Tibial FracturesNCT03166267
Real Life Weight Bearing After Tibial Fractures
An observational study of Tibial Fractures and External Fixation Pin Site Infection, run by AO Innovation Translation Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Fractures, External Fixation Pin Site Infection
- What is being tested?
- External fixator
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 24 May 2018to 24 Feb 2021
- 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: All eligible patients from the participating clinic are invited to participate in the study.
Who may be able to join
- 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.:
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Case Series Study to Monitor Healing Progression and Real Life Weight Bearing After Tibial Fracture Using Smart Biofeedback Systems
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.
Read the 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.
- Being tested
- External fixator
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External fixatorDevice
Tibia fracture (AO 41-43) treated with external fracture fixation (large external fixator)
What is being measured
The primary outcome is the main question the study is designed to answer.
Loading patterns
Average peak force per step
Measured: Up to 4 months
Secondary outcomes (3)
Activity
Patient activity measured as number of loading events per day
Measured: Up to 4 months
Healing
Expert opinion
Measured: Up to 4 months
Pain level
Numeric rating scale
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start24 May 2018
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FracturesStudies 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)
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Döbele, MD, Principal investigator, BGU Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166267
- Sponsor's protocol ID
- SmartFix II - Moticon
- Status last verified
- Oct 2020
- First submitted
- 22 May 2017
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Case Series Study to Monitor Healing Progression and Real Life Weight Bearing After Tibial Fracture Using Smart Biofeedback Systems
- ClinicalTrials.gov ID
- NCT03166267
- Acronym / sponsor ID
- SmartFix II - Moticon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- 24 May 2018 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 25 May 2017 (actual)
- 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients from the participating clinic are invited to participate in the study.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| External fixatorTibia fracture (AO 41-43) treated with external fracture fixation (large external fixator) | Device | – |
Primary outcome
Loading patterns
Time frame: Up to 4 months
Average peak force per step
3 secondary outcomes
Activity
Time frame: Up to 4 months
Healing
Time frame: Up to 4 months
Pain level
Time frame: Up to 4 months
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 6 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Stefan Döbele, MD principal investigator
BGU 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 Tibial Fractures and External Fixation Pin Site Infection, run by AO Innovation Translation Center 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 9 inclusion and 8 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 6 Jul 2021. 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?
Loading patterns (time frame: Up to 4 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 6 Jul 2021.