Proximal Humeral FracturePHILOS-SIMNCT04056351
A Research Study to Understand and Predict the Failure of Shoulder Fracture Fixations Using Computer Simulations
A study testing Post-Operative (OP) Computer Tomography (CT), Questionnaires on patient activity and comorbidities and Grip strength measurement in people with Proximal Humeral Fracture, run by AO Research Institute Davos at 2 sites in 2 countries.
Trial summary
Fractures of the shoulder, the so-called proximal humeral fractures, can be treated with locking plates that have shown good results in clinical practice, but complications can occur. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Proximal Humeral Fracture
- What is being tested?
- Post-Operative (OP) Computer Tomography (CT), Questionnaires on patient activity and comorbidities and Grip strength measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Aug 2019to 31 Dec 2022
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥ 50 years
- Radiologically confirmed closed fracture of the proximal humerus and treatment within 10 days after injury
- Any displaced or unstable 3- or 4-part fracture of the proximal humerus except isolated displaced fractures of the greater or lesser tuberosity
- Completed primary fracture treatment with a PHILOS plate with or without cement augmentation of the screws
- Ability to understand the content of the patient information / informed consent form
- Willingness and ability to participate in the clinical investigation including imaging, activity tracking and other FU procedures
- Signed informed consent
Who cannot join
- Previous proximal humerus fracture on the ipsilateral side
- Splitting fracture of the humeral head or humeral head impression fracture
- Fibula grafting, bone block or any other non-cement augmentation of the PHILOS plate fixation
- Any serious fracture fixation issue (serious malreduction, too long screw or screw perforating through the humeral head, broken screw or implant) that are recognized on the immediate post-OP x-rays, independently of being re-operated or not
- Associated nerve or vessel injury
- Any severe systemic disease: class 4 - 5 of the American Society of Anesthesiologists (ASA) physical status classification
Show all 11Show fewer
- Recent history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment
- Prisoner
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
- Pregnancy
- Pacemaker
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Multicentric Prospective Interventional Study on Predicting the Mechanical Failure of PHILOS Plate Fixations in Older Adult Patients With Proximal Humerus Fractures Using Computer Simulations
Fractures of the shoulder, the so-called proximal humeral fractures, can be treated with locking plates that have shown good results in clinical practice, but complications can occur. In order to further improve the treatment of proximal humerus fractures and decrease the rate of fixation failures, further research is necessary. As a first step, the reasons for potential implant failures need to be understood.
This study has been initiated by scientists at the AO Research Institute Davos (ARI), Switzerland, which is the research center of the AO Foundation (www.aofoundation.org), an international non-profit organization led by surgeons specialized in fractures such as these. Researchers at the ARI have been developing a computational simulation tool to predict fixation failure and demonstrated its efficiency in laboratory conditions. This clinical study has been organised to validate this tool using patient data, by comparing the risk of mechanical failure predicted by the computer simulated model with the clinically observed fixation failure. In future, this computer simulation tool is expected to help surgeons to select the best fixation for a given patient and to develop improved implants.
Read the detailed description
Older adult patients with complex, displaced and/or unstable proximal humerus fractures treated with the PHILOS plate (DePuy Synthes Inc.) will be recruited. Detailed patient background information will be assessed. Surgical details will be acquired. Pre-, intra- and post-OP imaging data will be collected in frame of the standard treatment protocol. A post-OP CT scan, which is performed only occasionally as standard of care, will be acquired for all patients participating in this study. The de-identified medical images will be transferred via secure file transfer protocol (FTP) to the sponsor. Patient activity will be recorded in the first 6 post-OP weeks by means of two wearable activity trackers attached on the skin of the treated upper arm and the chest. The tracker containing the encoded data will be shipped back to the sponsor.
