Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT07023393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Proprio Spine Measurement Tool
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Effectiveness of an Intraoperative Spine Measurement Tool and Outcomes Assessment From Its Use in Spinal Fusion Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will prospectively collect data to evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with intraoperatively achieving pre-planned alignment-related parameters to the patient's spine. The study will also collect outcomes data to determine if achievement of these spinal alignment-related parameters result in satisfactory outcomes and if it reduces the rate of secondary surgeries.
Objectives
Primary: To evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with achieving the surgeon's preplanned alignment-related parameters intraoperatively.
Secondary: To determine if there is a correlation between 1) achievement of preoperative planned alignment-related parameters intraoperatively, and 2) outcomes.
Hypothesis
The application of the intraoperative spinal measurement tool for patients undergoing spinal fusion surgery will improve the surgeon's ability to achieve pre-planned alignment-related parameters intraoperatively and doing so will provide improved outcomes.
Objectives
Primary: To evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with achieving the surgeon's preplanned alignment-related parameters intraoperatively.
Secondary: To determine if there is a correlation between 1) achievement of preoperative planned alignment-related parameters intraoperatively, and 2) outcomes.
Hypothesis
The application of the intraoperative spinal measurement tool for patients undergoing spinal fusion surgery will improve the surgeon's ability to achieve pre-planned alignment-related parameters intraoperatively and doing so will provide improved outcomes.
Detailed Description:
Patient reported outcomes data will be collected on two separate forms- the Oswestry Disability Index (ODI) and the SF-36. The ODI has been widely used since its development in 1980 and has been viewed as effective for measuring disability in daily living associated with low back pain4. The SF-36 is the most used patient reported outcomes measure used both generically as well as specifically for low back pain, and it consists of both a mental as well as physical assessment5. Study data will be compared to historical literature data.
The intraoperative spinal measurement system to be used is the Paradigm TM System by Proprio.
Patients will fill out ODI and SF-36 and will have a postoperative standing long x-ray or EOS at regular follow-up intervals (typically 6w, 3m, 6m, 12m, 24m).
The intraoperative spinal measurement system to be used is the Paradigm TM System by Proprio.
Patients will fill out ODI and SF-36 and will have a postoperative standing long x-ray or EOS at regular follow-up intervals (typically 6w, 3m, 6m, 12m, 24m).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: