Value of 3D Modeling in Spine Surgery

Scoliosis Clinical Trial

Official title:

Value of 3D Modeling in Spine Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02771899
• Other study ID #: AAAQ6551
• Status: Recruiting
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: Columbia University
• Contact: Lawrence R Lenke, MD
• Phone: 212-305-5974
• Email: ll2989[@]columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adults (18 years and over) and children (10-17 years of age) scheduled for surgery to correct scoliosis will be included in this study, for which participation will last 6 months. Each age group of participants will be randomized to two cohorts: one cohort will receive standard of care, while the other will also have their standard radiographic images used in the construction of a three-dimensional visualization of the spine. Questionnaires administered before and after surgery, in addition to health information collected throughout the course of the study, will indicate whether the three-dimensional model has an effect on the planning, performance, and outcomes of surgery. Participants in this study will not be asked to do anything outside the standard of care. The only manipulated variable in this study is the construction of the three dimensional model, which is made from information collected during the standard of care, and requires no further action on the participant's behalf. The results of this study may show that three-dimensional visualizations can be of value to spinal surgeons, and positively affect patient outcomes.

Description:

The biplanar low-dose EOS system and its associated spineEOS workstation (EOS®, EOS Imaging, Paris, France) allows 3D spine reconstructions. The EOS system presents some advantages over MRI or CT Scans. The weight bearing position allows assessment in the functional position and the radiation exposure is 800-1000 times less then CT scans, allowing full spine acquisition even in pediatric patients. Selected anatomical landmarks are utilized to reconstruct a 3D model of the spine allowing global assessment as well as localized analysis.The aim of the study is to assess the clinical relevance of 3D stereographic reconstructions (from spineEOS 3D) on patients, adults and children, who undergo spine surgery. This study will observe the value of 3D parameters at three different steps of the standard of care surgical procedure: preoperatively, peri-operatively, and post-operatively. The goal of this prospective study is to observe how 3D reconstructions could enhance the planning, the surgery and the post-op analysis and outcomes. This pilot study could help to understand which and how 3D parameters could improve adult and pediatric spine surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 80 Years

Eligibility

Adults --

Inclusion Criteria:

• All patients must be age 18 or greater at the time of surgery or initial consultation

• Having a primary surgery of their spine (fusion or instrumentation)

Exclusion Criteria:

• Diagnosis of scoliosis other than degenerative or idiopathic (i.e., paralytic/neuromuscular, congenital)

• Undergoing revision (fusion or instrumentation)

EOS Exclusion Criteria:

• Patients with supernumerary vertebrae (one extra or one less thoracic or lumbar vertebrae)

• Insufficient quality of images to perform the 3D modeling with spineEOS software

Children --

Inclusion Criteria:

• All patients must be younger than 18 at the time of surgery

• Having a primary surgery of their spine (fusion or instrumentation)

Exclusion Criteria:

• Diagnosis of scoliosis other than degenerative or idiopathic (i.e., paralytic/neuromuscular, congenital

• Undergoing revision (fusion or instrumentation)

EOS Exclusion Criteria:

• Patients with supernumerary vertebrae (one extra or one less thoracic or lumbar vertebrae)

• Insufficient quality of images to perform the 3D modeling with spineEOS software

Related Conditions & MeSH terms

• Scoliosis

Intervention

Device:
• spineEOS software
During a full-length exam from head to feet in the standing position, 3D reconstructions of the spine, the pelvis and lower extremities using spine workflow and global postural assessment workflow on spineEOS software will be performed.
• EOS
The system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	EOS imaging Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical questionnaire score	The surgeon will complete a surgical questionnaire regarding their perceptions of the value of 3D modeling brought to the care of their patient.	1 week post-operatively
Secondary	Change in Health Related Quality Of Life (HRQOL) score	The standardized questionnaire used in the clinic.	Pre-op, 3-4 months post-op