ISOVUE Comparative Trial

NCT07363759 | Completed

• 1 other identifier: 18072502-IRB02
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lumbar Degenerative Disc Disease; Degenerative Spine; Lumbar Degenerative Disease

Keywords

isovue; iodinated contrast

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Lumbar Lordosis

  Immediately after Discectomy Intraoperatively

• Pelvic Incidence

  Immediately after Discectomy Intraoperatively

• Disc Height

  Immediately after Discectomy Intraoperatively

• Oswestry Disability Index

  First Postoperative Clinic Appointment (within first 6 weeks)

• Short Form Survey

  First Postoperative Clinic Appointment (within first 6 weeks)

Study Arms (2)

Observation

PLACEBO COMPARATOR

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

Feedback

EXPERIMENTAL

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

Interventions

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.

Observation

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.

Feedback

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• All not in the group above

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

• 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.

  PMID: 28647584 BACKGROUND

• 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.

  PMID: 29367001 BACKGROUND

• 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.

  PMID: 34463112 BACKGROUND

• 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.

  PMID: 23873608 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After obtaining informed consent, patients were randomized into either a control (Observation) or investigational (Feedback) group. In the observation group, after initial discectomy, ISOVUE M300 contrast was administered into the disc space via angiocatheter to assess the extent of discectomy by obtaining orthogonal radiographs of the contrast-enhanced space. Then, the contrast agent was extracted via suction and the disc space was irrigated with saline. The case then proceeded with graft/cage insertion without additional excision. In the feedback group, prior to graft/cage insertion, the surgeon used the contrast feedback to enhance the preparation.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 23, 2026
• Study Start: April 11, 2019
• Primary Completion: June 19, 2023
• Study Completion: June 19, 2023
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)