Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:47 AM
Study NCT ID:
NCT07363759
Status:
COMPLETED
Last Update Posted:
2026-01-23
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ISOVUE Comparative Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2023-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-14', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-01-14', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anteroposterior Plane Clearance', 'timeFrame': 'Immediately after Discectomy', 'description': 'Disc space clearance in the anteroposterior (AP) plane at the index level measured on oblique radiographs.'}, {'measure': 'Mediolateral Plane Clearance', 'timeFrame': 'Immediately after Discectomy/Excision Intraoperatively', 'description': 'Disc space clearance in the mediolateral (ML) plane as measured by oblique radiographs.'}, {'measure': 'Visual Analog Scale', 'timeFrame': 'First Postoperative Clinic Appointment (within first 6 weeks)', 'description': 'Visual Analog Scale survey assessing leg pain and back pain'}], 'secondaryOutcomes': [{'measure': 'Lumbar Lordosis', 'timeFrame': 'Immediately after Discectomy Intraoperatively', 'description': 'Lumbar Lordosis as measured by oblique radiographs.'}, {'measure': 'Pelvic Incidence', 'timeFrame': 'Immediately after Discectomy Intraoperatively', 'description': 'Pelvic incidence (PI) as measured by oblique radiographs.'}, {'measure': 'Disc Height', 'timeFrame': 'Immediately after Discectomy Intraoperatively', 'description': 'Disc height at the index level as identified by oblique radiographs.'}, {'measure': 'Oswestry Disability Index', 'timeFrame': 'First Postoperative Clinic Appointment (within first 6 weeks)', 'description': 'Oswestry Disability Index survey describing disability as a result of spinal conditions.'}, {'measure': 'Short Form Survey', 'timeFrame': 'First Postoperative Clinic Appointment (within first 6 weeks)', 'description': 'SF-12 survey asking patient views about health'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['isovue', 'iodinated contrast'], 'conditions': ['Lumbar Degenerative Disease', 'Lumbar Degenerative Disc Disease', 'Degenerative Spine']}, 'referencesModule': {'references': [{'pmid': '28647584', 'type': 'BACKGROUND', 'citation': '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': '29367001', 'type': 'BACKGROUND', 'citation': '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': '34463112', 'type': 'BACKGROUND', 'citation': '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': '23873608', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate a novel technique for intraoperative quantitative and qualitative feedback during discectomy and endplate preparation in TLIF.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing open circumferential transforaminal lumbar interbody fusion or midline cortical TLIF for degenerative spondylolisthesis\n\nExclusion Criteria:\n\n* All not in the group above'}, 'identificationModule': {'nctId': 'NCT07363759', 'acronym': 'ISOVUE', 'briefTitle': 'ISOVUE Comparative Trial', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'ISOVUE Contrast for Intraoperative Assessment of Discectomy Quality in TLIF: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '18072502-IRB02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Observation', 'description': '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.', 'interventionNames': ['Procedure: ISOVUE 300 Observation']}, {'type': 'EXPERIMENTAL', 'label': 'Feedback', 'description': '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.', 'interventionNames': ['Procedure: ISOVUE 300 Feedback']}], 'interventions': [{'name': 'ISOVUE 300 Observation', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Observation']}, {'name': 'ISOVUE 300 Feedback', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The investigators will consider sharing if contacted with reasonable requests.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}