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This study aimed to investigate a novel technique for intraoperative quantitative and qualitative feedback during discectomy and endplate preparation in TLIF.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28647584 | Background | 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. | |
| 29367001 |
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The investigators will consider sharing if contacted with reasonable requests.
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
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|
| 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. |
|
| 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) |
| 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. |
| 34463112 | 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. |
| 23873608 | 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. |