According to the standard post-OP protocols, follow-up (FU) examinations will be performed at 6 weeks, 3 months and 6 months after treatment. Additionally, another FU visit will be required at 3 weeks after surgery, where the activity trackers will be exchanged. FU radiographs during the standard of care visits will be compared with post-OP radiographs to determine if any mechanical failure has occurred.
Mechanical failure or no failure status of the fixation will be determined at 6 months following fracture treatment.
The patient-specific fixation failure risk will be prospectively predicted by means of computer simulations created from the pre-OP and post-OP CT images and surgical details. The prediction accuracy of the simulations will be evaluated by comparing the predicted failure risk with the clinically observed failure / no failure outcome. As a second approach, patient-specific shoulder activity (estimated based on patient pre-injury activity or measured directly post-operatively) will be incorporated into the simulations sequentially and its effect on the prediction accuracy will be evaluated.
The interventions in this study, i.e. the examinations that are beyond the current standard of care, will be i) the extra acquisition of the post-OP CT image in the cases that the treating surgeon is not requesting them, ii) the questionnaires on comorbidities and pre-injury activity, and grip strength measurements to estimate activity of the patient and iii) the post-OP activity measurement by means of wearable sensors.
- Conditions
- Proximal Humeral Fracture
- Being tested
- Post-Operative (OP) Computer Tomography (CT), Questionnaires on patient activity and comorbidities, Grip strength measurement, Non-invasive shoulder activity tracking usinig wearable sensors
- Keywords
- humerus, fracture, locking plate, PHILOS, fixation failure risk, computer simulation, patient activity tracking
- Medical subject headings
- Shoulder Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-Operative (OP) Computer Tomography (CT)Diagnostic test
Post-OP CT of the treated shoulder
Questionnaires on patient activity and comorbiditiesOther
- Shoulder activity scale (Marx)
- Parker Mobility Scale
- Barthel index
- Charlson Comorbidity Score
Grip strength measurementOther
Grip strength will be measured using a CE marked hydraulic hand dynamometer device.
Non-invasive shoulder activity tracking usinig wearable sensorsOther
Post-OP activity will be assessed via wearable CE-marked accelerometer sensors.
| Study group | Role | What they receive |
|---|---|---|
| Cohort of 50 enrolled patients | Other | The following visits will be performed: direct post-OP, 3 weeks, 6 weeks, 3 months and 6 months after surgery. Surgical details will be assessed from the surgical notes. Medical images will be collected according to the standard of care. A post-OP CT scan will also be acquired when the treating surgeon requests it as per standard of care, or additionally, as a study specific imaging procedure for the rest of the participants. Patient activity will be estimated based on various factors, including questionnaires on demographics, activity level, comorbidity score and contralateral grip strength. The actual post-OP shoulder activity will be measured by motion tracking by means of sensors attached to upper arm of the treated side and on the chest for 6 weeks and by grip strength assessed at the treated arm at week 6. Fixation failure status will be determined 6 months post-OP. Imaging and details regarding the fixation failure event will be sent to ARI. Receives: Diagnostic Test: Post-Operative (OP) Computer Tomography (CT); Other: Questionnaires on patient activity and comorbidities; Other: Grip strength measurement; Other: Non-invasive shoulder activity tracking usinig wearable sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fixation failure risk estimated from the structural capacity (strength) of the fixation
Fixation failure risk estimated from the structural capacity (strength) of the fixation will be predicted by the patient-specific computer simulation based on the collected:
- pre-OP CT images
- post-OP CT images
- surgical details.
Measured: 6 months post-op
Clinical occurrence of radiographically confirmed mechanical fixation failure
Clinical occurrence of radiographically confirmed mechanical fixation failure within 6 months after PHILOS plate treatment (failure / no failure status).
