Single Neurosurgeon Experience with the ZimVie LDR-C ROI Implant: A Study of 236 Patients with Predictive Outcome Modeling

Author(s): Rami Elsabeh, B.S., John C. Abrahams, Barry I. Krosser, M.D., John M. Abrahams, M.D

Study Design:

Retrospective Review

Objective:

The goal of the study is to show the device has acceptable performance and fusion rates with a predictive modeling analysis of poor outcomes.

Summary of Background Data:

This is one of the larger single-surgeon studies using the same (ZimVie LDR-C ROI) stand-alone device in the treatment of cervical degenerative disease with an Anterior Cervical Diskectomy and Fusion (ACDF).

Methods:

We reviewed the records of 236 patients over a 4-year period (2016 – 2020) including presentation, diagnosis, risk factors, outcome, Odom’s Criteria, fusion status, and complication rate up to one year. We identified risk factors and performed a predictive modeling analysis for poor outcomes.

Results:

Patients presented with radiculopathy (72%) or myelopathy (28%). Surgery included one-level (45.3%), two-level (47.8%) and threelevel fusions (6.8%) with a total 384 levels. Three patients (1.2%) developed a wound hematoma; 11 (4.7%) patients had a prior fusion that needed re-exploration for possible pseudoarthrosis, and 13 (5.5%) developed adjacent segment disease. Odom’s Criteria Scores for patients at 2 weeks, 1 month, 3 months and 1 year with an outcome of Excellent to Good were 68%, 74%, 78% and 89% respectively. Fusion rates at 1 month, 3 months, and 1-year were 33%, 69% and 92%. Predictive modeling showed that outcome in the short-term was fair to poor with a pre-operative history of motor deficit or narcotics history for pain. Fair to poor outcome in the long-term one was related to a history or worker’s compensation injury, narcotics history for pain, and emotional lability.

Conclusion:

The ZimVie LDR-C ROI is a safe device with low complication rate, commensurate fusion rate, and acceptable outcome scores.