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NOT YET RECRUITING
NCT07023393
NA

Proprio Spine Measurement Tool

Sponsor: Duke University

View on ClinicalTrials.gov

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.

Official title: Effectiveness of an Intraoperative Spine Measurement Tool and Outcomes Assessment From Its Use in Spinal Fusion Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-02-05

Completion Date

2029-02-05

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

DEVICE

Intraoperative spinal measurement system

The design is a prospective study to evaluate the effectiveness of a novel intraoperative spinal measurement tool to assist the surgeon with achieving preoperatively planned alignment-related parameters during surgery.

Locations (1)

Duke University Health System

Durham, North Carolina, United States