Mechanical failures are defined as:
- loss of reduction (≥ 15° increase of varus malposition between the immediate post-OP position and FU radiograph, and/or relative change (5 mm) of greater or lesser tuberosity compared to the immediate post-OP position)
- cut-out failure (≥ 5 mm distal displacement of the humeral head fragment between immediate post-OP and FU)
- head impaction (≥ 5 mm difference in outer plate edge and tangent of humeral head between immediate post-OP and FU), and/or
- secondary screw perforation (Perforation of one or more screws through the humeral head on the FU radiograph (and lack of screw perforation on the intra- or post-OP radiograph based on a direct post-OP AP and axial radiographs))
Measured: 6 months post-op
Secondary outcomes (2)
Fixation failure risk predicted by the simulation when activity information is included in the model
Fixation failure risk predicted by the simulation when activity information is included in the model, estimated based on categorization of the participants in low, average and high pre-injury activity level from the following questionnaires and assessments:
- Demographics
- Age (in years)
- Gender
- Height (in meters)
- Weight (in kilograms)
- Residential status
- Dominant arm
- Side and type of injury
- Grip strength assessed at the uninjured side
- Shoulder activity scale (Marx)
- Parker Mobility Scale
- Barthel index
- Charlson Comorbidity Score
Measured: 4 days post-op
Fixation failure risk predicted by the simulation when actual post-OP shoulder activity information is included in the model
Fixation failure risk predicted by the simulation when actual post-OP shoulder activity information is included in the model, based on the following data:
- Directly measured post-OP shoulder activity (range of motion, frequency, velocity) (up to 6 weeks)
- Grip strength assessed at the treated side (6 weeks)
Measured: 6 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start2 Aug 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Proximal Humeral FractureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Research Institute Davos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Varga, PhD, Principal investigator, AO Research Institute Davos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056351
- Sponsor's protocol ID
- AR2018_01
- Acronym
- PHILOS-SIM
- Status last verified
- Jan 2023
- First submitted
- 12 Aug 2019
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Varga P, Inzana JA, Gueorguiev B, Sudkamp NP, Windolf M. Validated computational framework for efficient systematic evaluation of osteoporotic fracture fixation in the proximal humerus. Med Eng Phys. 2018 Jul;57:29-39. doi: 10.1016/j.medengphy.2018.04.011. Epub 2018 May 1.
PubMed 29728330Varga P, Grunwald L, Inzana JA, Windolf M. Fatigue failure of plated osteoporotic proximal humerus fractures is predicted by the strain around the proximal screws. J Mech Behav Biomed Mater. 2017 Nov;75:68-74. doi: 10.1016/j.jmbbm.2017.07.004. Epub 2017 Jul 4.
PubMed 28697401
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Prospective Interventional Study on Predicting the Mechanical Failure of PHILOS Plate Fixations in Older Adult Patients With Proximal Humerus Fractures Using Computer Simulations
- ClinicalTrials.gov ID
- NCT04056351
- Acronym / sponsor ID
- PHILOS-SIM / AR2018_01
- Conditions
- Proximal Humeral Fracture
- Keywords
- humerus, fracture, locking plate, PHILOS, fixation failure risk, computer simulation, patient activity tracking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- AO Research Institute DavosUniversity, hospital or other
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 Aug 2019 (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.
Fractures of the shoulder, the so-called proximal humeral fractures, can be treated with locking plates that have shown good results in clinical practice, but complications can occur. In order to further improve the treatment of proximal humerus fractures and decrease the rate of fixation failures, further research is necessary. As a first step, the reasons for potential implant failures need to be understood.
This study has been initiated by scientists at the AO Research Institute Davos (ARI), Switzerland, which is the research center of the AO Foundation (www.aofoundation.org), an international non-profit organization led by surgeons specialized in fractures such as these. Researchers at the ARI have been developing a computational simulation tool to predict fixation failure and demonstrated its efficiency in laboratory conditions. This clinical study has been organised to validate this tool using patient data, by comparing the risk of mechanical failure predicted by the computer simulated model with the clinically observed fixation failure. In future, this computer simulation tool is expected to help surgeons to select the best fixation for a given patient and to develop improved implants.
Detailed description
Older adult patients with complex, displaced and/or unstable proximal humerus fractures treated with the PHILOS plate (DePuy Synthes Inc.) will be recruited. Detailed patient background information will be assessed. Surgical details will be acquired. Pre-, intra- and post-OP imaging data will be collected in frame of the standard treatment protocol. A post-OP CT scan, which is performed only occasionally as standard of care, will be acquired for all patients participating in this study. The de-identified medical images will be transferred via secure file transfer protocol (FTP) to the sponsor. Patient activity will be recorded in the first 6 post-OP weeks by means of two wearable activity trackers attached on the skin of the treated upper arm and the chest. The tracker containing the encoded data will be shipped back to the sponsor.
According to the standard post-OP protocols, follow-up (FU) examinations will be performed at 6 weeks, 3 months and 6 months after treatment. Additionally, another FU visit will be required at 3 weeks after surgery, where the activity trackers will be exchanged. FU radiographs during the standard of care visits will be compared with post-OP radiographs to determine if any mechanical failure has occurred.
Mechanical failure or no failure status of the fixation will be determined at 6 months following fracture treatment.
The patient-specific fixation failure risk will be prospectively predicted by means of computer simulations created from the pre-OP and post-OP CT images and surgical details. The prediction accuracy of the simulations will be evaluated by comparing the predicted failure risk with the clinically observed failure / no failure outcome. As a second approach, patient-specific shoulder activity (estimated based on patient pre-injury activity or measured directly post-operatively) will be incorporated into the simulations sequentially and its effect on the prediction accuracy will be evaluated.
The interventions in this study, i.e. the examinations that are beyond the current standard of care, will be i) the extra acquisition of the post-OP CT image in the cases that the treating surgeon is not requesting them, ii) the questionnaires on comorbidities and pre-injury activity, and grip strength measurements to estimate activity of the patient and iii) the post-OP activity measurement by means of wearable sensors.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of 50 enrolled patients | Other | Diagnostic Test: Post-Operative (OP) Computer Tomography (CT), Other: Questionnaires on patient activity and comorbidities, Other: Grip strength measurement, Other: Non-invasive shoulder activity tracking usinig wearable sensorsThe following visits will be performed: direct post-OP, 3 weeks, 6 weeks, 3 months and 6 months after surgery. Surgical details will be assessed from the surgical notes. Medical images will be collected according to the standard of care. A post-OP CT scan will also be acquired when the treating surgeon requests it as per standard of care, or additionally, as a study specific imaging procedure for the rest of the participants. Patient activity will be estimated based on various factors, including questionnaires on demographics, activity level, comorbidity score and contralateral grip strength. The actual post-OP shoulder activity will be measured by motion tracking by means of sensors attached to upper arm of the treated side and on the chest for 6 weeks and by grip strength assessed at the treated arm at week 6. Fixation failure status will be determined 6 months post-OP. Imaging and details regarding the fixation failure event will be sent to ARI. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age≥ 50 years
- Radiologically confirmed closed fracture of the proximal humerus and treatment within 10 days after injury
- Any displaced or unstable 3- or 4-part fracture of the proximal humerus except isolated displaced fractures of the greater or lesser tuberosity
- Completed primary fracture treatment with a PHILOS plate with or without cement augmentation of the screws
- Ability to understand the content of the patient information / informed consent form
Key exclusion criteria (11 listed)
- Previous proximal humerus fracture on the ipsilateral side
- Splitting fracture of the humeral head or humeral head impression fracture
- Fibula grafting, bone block or any other non-cement augmentation of the PHILOS plate fixation
- Any serious fracture fixation issue (serious malreduction, too long screw or screw perforating through the humeral head, broken screw or implant) that are recognized on the immediate post-OP x-rays, independently of being re-operated or not
- Associated nerve or vessel injury
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 |
|---|---|---|
| Post-Operative (OP) Computer Tomography (CT)Post-OP CT of the treated shoulder | Diagnostic test | Cohort of 50 enrolled patients |
| Questionnaires on patient activity and comorbidities* Shoulder activity scale (Marx) * Parker Mobility Scale * Barthel index * Charlson Comorbidity Score | Other | Cohort of 50 enrolled patients |
| Grip strength measurementGrip strength will be measured using a CE marked hydraulic hand dynamometer device. | Other | Cohort of 50 enrolled patients |
| Non-invasive shoulder activity tracking usinig wearable sensorsPost-OP activity will be assessed via wearable CE-marked accelerometer sensors. | Other | Cohort of 50 enrolled patients |
Primary outcome
Fixation failure risk estimated from the structural capacity (strength) of the fixation
Time frame: 6 months post-op
Fixation failure risk estimated from the structural capacity (strength) of the fixation will be predicted by the patient-specific computer simulation based on the collected: * pre-OP CT images * post-OP CT images * surgical details.
Clinical occurrence of radiographically confirmed mechanical fixation failure
Time frame: 6 months post-op
Clinical occurrence of radiographically confirmed mechanical fixation failure within 6 months after PHILOS plate treatment (failure / no failure status). Mechanical failures are defined as: * loss of reduction (≥ 15° increase of varus malposition between the immediate post-OP position and FU radiograph, and/or relative change (5 mm) of greater or lesser tuberosity compared to the immediate post-OP position) * cut-out failure (≥ 5 mm distal displacement of the humeral head fragment between immediate post-OP and FU) * head impaction (≥ 5 mm difference in outer plate edge and tangent of humeral head between immediate post-OP and FU), and/or * secondary screw perforation (Perforation of one or more screws through the humeral head on the FU radiograph (and lack of screw perforation on the intra- or post-OP radiograph based on a direct post-OP AP and axial radiographs))
2 secondary outcomes
Fixation failure risk predicted by the simulation when activity information is included in the model
Time frame: 4 days post-op
Fixation failure risk predicted by the simulation when actual post-OP shoulder activity information is included in the model
Time frame: 6 weeks post-op
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 1 Feb 2023.
- Background: PubMed 29728330Varga P, Inzana JA, Gueorguiev B, Sudkamp NP, Windolf M. Validated computational framework for efficient systematic evaluation of osteoporotic fracture fixation in the proximal humerus. Med Eng Phys. 2018 Jul;57:29-39. doi: 10.1016/j.medengphy.2018.04.011. Epub 2018 May 1.
- Background: PubMed 28697401Varga P, Grunwald L, Inzana JA, Windolf M. Fatigue failure of plated osteoporotic proximal humerus fractures is predicted by the strain around the proximal screws. J Mech Behav Biomed Mater. 2017 Nov;75:68-74. doi: 10.1016/j.jmbbm.2017.07.004. Epub 2017 Jul 4.
- Individual participant dataSharing planned: No
Related trials for Proximal Humeral Fracture
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
Not yet recruiting
Study on Outcomes of Proximal Humerus Fractures
Proximal Humerus Fracture
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
Enrolling by invitationObservational study
OsseoFit Stemless Shoulder System (Anatomic)
Shoulder Injuries, Shoulder Pain
Active, not recruitingObservational study
Affixus Natural Nail System Humeral Nail PMCF
Humeral Fractures, Proximal, Humeral Fractures
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.
Peter Varga, PhD principal investigator
AO Research Institute Davos
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-Operative (OP) Computer Tomography (CT), Questionnaires on patient activity and comorbidities and Grip strength measurement in people with Proximal Humeral Fracture, run by AO Research Institute Davos at 2 sites in 2 countries.
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 7 inclusion and 11 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 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Belgium. 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?
Fixation failure risk estimated from the structural capacity (strength) of the fixation (time frame: 6 months post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04056351, which also lists 2 linked publications.
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 1 Feb 2023.