Fracture of Shaft of TibiaFRSmartFixNCT02094209
Focused Registry SmartFix
An observational study of Fracture of Shaft of Tibia, run by AO Clinical Investigation and Publishing Documentation at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Shaft of Tibia
- What is being tested?
- SmartFix
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Jul 2017
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Berufsgenossenschaftliche Unfallklinik
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Clinical Data Collection With a Novel Biofeedback Technology for Continuous Monitoring of Bone Healing
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.
Read the 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.
- Conditions
- Fracture of Shaft of Tibia
- Being tested
- SmartFix
- Keywords
- External Fixation, Tibial fracture, Fracture healing
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartFixDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Parameters derived from the AO Fracture Monitor during bone healing
AO Fracture Monitor:
- Mean deformation amplitude per 6 hours
- Mean deformation rate
- Number of load-cycles
- Histogram of patient activity (load intensity distribution)
Measured: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
Secondary outcomes (6)
Change in Pain during bone healing
Pain measured with visual analog scale (VAS)
Measured: Preoperative, Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery)
Change in weight-bearing during bone healing
Documentation of allowed weight-bearing
Measured: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery)
Repeated reference deformation at a load of 20 / 30 kg
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.
Measured: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery)
Patient information
- Patient demographics
- Comorbidities
Measured: Up to 4 weeks before surgery
Treatment information
- Fracture classification according to AO and Gustilo
- Reason for external fixator treatment
- Previous treatment related to current injury, if any
- Fixator configuration
Measured: Discharge
Development of the radiological healing assessment: RUST system
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.
Measured: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJan 2015
- Primary completionFeb 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Shaft of TibiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dankward Höntzsch, Professor, Principal investigator, Berufsgenossenschaftliche Unfallklinik Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094209
- Sponsor's protocol ID
- FRSmartFix
- Acronym
- FRSmartFix
- Status last verified
- Jan 2018
- First submitted
- 18 Mar 2014
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Data Collection With a Novel Biofeedback Technology for Continuous Monitoring of Bone Healing
- ClinicalTrials.gov ID
- NCT02094209
- Acronym / sponsor ID
- FRSmartFix / FRSmartFix
- Conditions
- Fracture of Shaft of Tibia
- Keywords
- External Fixation, Tibial fracture, Fracture healing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (8 listed)
- 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.:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartFixAO 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. | Device | – |
Primary outcome
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)
6 secondary outcomes
Change in Pain during bone healing
Time frame: Preoperative, Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery)
Change in weight-bearing during bone healing
Time frame: Discharge, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months (after surgery)
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)
Patient information
Time frame: Up to 4 weeks before surgery
Treatment information
Time frame: Discharge
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dankward Höntzsch, Professor principal investigator
Berufsgenossenschaftliche Unfallklinik Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture of Shaft of Tibia, run by AO Clinical Investigation and Publishing Documentation at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.