Clinical trial NCT02094209: Focused Registry SmartFix
Official title: Clinical Data Collection With a Novel Biofeedback Technology for Continuous Monitoring of Bone Healing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fracture of Shaft of Tibia
Keywords: External Fixation
Tibial fracture
Fracture healing
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2014-03-21
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: Patients with Tibia shaft fracture and external fracture fixation (AO large external fixator).

Patients capable of at least partial weight-bearing (or expected to do so in the course of healing).

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Change in Pain during bone healing
timeFrame: Preoperative, Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery)
measure: Change in weight-bearing during bone healing
timeFrame: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery)
measure: Repeated reference deformation at a load of 20 / 30 kg
timeFrame: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery)
measure: Patient information
timeFrame: Up to 4 weeks before surgery
measure: Treatment information
timeFrame: Discharge
measure: Development of the radiological healing assessment: RUST system
timeFrame: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery)
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Berufsgenossenschaftliche Unfallklinik
state: Baden Württemberg
Study officials:
affiliation: Berufsgenossenschaftliche Unfallklinik Tübingen
name: Dankward Höntzsch, Professor
role: PRINCIPAL_INVESTIGATOR
References: