Clinical trial NCT03166267: Real Life Weight Bearing After Tibial Fractures
Official title: A Prospective Case Series Study to Monitor Healing Progression and Real Life Weight Bearing After Tibial Fracture Using Smart Biofeedback Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tibial Fractures
External Fixation Pin Site Infection
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients from the participating clinic are invited to participate in the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Loading patterns
timeFrame: Up to 4 months
Secondary outcomes:
measure: Activity
timeFrame: Up to 4 months
measure: Healing
timeFrame: Up to 4 months
measure: Pain level
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: BGU Tübingen
Study officials:
affiliation: BGU Tübingen
name: Stefan Döbele, MD
role: PRINCIPAL_INVESTIGATOR
References: