Skip to main content
OpenTrials
Completed

NCT Number: NCT07363759

ISOVUE Comparative Trial

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lumbar Degenerative Disease Bone Diseases Degenerative Spine Intervertebral Disc Degeneration Lumbar Degenerative Disc Disease Musculoskeletal Diseases Spinal Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ISOVUE 300 Observation

Procedure

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.

ISOVUE 300 Feedback

Procedure

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.

Primary outcomes

  1. Anteroposterior Plane Clearance

    Time frame: Immediately after Discectomy

    Disc space clearance in the anteroposterior (AP) plane at the index level measured on oblique radiographs.

  2. Mediolateral Plane Clearance

    Time frame: Immediately after Discectomy/Excision Intraoperatively

    Disc space clearance in the mediolateral (ML) plane as measured by oblique radiographs.

  3. Visual Analog Scale

    Time frame: First Postoperative Clinic Appointment (within first 6 weeks)

    Visual Analog Scale survey assessing leg pain and back pain

Secondary outcomes

  1. Lumbar Lordosis

    Time frame: Immediately after Discectomy Intraoperatively

    Lumbar Lordosis as measured by oblique radiographs.

  2. Pelvic Incidence

    Time frame: Immediately after Discectomy Intraoperatively

    Pelvic incidence (PI) as measured by oblique radiographs.

  3. Disc Height

    Time frame: Immediately after Discectomy Intraoperatively

    Disc height at the index level as identified by oblique radiographs.

  4. Oswestry Disability Index

    Time frame: First Postoperative Clinic Appointment (within first 6 weeks)

    Oswestry Disability Index survey describing disability as a result of spinal conditions.

  5. Short Form Survey

    Time frame: First Postoperative Clinic Appointment (within first 6 weeks)

    SF-12 survey asking patient views about health

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Acronym: ISOVUE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.