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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
56
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.
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.
Rush University Medical Center
Chicago, Illinois, United States
Anteroposterior Plane Clearance
Disc space clearance in the anteroposterior (AP) plane at the index level measured on oblique radiographs.
Time frame: Immediately after Discectomy
Mediolateral Plane Clearance
Disc space clearance in the mediolateral (ML) plane as measured by oblique radiographs.
Time frame: Immediately after Discectomy/Excision Intraoperatively
Visual Analog Scale
Visual Analog Scale survey assessing leg pain and back pain
Time frame: First Postoperative Clinic Appointment (within first 6 weeks)
Lumbar Lordosis
Lumbar Lordosis as measured by oblique radiographs.
Time frame: Immediately after Discectomy Intraoperatively
Pelvic Incidence
Pelvic incidence (PI) as measured by oblique radiographs.
Time frame: Immediately after Discectomy Intraoperatively
Disc Height
Disc height at the index level as identified by oblique radiographs.
Time frame: Immediately after Discectomy Intraoperatively
Oswestry Disability Index
Oswestry Disability Index survey describing disability as a result of spinal conditions.
Time frame: First Postoperative Clinic Appointment (within first 6 weeks)
Short Form Survey
SF-12 survey asking patient views about health
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Time frame: First Postoperative Clinic Appointment (within first 6 weeks)