Lumbar Degenerative DiseaseISOVUENCT07363759
ISOVUE Comparative Trial
A study testing ISOVUE 300 Observation and ISOVUE 300 Feedback in people with Lumbar Degenerative Disease and Lumbar Degenerative Disc Disease, run by Rush University Medical Center at 1 site in United States.
Trial summary
This study aimed to investigate a novel technique for intraoperative quantitative and qualitative feedback during discectomy and endplate preparation in TLIF. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Degenerative Disease, Lumbar Degenerative Disc Disease, Degenerative Spine
- What is being tested?
- ISOVUE 300 Observation and ISOVUE 300 Feedback
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2019to 19 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing open circumferential transforaminal lumbar interbody fusion or midline cortical TLIF for degenerative spondylolisthesis
Who cannot join
- All not in the group above
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: 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.
Read the 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.
- Being tested
- ISOVUE 300 Observation, ISOVUE 300 Feedback
- Keywords
- isovue, iodinated contrast
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISOVUE 300 ObservationProcedure or surgery
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 FeedbackProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: ISOVUE 300 Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anteroposterior Plane Clearance
Disc space clearance in the anteroposterior (AP) plane at the index level measured on oblique radiographs.
Measured: Immediately after Discectomy
Mediolateral Plane Clearance
Disc space clearance in the mediolateral (ML) plane as measured by oblique radiographs.
Measured: Immediately after Discectomy/Excision Intraoperatively
Visual Analog Scale
Visual Analog Scale survey assessing leg pain and back pain
Measured: First Postoperative Clinic Appointment (within first 6 weeks)
Secondary outcomes (5)
Lumbar Lordosis
Lumbar Lordosis as measured by oblique radiographs.
Measured: Immediately after Discectomy Intraoperatively
Pelvic Incidence
Pelvic incidence (PI) as measured by oblique radiographs.
Measured: Immediately after Discectomy Intraoperatively
Disc Height
Disc height at the index level as identified by oblique radiographs.
Measured: Immediately after Discectomy Intraoperatively
Oswestry Disability Index
Oswestry Disability Index survey describing disability as a result of spinal conditions.
Measured: First Postoperative Clinic Appointment (within first 6 weeks)
Short Form Survey
SF-12 survey asking patient views about health
Measured: First Postoperative Clinic Appointment (within first 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start11 Apr 2019
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lumbar Degenerative DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363759
- Sponsor's protocol ID
- 18072502-IRB02
- Acronym
- ISOVUE
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will consider sharing if contacted with reasonable requests.
Publications
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.
PubMed 28647584Lan 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.
PubMed 29367001Katuch 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.
PubMed 34463112Reitman 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.
PubMed 23873608
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ISOVUE Contrast for Intraoperative Assessment of Discectomy Quality in TLIF: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07363759
- Acronym / sponsor ID
- ISOVUE / 18072502-IRB02
- Keywords
- isovue, iodinated contrast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Observation | Placebo comparator | Procedure: ISOVUE 300 ObservationIn 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. |
| Feedback | Experimental | Procedure: ISOVUE 300 FeedbackIn 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing open circumferential transforaminal lumbar interbody fusion or midline cortical TLIF for degenerative spondylolisthesis
Key exclusion criteria (1 listed)
- All not in the group above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISOVUE 300 ObservationIn 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 or surgery | Observation |
| ISOVUE 300 FeedbackIn 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 or surgery | Feedback |
Primary outcome
Anteroposterior Plane Clearance
Time frame: Immediately after Discectomy
Disc space clearance in the anteroposterior (AP) plane at the index level measured on oblique radiographs.
Mediolateral Plane Clearance
Time frame: Immediately after Discectomy/Excision Intraoperatively
Disc space clearance in the mediolateral (ML) plane as measured by oblique radiographs.
Visual Analog Scale
Time frame: First Postoperative Clinic Appointment (within first 6 weeks)
Visual Analog Scale survey assessing leg pain and back pain
5 secondary outcomes
Lumbar Lordosis
Time frame: Immediately after Discectomy Intraoperatively
Pelvic Incidence
Time frame: Immediately after Discectomy Intraoperatively
Disc Height
Time frame: Immediately after Discectomy Intraoperatively
Oswestry Disability Index
Time frame: First Postoperative Clinic Appointment (within first 6 weeks)
Short Form Survey
Time frame: First Postoperative Clinic Appointment (within first 6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Background: PubMed 28647584de 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.
- Background: PubMed 29367001Lan 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.
- Background: PubMed 34463112Katuch 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.
- Background: PubMed 23873608Reitman 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.
- Individual participant dataSharing planned: No. The investigators will consider sharing if contacted with reasonable requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISOVUE 300 Observation and ISOVUE 300 Feedback in people with Lumbar Degenerative Disease and Lumbar Degenerative Disc Disease, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anteroposterior Plane Clearance (time frame: Immediately after Discectomy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07363759, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.