3D printing and planning for orbital floor (bottom part of the eye socket) fractures
| ISRCTN | ISRCTN12793225 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12793225 |
| Secondary identifying numbers | 2-PEK-4/132/2022 |
- Submission date
- 12/03/2023
- Registration date
- 14/03/2023
- Last edited
- 14/03/2023
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
An orbital floor fracture is a type of facial fracture that affects the floor or bottom part of the eye socket (orbit). The orbit is made up of several bones, including the maxilla, zygomatic, and frontal bones, which protect the eye and its surrounding structures.
Fixing a broken orbital floor can be hard because of how complicated its structure is and how difficult it is to get to. The best way to treat it in grown-ups is by using a titanium mesh to fix it through open surgery. With new 3D printing technology, doctors can plan the surgery better before they start, which is especially useful if they can't use a CT scan or navigation during the surgery. This study aims to see if using 3D printing and planning made treating orbital floor fractures more successful than not using it.
Who can participate?
Adult patients with isolated orbital floor fractures, who are administrated in P. Stradins Clinical University hospital in Latvia.
What does the study involve?
In this study, 3D-printed models of the eye socket will be used to help with surgery. The doctors will use the model to guide them as they bend a piece of titanium mesh to fit in the patient's eye socket. They will then perform surgery to repair the broken bone in the eye socket using the pre-bent titanium mesh. They will take a CT scan before and after the surgery to check the results. They will also ask the patient to evaluate their vision after the surgery, after 1 week, after 2 months, and after 6 months. A measurement tool will be used to analyze the size of the eye socket before and after the surgery.
What are the possible benefits and risks of participating?
Possible benefits of participating - more precise surgery, faster recovery, and undisturbed quality of life. Risks - as any other surgery.
Where is the study run from?
Riga Stradins University, Institute of Stomatology (Baltic biomaterials centre of excellence) and P. Stradins Clinical University Hospital (Latvia)
When is the study starting and how long is it expected to run for?
January 2022 to December 2026
Who is funding the study?
Riga Stradins University and RSU Institute of Stomatology (Latvia)
Who is the main contact?
Ieva Bagante (MD, DDS, PhD), Ieva.Bagante@rsu.lv
Contact information
Principal Investigator
Peldu 8
Ikskile
LV-5052
Latvia
 ORCID ID |
0000-0003-0982-4877 |
|---|---|
| Phone | +371 29707778 |
| Ieva.Bagante@rsu.lv |
Study information
| Study design | Single centre cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 43346 PIS (in Latvian).pdf |
| Scientific title | 3D printing and planning for surgery of orbital floor fractures in adult patients to improve patient related outcome. A comparison with retrospective patients group with orbital floor fracture reconstruction without 3D printing and planning |
| Study acronym | 3D OFF |
| Study objectives | 3D printing and planning of orbital floor fractures gives higher success rate and faster recovery. |
| Ethics approval(s) | Approved 09/03/2022, Research Ethics Committee of Riga Stradins University (Riga Stradins University Main building Dzirciema 16 street, Riga, Latvia, LV-1007; +371 26691306; pek@rsu.lv), ref: Nr. 2-PĒK-4/132/2022 |
| Health condition(s) or problem(s) studied | 3D printing and planning for orbital floor fractures |
| Intervention | All consecutive adult patients with isolated orbital floor fracture were included in the study. CT scan before and after surgery. 3D printing and planning before surgery + pre bended implant (printed patient specific implant). Orbital floor reconstruction with pre-bended titanium mesh (standard procedure). Orbital volume measurement before and after surgery. Clinical diplopia evaluation after 1 week, after 2 months, after 6 months (if persistent) To compare data with control group (patients’ CT scan after surgery without 3D planning), orbital volume and success rate (repeated intervention, persistent diplopia). To compare late clinical outcome with questionnaire at least 6 months after surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Orbital volume changes were measured before and after repairment and compared with intact orbit. Measurements was preformed using 3D slicer image Computing Platform for the Quantitative Image Network |
| Secondary outcome measures | Clinical diplopia evaluation after 1 week, after 2 months, and after 6 months (if persistent) using a questionnaire with a visual analogue scale |
| Overall study start date | 01/01/2022 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. All consecutive adult patients with isolated orbital floor fracture, who were treated in P. Stradins Clinical University hospital from 01/01/2022 2. Residents of Latvia |
| Key exclusion criteria | 1. Non residents of Latvia, e.g. refugees 2. Additional facial fractures e.g. zygomatic bone fractures 3. Poor quality CT scan 4. Missing CT scan 5. Not attended control visits 6. Mentally disabled patients 7. Children |
| Date of first enrolment | 09/03/2022 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- Latvia
Study participating centres
Riga
LV-1007
Latvia
Riga
LV-1007
Latvia
Sponsor information
University/education
Dzirciema 16
Riga
LV-1007
Latvia
| Phone | +371 67062711 |
|---|---|
| zd@rsu.lv | |
| Website | http://www.rsu.lv/eng/ |
"ROR" |
https://ror.org/03nadks56 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Rīga Stradiņš University, Rīga Stradiņš University, Universitas Rigensis Stradina, Riga Medical Institute, Medical Academy of Latvia, RSU
- Location
- Latvia
Results and Publications
| Intention to publish date | 31/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request Ieva Bagante, Ieva.Bagante@rsu.lv |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in Latvian | 14/03/2023 | No | Yes | |
| Protocol file | 14/03/2023 | No | No |
Additional files
- 43346 PIS (in Latvian).pdf
- in Latvian
- 43346 Protocol.pdf
Editorial Notes
14/03/2023: Trial's existence confirmed by Research Ethics Committee of Riga Stradins University.
