ISOVUE Comparative Trial (ISOVUE)

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

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

Study Overview

• Status: Completed
• Conditions: Lumbar Degenerative Disc Disease; Lumbar Degenerative Disease; Degenerative Spine
• Intervention / Treatment: Procedure: ISOVUE 300 Observation; Procedure: ISOVUE 300 Feedback

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients undergoing open circumferential transforaminal lumbar interbody fusion or midline cortical TLIF for degenerative spondylolisthesis

Exclusion Criteria:

• All not in the group above

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anteroposterior Plane Clearance	Disc space clearance in the anteroposterior (AP) plane at the index level measured on oblique radiographs.	Immediately after Discectomy
Mediolateral Plane Clearance	Disc space clearance in the mediolateral (ML) plane as measured by oblique radiographs.	Immediately after Discectomy/Excision Intraoperatively
Visual Analog Scale	Visual Analog Scale survey assessing leg pain and back pain	First Postoperative Clinic Appointment (within first 6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lumbar Lordosis	Lumbar Lordosis as measured by oblique radiographs.	Immediately after Discectomy Intraoperatively
Pelvic Incidence	Pelvic incidence (PI) as measured by oblique radiographs.	Immediately after Discectomy Intraoperatively
Disc Height	Disc height at the index level as identified by oblique radiographs.	Immediately after Discectomy Intraoperatively
Oswestry Disability Index	Oswestry Disability Index survey describing disability as a result of spinal conditions.	First Postoperative Clinic Appointment (within first 6 weeks)
Short Form Survey	SF-12 survey asking patient views about health	First Postoperative Clinic Appointment (within first 6 weeks)

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Publications and helpful links

General Publications

• Lan T, Hu SY, Zhang YT, Zheng YC, Zhang R, Shen Z, Yang XJ. Comparison Between Posterior Lumbar Interbody Fusion and Transforaminal Lumbar Interbody Fusion for the Treatment of Lumbar Degenerative Diseases: A Systematic Review and Meta-Analysis. World Neurosurg. 2018 Apr;112:86-93. doi: 10.1016/j.wneu.2018.01.021. Epub 2018 Jan 31.
• de Kunder SL, van Kuijk SMJ, Rijkers K, Caelers IJMH, van Hemert WLW, de Bie RA, van Santbrink H. Transforaminal lumbar interbody fusion (TLIF) versus posterior lumbar interbody fusion (PLIF) in lumbar spondylolisthesis: a systematic review and meta-analysis. Spine J. 2017 Nov;17(11):1712-1721. doi: 10.1016/j.spinee.2017.06.018. Epub 2017 Jun 21.
• Katuch V, Grega R, Knorovsky K, Banoci J, Katuchova J, Sasala M, Ivankova H, Kapralova P. Comparison between posterior lumbar interbody fusion and transforaminal lumbar interbody fusion in the management of lumbar spondylolisthesis. Bratisl Lek Listy. 2021;122(9):653-656. doi: 10.4149/BLL_2021_105.
• Reitman CA, Anderson DG, Fischgrund J. Surgery for degenerative spondylolisthesis: open versus minimally invasive surgery. Clin Orthop Relat Res. 2013 Oct;471(10):3082-7. doi: 10.1007/s11999-013-3171-8. Epub 2013 Jul 20. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2019
• Primary Completion (Actual): June 19, 2023
• Study Completion (Actual): June 19, 2023

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: iodinated contrast; isovue
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: 18072502-IRB02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators will consider sharing if contacted with reasonable requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes