Proximal Humeral FractureNCT03427112
Assessment of the Surgical Handling and Performance of the X-ray-based Tracking and Navigation System "Xin1 Humerus System" Evaluated From 10 Proximal Humerus Plate Fixations
An observational study of Proximal Humeral Fracture, run by AO Research Institute Davos at 1 site in Belgium.
Trial summary
Xin1 Humerus system is an X-ray-based tracking and navigation system designed to calculate the plate position and all required proximal screw lengths for proximal humerus plate fixation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humeral Fracture
- What is being tested?
- Xin1 Humerus System
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Apr 2017to 6 Mar 2020
- How long will I take part?
- 1 Day
- 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
- Adult, Older adult
Study population: Patients with proximal humerus fracture which are transferred to the Dpt. Traumatologie, ZU Leuven, will be recruited during diagnosis and indication.
Who may be able to join
- Age 18 years and older
- Diagnosis of proximal humerus fracture
- Indicated for plate fixation osteosynthesis
- Informed consent obtained
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation of the Xin1 Humerus System
Xin1 Humerus system is an X-ray-based tracking and navigation system designed to calculate the plate position and all required proximal screw lengths for proximal humerus plate fixation. The aim is to validate the system performance in a clinical context and test the surgical handling of the Xin1 marker in a hospital environment. 10 adults having sustained a proximal humerus fracture and are indicated for plate fixation osteosynthesis will be provided intraoperatively with the Xin1 marker. The system performance is evaluated retrospectively by post-processing the intraoperative X-ray images after surgery
Read the detailed description
Treatment of fragility fractures at the proximal Humerus still remains a major challenge in trauma surgery. Several factors such as highly compromised bone mass, complex loading conditions, multi-fragment fractures, absent bony support and limited surgical access render the fixation particularly complex. Especially in elderly osteoporotic patients, implant position and fixation plays a key role for a successful outcome. Nowadays, complication rates of plate and screw fixation systems in the proximal Humerus region under complex fracture patterns are reported to range between 28% and 79%. A significant portion of these cases can be attributed to implant mal-placement. Particularly, when screws are too short and the subchondral bone stock is missed out, screw anchorage is significantly compromised. On the other hand, if screws are too long they might penetrate into the joint with devastating consequences. Adequate selection of screw length is hence of utmost importance. However, the particular anatomical situation challenges the determination procedure which results in prolonged operational time and increased X-ray exposure. New strategies are needed to simply, reliably and accurately fix proximal humeral fractures with plate-screw constructs. Xin1 is an X-ray-based tracking and navigation system designed to simplify a variety of surgical applications. For the Humerus application the position in space of the proximal Humerus plate is calculated in such manner, which then can be related to the position of the humeral head as derived from an image pair. All required proximal screw lengths are determined from these two radiographs. From ex-vivo evaluation the Xin1 Humerus System has proven its value in terms of accuracy increase as well as time and X-ray reduction. A clear potential for improving clinical practice is therefore apparent. The consequent next step is a first clinical phase verifying the basic function of the Xin1 system in a clinical context and investigating the surgical handling in a hospital environment.
This clinical trial aims to
- validate the Xin1 Humerus system performance in a clinical context.
- test the surgical handling of the Xin1 marker in a hospital environment.
There is no additional time effort required from the patient. All capacitated adults having sustained a proximal humerus fracture indicated for plate fixation osteosynthesis can be included in the study. The study is limited to 10 patients and 1 year. To minimize the patient risk it is suggested in this first study phase to entirely eliminate the system feedback to the surgeon during surgery. The system performance is evaluated retrospectively by post-processing X-ray images after surgery. The Xin1 system used during surgery is thereby reduced to the Xin1 marker clip (REF 100838-00) only.
- Conditions
- Proximal Humeral Fracture
- Being tested
- Xin1 Humerus System
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xin1 Humerus SystemDevice
Retrospective assessment of the surgical handling and performance of the X-ray-based tracking and navigation system "Xin1 Humerus system" evaluated from 10 proximal humerus plate fixations
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of plate fixation on the determined screw lengths derived from the Xin1 Humerus System
Xin1 Humerus System:
- Screw lengths determined after fracture reduction and temporary fixation
- Screw lengths determined after final plate fixation
Measured: during surgery
Secondary outcomes (3)
Treatment information
- Fracture classification according to AO
- Anatomical side of the fracture
- Actual screw lengths of the implanted screws
- Cumulative fluoro time
- Cumulative area dose product
- Brand and Model of used C-arm
Measured: during surgery
Patient information
- Gender
- Age
Measured: Preoperative
System information
- Accuracy estimation of the Xin1 Humerus System in terms of screw length prediction in the humeral head.
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start4 Apr 2017
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 11 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- AO Research Institute Davos
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
- Investigators
- Stefaan Nijs, Prof., Principal investigator, UZ Leuven campus Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427112
- Sponsor's protocol ID
- Xin1Humerus
- Other IDs
- 80M0661
- Status last verified
- Mar 2021
- First submitted
- 18 Jan 2018
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Voigt C, Woltmann A, Partenheimer A, Lill H. [Management of complications after angularly stable locking proximal humerus plate fixation]. Chirurg. 2007 Jan;78(1):40-6. doi: 10.1007/s00104-006-1241-0. German.
