 clinical investigation according to the Clinical Investigation Plan (CIP) * Signed and dated Ethics Committee (EC)
Exclusion criteria
* External fixation as temporary stabilization * Bone fragment compression * 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 women planning to conceive within the study period * Prisoner * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loading patterns | Up to 4 months | Average peak force per step |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activity | Up to 4 months | Patient activity measured as number of loading events per day |
| Healing | Up to 4 months | Expert opinion |
| Pain level | Up to 4 months | Numeric rating scale |
Countries
Germany
Outcome results
None listed