NCT07023393

Proprio Spine Measurement Tool

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Spinal Curvatures
• Spinal Osteochondrosis
• Spinal Osteophytosis
• Spinal Stenosis
• Spondylitis
• Spondylosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-05
• Primary completion: 2027-02-05
• Completion: 2029-02-05
• First posted: 2025-06-17
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study