3D Reconstruction Planning for Nasal Surgery

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Age < 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to gather information on the safety and effectiveness and compare nasal reconstruction standard planning versus 3D preoperative scanning/printing/planning.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment 3D Nasal Reconstruction Planning for nasal surgery?

Research shows that using 3D imaging and printing in nasal surgeries helps surgeons plan better and communicate more clearly with patients, leading to improved surgical outcomes. These techniques allow for precise preoperative planning and accurate assessment of changes in the nose's shape and volume after surgery. ^{1 2 3 4 5}

Is 3D reconstruction planning for nasal surgery safe for humans?

The research shows that 3D reconstruction planning for nasal surgery has been used safely in humans, with benefits like better understanding of anatomy and improved surgical accuracy, though it may be time-consuming and costly. ^{3 5 6 7 8}

How is 3D Nasal Reconstruction Planning different from other nasal reconstruction treatments?

3D Nasal Reconstruction Planning is unique because it uses advanced 3D imaging and printing technology to create personalized surgical guides and models, enhancing precision and symmetry in nasal surgeries. This approach allows for detailed preoperative planning and the creation of custom tools that can be used during surgery, which is not typically possible with traditional methods. ^{3 9 10 11 12}

Research Team

Brittany Howard, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for men and women aged 18 to 100 who are planning to undergo nasal reconstruction. They must be patients from the Facial Plastic Surgery clinic of the Principal Investigator. Children under 18 are excluded due to shared postoperative follow-up with pediatric providers.

Inclusion Criteria

I am between 18 and 100 years old.

Patients will be identified from the Facial Plastic Surgery clinic of the PI

I am scheduled for nasal reconstruction surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo nasal reconstruction using either standard planning or 3D preoperative scanning/printing/planning techniques

6 months

Follow-up

Participants are monitored for safety and effectiveness after nasal reconstruction

6 months

Treatment Details

Interventions

• 3D Nasal Reconstruction Planning

Trial Overview The study aims to compare traditional nasal reconstruction planning methods with a new approach using preoperative scanning, printing, and planning in three dimensions (3D) for safety and effectiveness.

Participant Groups

Group I: 3D Nasal Reconstruction Planning Experimental Treatment 1 Intervention

Subjects undergoing nasal reconstruction will have 3D planning utilized by the surgical team for the procedure.

Group II: Standard of Care Nasal Reconstruction Planning Active Control 1 Intervention

Subjects undergoing nasal reconstruction will have standard planning for procedure.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

The study highlights the transition from traditional two-dimensional evaluations to advanced three-dimensional (3D) analysis techniques for assessing nasal shape after rhinosurgery, improving outcome analysis.

3D laser surface scanners are proposed as a feasible tool for both preoperative planning and quality control in rhinosurgery, potentially enhancing surgical precision and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional laser surface scanning in rhinosurgery. Largo, RD., Wettstein, R., Fulco, I., et al.[2019]

A new, cost-effective method for creating patient-specific 3D-printed models for rhinoplasty has been developed, allowing for better preoperative planning and communication with patients, with a total materials cost of about $5.00 per model.

This technique has been successfully used for 12 patients, demonstrating that 3D printing can be efficiently integrated into rhinoplasty procedures, with model preparation taking around 3 hours and printing requiring 18 to 24 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-House Manufacture of Sterilizable, Scaled, Patient-Specific 3D-Printed Models for Rhinoplasty. Bekisz, JM., Liss, HA., Maliha, SG., et al.[2020]

A new virtual planning protocol using 3D image registration technology was developed to restore total nasal defects, showing promising clinical efficacy in achieving accurate surgical outcomes.

Postoperative evaluations indicated that the nasal shapes were well restored, with mean errors in the 3D models ranging from 0.92 to 1.04 mm, demonstrating the precision of this method in facial reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Combined Application of Database and Three-Dimensional Image Registration Technology in the Restoration of Total Nose Defect. Zeng, W., Chen, G., Ju, R., et al.[2018]

Three-dimensional (3D) imaging techniques have transformed preoperative assessments in rhinoplasty by allowing surgeons to better communicate with patients about their desired outcomes and to create more precise surgical plans.

3D surface imaging not only enhances the understanding of aesthetic goals but also enables accurate measurement of changes in the nose's shape and volume after surgery, improving postoperative evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-Dimensional Surface Imaging and the Continuous Evolution of Preoperative and Postoperative Assessment in Rhinoplasty. Lekakis, G., Claes, P., Hamilton, GS., et al.[2022]

The use of a 3D radiologic viewer for preoperative planning in rhinoplasty significantly increased patient decisions to undergo surgery and improved overall satisfaction, as evaluated 12 months post-operation.

