Low Reoperation Rate After Cervical Total Disc Replacement With ProDisc-C

ISASS19 Meeting Highlight

Peer Reviewed

A large consecutive case series of patients undergoing cervical total disc replacement with the ProDisc-C device over a 15-year period at a single institution showed a relatively low overall reoperation rate of 5.5%, Jack E. Zigler, MD, FACS, FAAOS, said at the International Society for the Advancement of Spine Surgery (ISASS) 19th Annual Conference held April 3 to 5, 2019 in Anaheim, CA.

Lateral x-ray of a cervical spineLateral x-ray of a cervical spine. Photo Source: 123RF.com.

“No secondary surgeries were required in this series for device failure, which I think is a great finding,” Dr. Zigler said. “Therefore, the results strongly support the safety of the ProDisc-C device.”

When evaluating the safety of an implant, there are two important factors to consider, Dr. Zigler told attendees. These factors are 1) the rate of subsequent reoperation; and 2) the reasons for reoperation, particularly those that are possibly device related.

Dr. Zigler and colleagues examined the reoperation rate in a large consecutive case series of the first 504 patients who underwent cervical total disc replacement with the ProDisc-C implant at single center over 15 years, beginning in 2003 when the first Investigational Device Exemption trials of this device were performed. All patients had at least 2 years of post-operative follow-up data available by December 2017.

The majority of patients (n=463; 92%) underwent a single-level cervical disc replacement. An additional 39 patients (8%) received 2-level cervical disc replacement, and 2 patients underwent 3-level intervention. This case series included 112 hybrid procedures (implant plus anterior cervical discectomy and fusion [ACDF]), which represent off-label uses of the device.

Low Rate of Reoperation Found With the ProDisc-C Device

Secondary surgeries occurred in 28 patients (5.5%). Notably, no reoperations were performed because of ProDisc-C device failure, Dr. Zigler emphasized.

Twenty of the reoperations were performed for adjacent segment degeneration, with 5 of these being adjacent to fusion levels. Three patients had ProDisc-C removal and underwent subsequent ACDF for migration, subsidence, and spondylosis (one case each).

Additionally, reoperations were performed for repositioning of the ProDisc-C in 1 patient, wound infection in 1 patient, subcutaneous hematoma drainage in 1 patient, and spinal cord stimulator placement for persistent pain in 2 patients.

A majority of the reoperations (25 cases) were performed ≥10 months after the index surgery. Three reoperations (10.7%) occurred within one month of the index surgery due to wound infection, repositioning, and hematoma. The mean duration between cervical total disc replacement and secondary surgery was approximately 3.5 years, Dr. Zigler said.

Repositioning Case

In the repositioning case, “the patient was discharged the day after the index surgery with right arm pain, but thought the pain was tolerable and wanted to go home,” Dr. Zigler said. “The next day, he called and said his right arm pain was getting worse, and he reported tingling in his fingers. Imaging suggested foraminal encroachment on the right side.”

The ProDisc-C device was repositioned at 6-days post-index surgery. At 6 months after repositioning, the patient reported no neck pain (0 out of 10) and minimal right arm pain (1.3 out of 10).

Study Strengths and Weaknesses

The strengths of the study include its single-center design, which eliminates many of the surgical and data collection variables that exist in multicenter analyses, Dr. Zigler said. While most of the surgeons at the center are experienced in anterior cervical surgery, for many surgeons the ProDisc-C was the first cervical arthroplasty device that they were exposed to. Thus, there was a learning curve for use of the ProDisc-C device. “In some ways, this may represent the worst-case scenario,” Dr. Zigler noted.

Limitations of the study include reoperations what could have been performed elsewhere. However, if reoperations were performed at a different site, “the device manufacturer would have been alerted (FDA reporting) and notified us. This did not occur,” Dr. Zigler said.

Disclosure
Dr. Zigler has received teaching and consulting fees from Centinel Spine, Medtronic, Orthofix, and Simplify.

 

Updated on: 05/16/19
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Cervical Total Disc Replacement and Routine Osteoporosis Screening
Jack E. Zigler, MD, FACS, FAAOS
Orthopaedic Spine Surgeon
Texas Back Institute
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