Degenerative Spine, Lumbar Degenerative Disc Disease, Lumbar Degenerative Disease
Conditions
Keywords
isovue, iodinated contrast
Brief summary
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.
Interventions
PROCEDUREISOVUE 300 Observation
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.
PROCEDUREISOVUE 300 Feedback
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.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | First Postoperative Clinic Appointment (within first 6 weeks) | Visual Analog Scale survey assessing leg pain and back pain |
| Anteroposterior Plane Clearance | Immediately after Discectomy | Disc space clearance in the anteroposterior (AP) plane at the index level measured on oblique radiographs. |
| Mediolateral Plane Clearance | Immediately after Discectomy/Excision Intraoperatively | Disc space clearance in the mediolateral (ML) plane as measured by oblique radiographs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form Survey | First Postoperative Clinic Appointment (within first 6 weeks) | SF-12 survey asking patient views about health |
| Oswestry Disability Index | First Postoperative Clinic Appointment (within first 6 weeks) | Oswestry Disability Index survey describing disability as a result of spinal conditions. |
| Disc Height | Immediately after Discectomy Intraoperatively | Disc height at the index level as identified by oblique radiographs. |
| Lumbar Lordosis | Immediately after Discectomy Intraoperatively | Lumbar Lordosis as measured by oblique radiographs. |
| Pelvic Incidence | Immediately after Discectomy Intraoperatively | Pelvic incidence (PI) as measured by oblique radiographs. |
Countries
United States
Outcome results
None listed