A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning

Osteosarcoma Clinical Trial

Official title:

A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06387485
• Other study ID #: SR-001
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2024
• Source: Ricoh USA, Inc.
• Contact: Alexandra Gormley, PhD
• Phone: 484-501-0588
• Email: alexandra.gormley[@]ricoh-usa.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across 3 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging. Primary endpoint: Operative time of surgical procedure. Secondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins. Exploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Subjects must be at least 22 years of age.

2. Subjects must have the ability to provide written informed consent.

3. Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis.

4. Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.

Exclusion Criteria:

1. Pregnant or nursing women.

2. Subjects that have a serious systemic pathology.

3. Subjects that have clotting disorders.

4. Subjects that have uncontrolled hypertension.

5. Subjects that are HIV-positive.

6. Subjects that are unable to be randomized; i.e surgical team prefers to use either 3D model or standard cross-sectional imaging for surgical pre-planning.

7. Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable).

8. Subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.

Related Conditions & MeSH terms

• Chondrosarcoma
• Fibrosarcoma
• Fibrous Histiocytoma
• Histiocytoma
• Neuroectodermal Tumors, Primitive, Peripheral
• Osteosarcoma
• Sarcoma, Ewing

Intervention

Device:
• 3D Printed Anatomic Model
Patient-specific 3D printed anatomic model for pre-surgical planning

Diagnostic Test:
• CT/MRI
Standard imaging type for bony tumors

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	William Beaumont University Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ricoh USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Operative time of surgical procedure based on incision and closure time	Incision to closure
Secondary	Blood loss	Change in blood loss as determined by estimated blood loss and units of blood transfused (or blood products used) in mL.	Incision to closure
Secondary	Adverse Events	The proportion of ER visits and post operative procedure related adverse events/complications as reported at the 90-day Follow-Up Chart Review.	Surgery to 90 days post-surgery
Secondary	Tumor margin status	The proportion of negative tumor margins as determined by laboratory analysis.	Post-surgery (+3 days)