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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether 3D technology can improve the planning process for nasal reconstruction surgery. Researchers aim to determine if 3D scanning and printing before surgery are safer and more effective than traditional planning methods. Participants will receive either the standard planning or the new 3D Nasal Reconstruction Planning. The trial seeks adults scheduled for nasal reconstruction surgery who are patients at a specific facial plastic surgery clinic. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance surgical outcomes.

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 prior data suggests that 3D Nasal Reconstruction Planning is safe?

Research has shown that using 3D technology in nose reconstruction is generally safe for patients. Studies have found that 3D printing and imaging help doctors plan surgeries more effectively and explain them more clearly to patients. This technology enables doctors to create accurate models and guides, enhancing surgical precision and improving outcomes.

Although specific data on issues with 3D planning for nose reconstruction is lacking, the technology is well-accepted in similar medical contexts. This suggests it is a safe option for those considering participation in a clinical trial involving 3D planning for nose surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 3D Nasal Reconstruction Planning because it offers a cutting-edge approach to planning nasal surgeries. Unlike traditional methods that rely on 2D imaging and the surgeon's experience, this technique uses advanced 3D modeling to create a precise, virtual representation of the patient's nasal structure. This allows for more accurate surgical planning, potentially leading to better outcomes and reduced risk of complications. By providing a clearer visualization of the procedure beforehand, surgeons can tailor their approach to each patient's unique anatomy, which could enhance both aesthetic and functional results.

What evidence suggests that 3D Nasal Reconstruction Planning is effective for nasal surgery?

Research has shown that 3D Nasal Reconstruction Planning, tested in this trial, can significantly enhance surgical precision and patient recovery. Participants may receive 3D planning, which involves creating detailed models and guides to help surgeons plan surgeries more accurately. This technology also aids doctors in explaining procedures to patients, ensuring they understand what to expect. Studies indicate that 3D tools in nasal surgery can lead to better outcomes and higher patient satisfaction. Overall, 3D planning technology offers a promising improvement in the accuracy and success of nasal surgeries. ^{3 4 5 6 7}

Who Is on the Research Team?

Brittany Howard, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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 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 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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12190116/

3D Printing in Nasal Reconstruction - PubMed Central - NIH

3D printing facilitates the creation of anatomical models, surgical guides, and implants, enhancing surgical precision and patient outcomes.

2.

withpower.com

withpower.com/trial/phase-nasal-surgical-procedures-3-2022-0d623

3D 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, ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11457523/

Advancing Precision Rhinoplasty: Preoperative Digital 3D ...

The aim of the study is to assess the efficacy and advantages of utilizing state-of-the-art three-dimensional (3D) reconstruction technology ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2096691121001023

Application of digital technology in nasal reconstruction

Digital technology can be used in nasal reconstruction for preoperative simulation, intraoperative guide, and postoperative follow-up.

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ejo.springeropen.com

ejo.springeropen.com/articles/10.1186/s43163-025-00850-2

3D bioprinting in nasal surgery: a comprehensive review

Incorporating 3D printing into nasal reconstructive procedures increases surgical accuracy, maximizes patient results, and enhances overall ...

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thieme-connect.com

thieme-connect.com/products/ejournals/abstract/10.1055/s-0041-1741501

Three-Dimensional Technology in Rhinoplasty

3D surface imaging of preoperative and postoperative nasal structure provides a platform for better surgical planning and patient counselling.

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researchgate.net

researchgate.net/publication/392589866_3D_Printing_in_Nasal_Reconstruction_Application-Based_Evidence_on_What_Works_When_and_Why

3D Printing in Nasal Reconstruction: Application-Based ...

This review explores the applications, benefits, and challenges of integrating 3D printing in nasal reconstruction. Methods: A literature search ...