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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Sarcoma, Ewing Chondrosarcoma Osteosarcoma Fibrous Histiocytoma Fibrosarcoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Imaging

Participants in this arm will undergo tumor excision with prior planning utilizing only Imaging (CT or MRI) without development of a 3D printed model

Group Type ACTIVE_COMPARATOR

CT/MRI

Intervention Type DIAGNOSTIC_TEST

Standard imaging type for bony tumors

3D Printed Anatomic Model

Participants in this arm will have tumors excised with prior planning utilizing 3D printed models and Imaging (CT or MRI).

Group Type EXPERIMENTAL

3D Printed Anatomic Model

Intervention Type DEVICE

Patient-specific 3D printed anatomic model for pre-surgical planning

CT/MRI

Intervention Type DIAGNOSTIC_TEST

Standard imaging type for bony tumors

Interventions

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3D Printed Anatomic Model

Patient-specific 3D printed anatomic model for pre-surgical planning

Intervention Type DEVICE

CT/MRI

Standard imaging type for bony tumors

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No