PubMed 16998660Solberg BD, Moon CN, Franco DP, Paiement GD. Locked plating of 3- and 4-part proximal humerus fractures in older patients: the effect of initial fracture pattern on outcome. J Orthop Trauma. 2009 Feb;23(2):113-9. doi: 10.1097/BOT.0b013e31819344bf.
PubMed 19169103
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Xin1 Humerus System
- ClinicalTrials.gov ID
- NCT03427112
- Acronym / sponsor ID
- Xin1Humerus
- Conditions
- Proximal Humeral Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- AO Research Institute DavosUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 9 Feb 2018 (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.
Xin1 Humerus system is an X-ray-based tracking and navigation system designed to calculate the plate position and all required proximal screw lengths for proximal humerus plate fixation. The aim is to validate the system performance in a clinical context and test the surgical handling of the Xin1 marker in a hospital environment. 10 adults having sustained a proximal humerus fracture and are indicated for plate fixation osteosynthesis will be provided intraoperatively with the Xin1 marker. The system performance is evaluated retrospectively by post-processing the intraoperative X-ray images after surgery
Detailed description
Treatment of fragility fractures at the proximal Humerus still remains a major challenge in trauma surgery. Several factors such as highly compromised bone mass, complex loading conditions, multi-fragment fractures, absent bony support and limited surgical access render the fixation particularly complex. Especially in elderly osteoporotic patients, implant position and fixation plays a key role for a successful outcome. Nowadays, complication rates of plate and screw fixation systems in the proximal Humerus region under complex fracture patterns are reported to range between 28% and 79%. A significant portion of these cases can be attributed to implant mal-placement. Particularly, when screws are too short and the subchondral bone stock is missed out, screw anchorage is significantly compromised. On the other hand, if screws are too long they might penetrate into the joint with devastating consequences. Adequate selection of screw length is hence of utmost importance. However, the particular anatomical situation challenges the determination procedure which results in prolonged operational time and increased X-ray exposure. New strategies are needed to simply, reliably and accurately fix proximal humeral fractures with plate-screw constructs. Xin1 is an X-ray-based tracking and navigation system designed to simplify a variety of surgical applications. For the Humerus application the position in space of the proximal Humerus plate is calculated in such manner, which then can be related to the position of the humeral head as derived from an image pair. All required proximal screw lengths are determined from these two radiographs. From ex-vivo evaluation the Xin1 Humerus System has proven its value in terms of accuracy increase as well as time and X-ray reduction. A clear potential for improving clinical practice is therefore apparent. The consequent next step is a first clinical phase verifying the basic function of the Xin1 system in a clinical context and investigating the surgical handling in a hospital environment.
This clinical trial aims to
- validate the Xin1 Humerus system performance in a clinical context.
- test the surgical handling of the Xin1 marker in a hospital environment.
There is no additional time effort required from the patient. All capacitated adults having sustained a proximal humerus fracture indicated for plate fixation osteosynthesis can be included in the study. The study is limited to 10 patients and 1 year. To minimize the patient risk it is suggested in this first study phase to entirely eliminate the system feedback to the surgeon during surgery. The system performance is evaluated retrospectively by post-processing X-ray images after surgery. The Xin1 system used during surgery is thereby reduced to the Xin1 marker clip (REF 100838-00) only.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with proximal humerus fracture which are transferred to the Dpt. Traumatologie, ZU Leuven, will be recruited during diagnosis and indication.
Key inclusion criteria (4 listed)
- Age 18 years and older
- Diagnosis of proximal humerus fracture
- Indicated for plate fixation osteosynthesis
- Informed consent obtained
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Xin1 Humerus SystemRetrospective assessment of the surgical handling and performance of the X-ray-based tracking and navigation system "Xin1 Humerus system" evaluated from 10 proximal humerus plate fixations | Device | – |
Primary outcome
Influence of plate fixation on the determined screw lengths derived from the Xin1 Humerus System
Time frame: during surgery
Xin1 Humerus System: * Screw lengths determined after fracture reduction and temporary fixation * Screw lengths determined after final plate fixation
3 secondary outcomes
Treatment information
Time frame: during surgery
Patient information
Time frame: Preoperative
System information
Time frame: during 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 1 Apr 2021.
- Background: PubMed 16998660Voigt C, Woltmann A, Partenheimer A, Lill H. [Management of complications after angularly stable locking proximal humerus plate fixation]. Chirurg. 2007 Jan;78(1):40-6. doi: 10.1007/s00104-006-1241-0. German.
- Background: PubMed 19169103Solberg BD, Moon CN, Franco DP, Paiement GD. Locked plating of 3- and 4-part proximal humerus fractures in older patients: the effect of initial fracture pattern on outcome. J Orthop Trauma. 2009 Feb;23(2):113-9. doi: 10.1097/BOT.0b013e31819344bf.
- 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.
Stefaan Nijs, Prof. principal investigator
UZ Leuven campus Gasthuisberg
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 Proximal Humeral Fracture, run by AO Research Institute Davos at 1 site in Belgium.
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 4 inclusion and 0 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 Apr 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 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?
Influence of plate fixation on the determined screw lengths derived from the Xin1 Humerus System (time frame: during surgery). 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 NCT03427112, 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 Apr 2021.