Patients who used the 3D viewer experienced fewer requests for reinterventions and reported better nasal function improvements, highlighting the efficacy of this technology in enhancing surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative digital three-dimensional planning for rhinoplasty. Moscatiello, F., Herrero Jover, J., González Ballester, MA., et al.[2010]

The study demonstrates the successful use of a 3D-printed intraoperative surgical guide in reconstructing complex nasal defects in three patients, showcasing the potential of advanced technology in surgical procedures.

This approach emphasizes a collaborative effort between surgeons and anaplastologists, indicating that multidisciplinary teamwork can enhance patient outcomes in complex reconstructive surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Custom-made, 3D, intraoperative surgical guides for nasal reconstruction. Sultan, B., Byrne, PJ.[2022]

The study involved 481 surgical interventions in the maxillofacial region and related areas, utilizing three-dimensional imaging and simulation techniques to enhance surgical preparation and accuracy.

Using these advanced simulation methods improved understanding of anatomical relationships and localization during surgery, leading to better outcomes in reconstructive procedures, despite the higher time and cost involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image- and model-based surgical planning in otolaryngology. Korves, B., Klimek, L., Klein, HM., et al.[2022]

Using 3D printing to create real-size models of facial bones significantly aids in the preoperative planning for rhinoplasty, especially for correcting traumatic nasal deformities.

In a study involving 11 cases, the surgical plan based on the 3D-printed models was successfully executed in 10 cases (90.9%), demonstrating the efficacy of this technique in improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Specific 3-Dimensional Printed Models for Planning Nasal Osteotomy to Correct Nasal Deformities Due to Trauma. Jung, YG., Park, H., Seo, J.[2020]

A novel approach for subtotal nasal reconstruction using a fasciocutaneous free flap was successfully implemented, supported by computer-aided design (CAD) and computer-aided manufacturing (CAM) techniques.

The use of a 3D printed guide to recreate the nasal cartilage framework allowed for a more precise and effective reconstruction, demonstrating the potential of advanced technology in complex surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) 3D Printing Method for Nasal Framework Reconstruction Using Microvascular Free Flaps. Chiesa-Estomba, CM., González-García, J., Sistiaga-Suarez, JA., et al.[2022]

In a study involving 20 patients undergoing nasal reconstruction, the use of three-dimensional printing technology (CAD/CAM) resulted in significantly more symmetric nasal reconstructions compared to traditional methods, particularly in alar width and area.

The CAD/CAM group showed fewer asymmetries overall, with only nostril-related parameters remaining asymmetric, highlighting the efficacy of 3D printing in improving surgical outcomes in complex nasal reconstructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-aided design and three-dimensional printing improves symmetry in heminasal reconstruction outcomes. Yen, CI., Zelken, JA., Chang, CS., et al.[2020]

Recent advancements in 3D imaging and printing technology significantly improve the assessment and planning of rhinoplasty, allowing for the creation of personalized surgical tools such as cutting and marking guides.

3D printing enhances the entire rhinoplasty process by providing reference models and nasal splints, which improve communication with patients and potentially lead to better surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Surgical Planning and Three-Dimensional Printing in Rhinoplasty. Townsend, A., Tepper, OM.[2023]

The study introduces digital preoperative planning for nasal reconstruction using 3D modeling, which allows for more precise and tailored flap designs compared to traditional manual templating methods.

By applying digital templates to three representative cases, the study demonstrates improved workflow and accuracy in creating 2D skin flap shapes from complex 3D nasal geometries, enhancing the overall effectiveness of the forehead flap procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Forehead Flap Templates for Nasal Reconstruction Digitally Developed From 2D and 3D Images. Fishman, Z., Whyne, CM., Fialkov, JA.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Three-dimensional laser surface scanning in rhinosurgery. [2019]

2. England pubmed.ncbi.nlm.nih.gov

In-House Manufacture of Sterilizable, Scaled, Patient-Specific 3D-Printed Models for Rhinoplasty. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

The Combined Application of Database and Three-Dimensional Image Registration Technology in the Restoration of Total Nose Defect. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Three-Dimensional Surface Imaging and the Continuous Evolution of Preoperative and Postoperative Assessment in Rhinoplasty. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Preoperative digital three-dimensional planning for rhinoplasty. [2010]

6. United States pubmed.ncbi.nlm.nih.gov

Custom-made, 3D, intraoperative surgical guides for nasal reconstruction. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Image- and model-based surgical planning in otolaryngology. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Patient-Specific 3-Dimensional Printed Models for Planning Nasal Osteotomy to Correct Nasal Deformities Due to Trauma. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

A Novel Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) 3D Printing Method for Nasal Framework Reconstruction Using Microvascular Free Flaps. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Computer-aided design and three-dimensional printing improves symmetry in heminasal reconstruction outcomes. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Virtual Surgical Planning and Three-Dimensional Printing in Rhinoplasty. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Forehead Flap Templates for Nasal Reconstruction Digitally Developed From 2D and 3D Images. [2022]