Fractures, BoneNCT03764501
Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy
A study testing Image fusion system in people with Fractures, Bone and Fracture Malunion, Bone, run by Tokyo Medical University at 1 site in Japan.
Trial summary
Utility of image fusion system for the fracture and fracture malunion management will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures, Bone, Fracture Malunion, Bone
- What is being tested?
- Image fusion system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- 21 May 2018to 31 Dec 2024
- 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
- Fracture paitents need osteosynthesis
Who cannot join
- Fracture patients under 18 years old
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Tokyo Medical University Ibaraki Medical Center
Ami, Ibaraki, 300-0395
Yuichi Yoshii, 81298871161
About this study
Utility of image fusion system for the fracture and fracture malunion management will be evaluated.
Read the detailed description
The fracture and malunion patients need osteosynthesis or osteotomy will be recruited. Image fusion group utilizes 3D preoperative planning and image fusion system. Control group utilizes only 3D preoperative planning. The age, sex, and fracture types will be matched between groups. In both groups, 3D preoperative planning will be performed in order to determine reduction, placement and choices of implants. In the image fusion group, the outline of planned image will be displayed on the monitor overlapping with fluoroscopy image during surgery. Reductions, implant choices/positions, and clinical outcomes will be evaluated.
- Conditions
- Fractures, Bone, Fracture Malunion, Bone
- Being tested
- Image fusion system
- Medical subject headings
- Fractures, Bone, Fractures, Malunited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image fusion systemDevice
Image fusion system for the 3D preoperative planning
| Study group | Role | What they receive |
|---|---|---|
| Image fusion group (Image fusion) | Active comparator | Use image fusion system during surgery (Image fusion, ZedTrauma, LEXI Co., Ltd.) Receives: Device: Image fusion system |
| Control group (ZedTrauma) | No intervention | only use 3D preoperative planning (Zed Trauma, LEXI Co., Ltd.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction accuracy
Reproducibility of the reduction shape will be measured.
Measured: 1month after the surgery
Implant placement
Reproducibility of the implant placement will be evaluated.
Measured: 1month after the surgery
Implant choices
Reproducibility of the implant choices will be evaluated.
Measured: 1month after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start21 May 2018
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Fractures, BoneStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Image fusion group will utilize 3D preoperative planning and image fusion system. Control group will utilize only 3D preoperative planning.
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT03764501
- Sponsor's protocol ID
- 18-19
- Status last verified
- Apr 2022
- First submitted
- 3 Dec 2018
- Last updated
- 27 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoshii Y, Ogawa T, Hara Y, Totoki Y, Ishii T. An image fusion system for corrective osteotomy of distal radius malunion. Biomed Eng Online. 2021 Jun 30;20(1):66. doi: 10.1186/s12938-021-00901-8.
PubMed 34193171Yoshii Y, Totoki Y, Sashida S, Sakai S, Ishii T. Utility of an image fusion system for 3D preoperative planning and fluoroscopy in the osteosynthesis of distal radius fractures. J Orthop Surg Res. 2019 Nov 6;14(1):342. doi: 10.1186/s13018-019-1370-z.
PubMed 31694677
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
- Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy
- ClinicalTrials.gov ID
- NCT03764501
- Acronym / sponsor ID
- 18-19
- Conditions
- Fractures, Bone, Fracture Malunion, Bone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tokyo Medical UniversityUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Dec 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.
Utility of image fusion system for the fracture and fracture malunion management will be evaluated.
Detailed description
The fracture and malunion patients need osteosynthesis or osteotomy will be recruited. Image fusion group utilizes 3D preoperative planning and image fusion system. Control group utilizes only 3D preoperative planning. The age, sex, and fracture types will be matched between groups. In both groups, 3D preoperative planning will be performed in order to determine reduction, placement and choices of implants. In the image fusion group, the outline of planned image will be displayed on the monitor overlapping with fluoroscopy image during surgery. Reductions, implant choices/positions, and clinical outcomes will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Image fusion group will utilize 3D preoperative planning and image fusion system. Control group will utilize only 3D preoperative planning.
| Arm | Type | Receives |
|---|---|---|
| Image fusion group (Image fusion) | Active comparator | Device: Image fusion systemUse image fusion system during surgery (Image fusion, ZedTrauma, LEXI Co., Ltd.) |
| Control group (ZedTrauma) | No intervention | –only use 3D preoperative planning (Zed Trauma, LEXI Co., Ltd.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fracture paitents need osteosynthesis
Key exclusion criteria (1 listed)
- Fracture patients under 18 years old
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 |
|---|---|---|
| Image fusion systemImage fusion system for the 3D preoperative planning | Device | Image fusion group (Image fusion) |
Primary outcome
Reduction accuracy
Time frame: 1month after the surgery
Reproducibility of the reduction shape will be measured.
Implant placement
Time frame: 1month after the surgery
Reproducibility of the implant placement will be evaluated.
Implant choices
Time frame: 1month after the surgery
Reproducibility of the implant choices will be evaluated.
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 34193171Yoshii Y, Ogawa T, Hara Y, Totoki Y, Ishii T. An image fusion system for corrective osteotomy of distal radius malunion. Biomed Eng Online. 2021 Jun 30;20(1):66. doi: 10.1186/s12938-021-00901-8.
- Derived from this study: PubMed 31694677Yoshii Y, Totoki Y, Sashida S, Sakai S, Ishii T. Utility of an image fusion system for 3D preoperative planning and fluoroscopy in the osteosynthesis of distal radius fractures. J Orthop Surg Res. 2019 Nov 6;14(1):342. doi: 10.1186/s13018-019-1370-z.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image fusion system in people with Fractures, Bone and Fracture Malunion, Bone, 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 M Yoshii (81298871161 ext. 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 accuracy (time frame: 1month after the surgery). The study lists 3 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 NCT03764501, 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 27 Apr 2022.