NCT07363759

ISOVUE Comparative Trial

ISOVUE Contrast for Intraoperative Assessment of Discectomy Quality in TLIF: A Prospective Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

This study aimed to investigate a novel technique for intraoperative quantitative and qualitative feedback during discectomy and endplate preparation in TLIF.

Detailed description

The purpose of this study was to introduce a novel surgical technique using ISOVUE-300M contrast dye for intraoperative visualization of discectomy progress and to test the value of this technique by comparing outcomes of two patient cohorts. The investigators hypothesize that the standard TLIF technique results in a surprisingly low percentage of effective disc preparation, even when performed by an experienced TLIF surgeon. Secondly, the investigators hypothesize that by using intraoperative visual feedback to guide a second discectomy pass that the extent of disc space preparation can be substantially improved compared to patients where visual feedback is not available. Lastly, the investigators aim to conduct a clinical outcomes analysis evaluating radiographic and complication outcomes. To the best of the authors' knowledge, this prospective study is the first to evaluate differences in disc space preparation using a novel contrast-based technique while also providing clinical outcomes.

Conditions

• Lumbar Degenerative Disease
• Lumbar Degenerative Disc Disease
• Degenerative Spine

Interventions

Type	Name	Description
PROCEDURE	ISOVUE 300 Observation	In the Observation group, after initial discectomy and endplate preparation,ISOVUE-300M contrast was administered into the disc space and orthogonal anterior-posterior and lateral radiographs were obtained. The case then proceeded with graft and cage insertion without additional disc excision or endplate work.
PROCEDURE	ISOVUE 300 Feedback	In the Feedback group, the surgeon was permitted to utilize the ISOVUE imaging as a feedback mechanism to then re-prepare the disc space prior to final graft/cage insertion. An additional dose of ISOVUE-300M was administered into the disc space with repeat radiographs obtained prior to grafting/cage insertion to demonstrate the effect of the second pass of disc and cartilage removal.

Timeline

• Start date: 2019-04-11
• Primary completion: 2023-06-19
• Completion: 2023-06-19
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States