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

Description

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.

Conditions

Sarcoma, Ewing, Chondrosarcoma, Osteosarcoma, Fibrous Histiocytoma, Fibrosarcoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Sarcoma, Ewing
Intervention / Treatment

-

Contacts and Locations

Royal Oak

William Beaumont University Hospital, Royal Oak, Michigan, United States, 48073

Columbus

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ricoh USA, Inc.,

Study Record Dates

2025-04-01