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Focused Registry SmartFix (FRSmartFix)

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ClinicalTrials.gov Identifier: NCT02094209
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
AO Innovation Translation Center ( AO Clinical Investigation and Publishing Documentation )

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.

Condition or disease Intervention/treatment
Fracture of Shaft of Tibia Device: SmartFix

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Clinical Data Collection With a Novel Biofeedback Technology for Continuous Monitoring of Bone Healing
Actual Study Start Date : January 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures


Intervention Details:
  • Device: SmartFix
    AO Fracture Monitor attached postoperatively 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.


Primary Outcome Measures :
  1. 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 ]

    AO Fracture Monitor:

    • Mean deformation amplitude per 6 hours
    • Mean deformation rate
    • Number of load-cycles
    • Histogram of patient activity (load intensity distribution)


Secondary Outcome Measures :
  1. Change in Pain during bone healing [ Time Frame: Preoperative, Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery) ]
    Pain measured with visual analog scale (VAS)

  2. Change in weight-bearing during bone healing [ Time Frame: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery) ]
    Documentation of allowed weight-bearing

  3. 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) ]
    Two reference deformation values are measured under a load 20 kg and 30 kg respectively. The patient steps with his injured leg on a bathroom scale and loads it first with the reference load of 20 kg. The investigator then starts the measurement of the corresponding deformation value. After an acoustic signal indicates the end of the measurement, the procedure is repeated with a reference load of 30 kg. If the patient is not able to put the required load on his leg (e.g. due to pain), the reference value should be measured at a lower load with a note of the actually applied load in the patient record.

  4. Patient information [ Time Frame: Up to 4 weeks before surgery ]
    • Patient demographics
    • Comorbidities

  5. Treatment information [ Time Frame: Discharge ]
    • Fracture classification according to AO and Gustilo
    • Reason for external fixator treatment
    • Previous treatment related to current injury, if any
    • Fixator configuration

  6. 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) ]

    The Radiographic Union Score for Tibial fractures (RUST score) is a reliable score to assess the healing of tibial fractures. Each of the four cortices (anterior, posterior, medial and lateral) is given a value from 1 to 3, depending on the presence of a callus and the visibility of the fracture line. The sum of the individual cortical scores results in a RUST value between 4 (definitely not healed) to 12 (definitely healed).

    To investigate, whether patient activity as measured by the AO Fracture Monitor correlate with the radiological assessed course of healing.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094209


Locations
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Germany
Berufsgenossenschaftliche Unfallklinik
Tübingen, Baden Württemberg, Germany, 72076
Sponsors and Collaborators
AO Clinical Investigation and Publishing Documentation
Investigators
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Principal Investigator: Dankward Höntzsch, Professor Berufsgenossenschaftliche Unfallklinik Tübingen
Additional Information:

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Responsible Party: AO Clinical Investigation and Publishing Documentation
ClinicalTrials.gov Identifier: NCT02094209    
Other Study ID Numbers: FRSmartFix
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: January 2018
Keywords provided by AO Innovation Translation Center ( AO Clinical Investigation and Publishing Documentation ):
External Fixation
Tibial fracture
Fracture healing
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries