Study Design. Prospective, randomized, single-center, clinical trial.
Objective. To prospectively examine the 7- and 10-year outcomes of cervical arthroplasty to anterior cervical discectomy and fusion (ACDF).
Summary of Background Data. Degeneration of the cervical discs causing radiculopathy is a frequent source of surgical intervention, commonly treated with ACDF. Positive clinical outcomes are associated with arthrodesis techniques, yet there remains a long-term concern for adjacent segment change. Cervical disc arthroplasty has been designed to mitigate some of the challenges associated with arthrodesis whereas providing for a similar positive neurological outcome. As data has been collected from numerous prospective US FDA IDE trials, longer term outcomes regarding adjacent segment change may be examined.
Methods. As part of an FDA IDE trial, a single center collected prospective outcomes data on 47 patients randomized in a 1:1 ratio to ACDF or arthroplasty.
Results. Success of both surgical interventions remained high at the 10-year interval. Both arthrodesis and arthroplasty demonstrated statistically significant improvements in neck disability index, visual analog scale neck and arm pain scores at all intervals including 7- and 10-year periods. Arthroplasty demonstrated an advantage in comparison to arthrodesis as measured by final 10-year NDI score (8 vs. 16, P = 0.0485). Patients requiring reoperation were higher in number in the arthrodesis cohort (32%) in comparison with arthroplasty (9%) (P = 0.055).
Conclusion. At 7 and 10 years, cervical arthroplasty compares favorably with ACDF as defined by standard outcomes scores in a highly selected population with radiculopathy.
Level of Evidence: 1
*Department of Research, Indiana Spine Group, Carmel, IN
†Indiana Spine Group, Carmel, IN.
Address correspondence and reprint requests to Joseph D. Smucker, MD, Indiana Spine Group, 13225 North Meridian Street, Carmel, IN 46032; E-mail: email@example.com
Received 13 February, 2016
Revised 10 May, 2016
Accepted 23 May, 2016
The device(s)/drug(s) is/are FDA-approved or approved by corresponding national agency for this indication.
Medtronic Sofamor Danek funds were received in support of this work.
No relevant financial activities outside the submitted work.