Document Detail


Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion.
MedLine Citation:
PMID:  23082849     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECT: The authors report the 5-year results for radiographically demonstrated adjacent-level degenerative changes from a prospective multicenter study in which patients were randomized to either total disc replacement (TDR) or circumferential fusion for single-level lumbar degenerative disc disease (DDD).
METHODS: Two hundred thirty-six patients with single-level lumbar DDD were enrolled and randomly assigned to 2 treatment groups: 161 patients in the TDR group were treated using the ProDisc-L (Synthes Spine, Inc.), and 75 patients were treated with circumferential fusion. Radiographic follow-up data 5 years after treatment were available for 123 TDR patients and 43 fusion patients. To characterize adjacent-level degeneration (ALD), radiologists at an independent facility read the radiographic films. Adjacent-level degeneration was characterized by a composite score including disc height loss, endplate sclerosis, osteophytes, and spondylolisthesis. At 5 years, changes in ALD (ΔALDs) compared with the preoperative assessment were reported.
RESULTS: Changes in ALD at 5 years were observed in 9.2% of TDR patients and 28.6% of fusion patients (p = 0.004). Among the patients without adjacent-level disease preoperatively, new findings of ALD at 5 years posttreatment were apparent in only 6.7% of TDR patients and 23.8% of fusion patients (p = 0.008). Adjacent-level surgery leading to secondary surgery was reported for 1.9% of TDR patients and 4.0% of fusion patients (p = 0.6819). The TDR patients had a mean preoperative index-level range of motion ([ROM] of 7.3°) that decreased slightly (to 6.0°) at 5 years after treatment (p = 0.0198). Neither treatment group had significant changes in either ROM or translation at the superior adjacent level at 5 years posttreatment compared with baseline.
CONCLUSIONS: At 5 years after the index surgery, ProDisc-L maintained ROM and was associated with a significantly lower rate of ΔALDs than in the patients treated with circumferential fusion. In fact, the fusion patients were greater than 3 times more likely to experience ΔALDs than were the TDR patients. Clinical trial registration no.: NCT00295009.
Authors:
Jack E Zigler; Jamieson Glenn; Rick B Delamarter
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2012-10-19
Journal Detail:
Title:  Journal of neurosurgery. Spine     Volume:  17     ISSN:  1547-5646     ISO Abbreviation:  J Neurosurg Spine     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-03     Completed Date:  2013-02-15     Revised Date:  2014-03-18    
Medline Journal Info:
Nlm Unique ID:  101223545     Medline TA:  J Neurosurg Spine     Country:  United States    
Other Details:
Languages:  eng     Pagination:  504-11     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00295009
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MeSH Terms
Descriptor/Qualifier:
Adult
Female
Follow-Up Studies
Humans
Intervertebral Disc / radiography*,  surgery
Intervertebral Disc Degeneration / radiography*,  surgery
Lumbar Vertebrae / radiography*,  surgery
Male
Middle Aged
Spinal Fusion / methods*
Total Disc Replacement / methods*
Treatment Outcome
Comments/Corrections
Comment In:
J Neurosurg Spine. 2012 Dec;17(6):502; author response 503   [PMID:  23082847 ]
J Neurosurg Spine. 2014 Feb;20(2):241-2
J Neurosurg Spine. 2014 Feb;20(2):239-41   [PMID:  24266676 ]
J Neurosurg Spine. 2012 Dec;17(6):491; author response 492   [PMID:  23082848 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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