A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D Printed Anatomic Model, CT/MRI.
- Who it may be relevant to
- Registry conditions: Sarcoma, Ewing, Chondrosarcoma, Osteosarcoma, Fibrous Histiocytoma. Basic parameters: from 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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 up to 5 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.
Interventions
- 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
Primary outcome measures
- Operative time [Time frame: Incision to closure]
Secondary outcome measures (3)
- Blood loss [Time frame: Incision to closure]
- Adverse Events [Time frame: Surgery to 90 days post-surgery]
- Tumor margin status [Time frame: Post-surgery (+3 days)]
Eligibility criteria
Inclusion criteria
- Subjects must be at least 13 years of age.
- Subjects must have the ability to provide written informed consent.
- Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis.
- Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.
Exclusion criteria
- Pregnant or nursing women.
- Subjects that have a serious systemic pathology.
- Subjects that have clotting disorders.
- Subjects that have uncontrolled hypertension.
- Subjects that are HIV-positive.
- 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.
- Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable).
- Subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 3 centers
- Kaiser Permanente Oakland Medical Center — Oakland
- William Beaumont University Hospital — Royal Oak
- The Ohio State University Wexner Medical Center — Columbus
Identifiers
NCT: NCT06387485 · SR-001