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Long-term Outcomes of 2-Level Total Disc Replacement Using ProDisc-L: Nine- to 10-Year Follow-up

Balderston, Jessica R. BS*; Gertz, Zachary M. MD; McIntosh, Theresa CRNP; Balderston, Richard A. MD

doi: 10.1097/BRS.0000000000000148
Outcomes

Study Design. A prospective clinical data analysis.

Objective. To determine the long-term clinical success of 2-level total disc replacement (TDR) in patients with degenerative disc disease.

Summary of Background Data. Early successful clinical results of 2-level TDR have been reported. Few studies exist that have described this procedure's durability in the long term.

Methods. Fifteen patients underwent 2-level lumbar TDR with the ProDisc-L as part of a randomized trial, 13 of whom were available for follow-up. The patients were assessed preoperatively and at 2 years, 5 years, and more than 9 years postoperatively using visual Oswestry Disability Index. At the last follow-up visit, 2 additional questions were asked: satisfaction with surgery and willingness to undergo the same treatment. Finally, clinical success was assessed using a previously described definition.

Results. Mean follow-up time was 9.6 years (range, 9.2–10.3 yr). Postoperatively there was a significant improvement in Oswestry Disability Index score from baseline (70.0 vs. 15.7 at 2 yr, P = 0.002) that remained unchanged during the period of follow-up (19.8 at 5 yr, P = 0.003 and 12.9 at 9–10 yr, P = 0.002). Ninety-two percent of patients were “satisfied” or “somewhat satisfied” with treatment and the same number would undergo treatment again. Eighty-five percent of patients achieved clinical success.

Conclusion. This prospective study demonstrates the durable clinical success of 2-level lumbar TDR as assessed at more than 9 years postoperatively.

Level of Evidence: 4

A prospective clinical study to determine the long-term clinical success of 2-level total disc replacement using ProDisc-L in patients with degenerative disc disease was conducted. In 13 patients, the short-term clinical improvements in Oswestry Disability Index scores were maintained during an average of 9.6 years of follow-up.

*Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

Virginia Commonwealth University, Richmond, VA; and

Aria 3B Orthopaedic Institute, Philadelphia, PA.

Address correspondence and reprint requests to Richard A. Balderston, MD, Aria 3B Orthopaedic Institute, 601 Walnut St, Suite L50, Philadelphia, PA 19106; E-mail: richatbald@aol.com

Acknowledgment date: July 9, 2013. Revision date: September 23, 2013. Acceptance date: November 22, 2013.

The manuscript submitted does not contain information about medical device(s)/drug(s).

No funds were received in support of this work.

Relevant financial activities outside the submitted work: consultancy.

© 2014 by Lippincott Williams & Wilkins