ISOVUE Comparative Trial

Rush

Status: Completed

Conditions: Lumbar Degenerative Disc Disease; Lumbar Degenerative Disease; Degenerative Spine

Treatments: Procedure: ISOVUE 300 Feedback; Procedure: ISOVUE 300 Observation

Study type: Interventional

Funder types: Other

Identifiers

NCT07363759

18072502-IRB02

Details and patient eligibility

About

This study aimed to investigate a novel technique for intraoperative quantitative and qualitative feedback during discectomy and endplate preparation in TLIF.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups, including a placebo group

Observation

Placebo Comparator group

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.

Treatment:

Procedure: ISOVUE 300 Observation

Feedback

Experimental group

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.

Treatment:

Procedure: ISOVUE 300 Feedback