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Long-term Clinical Outcomes of Cervical Disc Arthroplasty: A Prospective, Randomized, Controlled Trial.
- Source :
-
Spine [Spine (Phila Pa 1976)] 2017 Feb 15; Vol. 42 (4), pp. 209-216. - Publication Year :
- 2017
-
Abstract
- Study Design: Prospective, randomized, single-center, clinical trial.<br />Objective: To prospectively examine the 7- and 10-year outcomes of cervical arthroplasty to anterior cervical discectomy and fusion (ACDF).<br />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.<br />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.<br />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, Pā=ā0.0485). Patients requiring reoperation were higher in number in the arthrodesis cohort (32%) in comparison with arthroplasty (9%) (Pā=ā0.055).<br />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.<br />Level of Evidence: 1.
- Subjects :
- Diskectomy methods
Female
Follow-Up Studies
Humans
Male
Neck Pain etiology
Pain Measurement methods
Prospective Studies
Reoperation statistics & numerical data
Spinal Fusion methods
Time
Treatment Outcome
Arthroplasty methods
Cervical Vertebrae surgery
Intervertebral Disc surgery
Range of Motion, Articular physiology
Subjects
Details
- Language :
- English
- ISSN :
- 1528-1159
- Volume :
- 42
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Spine
- Publication Type :
- Academic Journal
- Accession number :
- 28207654
- Full Text :
- https://doi.org/10.1097/BRS.0000000000001746