Distal Humerus FractureNCT04349319
Development of Three Dimensional Preoperative Planning System for the Osteosynthesis of Distal Humerus Fractures
A study testing Digital preoperative planning in people with Distal Humerus Fracture, run by Tokyo Medical University at 1 site in Japan.
Trial summary
To reproduce anatomical reduction and appropriate implant placement/choices during osteosynthesis for elbow fractures, a 3D preoperative planning system was developed. To assess the utility of 3D digital preoperative planning for the osteosynthesis of distal humerus fractures, the reproducibility of implant reduction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Humerus Fracture
- What is being tested?
- Digital preoperative planning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- 1 Oct 2017to Mar 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Distal humerus fracture patients
Who cannot join
- Patients with a previous history of traumatic injuries to the elbow
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Tokyo Medical University Ibaraki Medical Center
Ami, Ibaraki, 305-0395
Yuichi Yoshii, 81298871161, yy12721@yahoo.co.jp
About this study
To reproduce anatomical reduction and appropriate implant placement/choices during osteosynthesis for elbow fractures, a 3D preoperative planning system was developed. To assess the utility of 3D digital preoperative planning for the osteosynthesis of distal humerus fractures, the reproducibility of implant reduction shapes and placements in patients with distal humerus fractures will be evaluated.
Read the detailed description
3D preoperative planning will be applied for four distal humerus fracture cases . The preoperative planning will be performed in order to determine the reduction, placement and choices of implants. After the operation, the accuracy of the reduction and implants choices and placements will be verified. The reductions will be evaluated with an angle between the diaphysis axis and a line connecting the medial epicondyle with the lateral epicondyle and an angle between the diaphysis axis and the articular surface in the coronal plane and distance between the anterior diaphysis and the anterior articular surface in the sagittal plane for the 3D images of distal humerus. The reproducibility will be evaluated by the differences of the parameters between pre- and post-operative images.
- Conditions
- Distal Humerus Fracture
- Being tested
- Digital preoperative planning
- Medical subject headings
- Humeral Fractures, Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital preoperative planningDevice
Before the osteosynthesis of distal humerus fracture, we perform digital preoperative planning.
| Study group | Role | What they receive |
|---|---|---|
| Digital preoperative planning | Other | To use digital preoperative planning software Receives: Device: Digital preoperative planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction shape
Reduction shape parameter
Measured: 1 year
Implant placement
Implant placement parametes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Oct 2017
- Primary completionMar 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Humerus 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A case control study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokyo Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuichi Yoshii, Tokyo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349319
- Sponsor's protocol ID
- 14-21(distal humerus)
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yoshii Y, Iwabuchi S, Ikumi A, Kohyama S, Ogawa T, Ishii T. Correlations between 3D preoperative planning and postoperative reduction in the osteosynthesis of distal humeral fractures. J Orthop Surg Res. 2023 Apr 8;18(1):283. doi: 10.1186/s13018-023-03772-y.
PubMed 37031170
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Three Dimensional Preoperative Planning System for the Osteosynthesis of Distal Humerus Fractures
- ClinicalTrials.gov ID
- NCT04349319
- Acronym / sponsor ID
- 14-21(distal humerus)
- Conditions
- Distal Humerus Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tokyo Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 16 Apr 2020 (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.
To reproduce anatomical reduction and appropriate implant placement/choices during osteosynthesis for elbow fractures, a 3D preoperative planning system was developed. To assess the utility of 3D digital preoperative planning for the osteosynthesis of distal humerus fractures, the reproducibility of implant reduction shapes and placements in patients with distal humerus fractures will be evaluated.
Detailed description
3D preoperative planning will be applied for four distal humerus fracture cases . The preoperative planning will be performed in order to determine the reduction, placement and choices of implants. After the operation, the accuracy of the reduction and implants choices and placements will be verified. The reductions will be evaluated with an angle between the diaphysis axis and a line connecting the medial epicondyle with the lateral epicondyle and an angle between the diaphysis axis and the articular surface in the coronal plane and distance between the anterior diaphysis and the anterior articular surface in the sagittal plane for the 3D images of distal humerus. The reproducibility will be evaluated by the differences of the parameters between pre- and post-operative images.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A case control study
| Arm | Type | Receives |
|---|---|---|
| Digital preoperative planning | Other | Device: Digital preoperative planningTo use digital preoperative planning software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Distal humerus fracture patients
Key exclusion criteria (1 listed)
- Patients with a previous history of traumatic injuries to the elbow
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 |
|---|---|---|
| Digital preoperative planningBefore the osteosynthesis of distal humerus fracture, we perform digital preoperative planning. | Device | Digital preoperative planning |
Primary outcome
Reduction shape
Time frame: 1 year
Reduction shape parameter
Implant placement
Time frame: 1 year
Implant placement parametes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 37031170Yoshii Y, Iwabuchi S, Ikumi A, Kohyama S, Ogawa T, Ishii T. Correlations between 3D preoperative planning and postoperative reduction in the osteosynthesis of distal humeral fractures. J Orthop Surg Res. 2023 Apr 8;18(1):283. doi: 10.1186/s13018-023-03772-y.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital preoperative planning in people with Distal Humerus Fracture, run by Tokyo Medical University at 1 site in Japan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Apr 2022. 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 Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuichi Yoshii (81298871161, yy12721@yahoo.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction shape (time frame: 1 year). 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 NCT04349319, which also lists 1 linked publication.
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 27 Apr 2022.