Medical expertise and two-year follow-up with a one-piece viscoelastic cervical whole disc alternative.
J Backbone Surg. 2017 Dec;three(four):630-640
Authors: Chin KR, Lubinski JR, Zimmers KB, Sands BE, Pencle F
Background: The aim of this research is to current scientific end result knowledge from a 2-year post-market research of a viscoelastic one-piece cervical whole disc alternative (TDR) in Europe.
Strategies: Thirty-nine sufferers have been implanted at 5 surgical websites in an European post-market scientific research. Medical outcomes included enchancment of neck incapacity index (NDI) and visible analog scale scores for neck and arm ache from baseline to 2-year follow-up, neurological examinations, sufferers view on the success of surgical procedure, issues, and subsequent surgical interventions.
Outcomes: Thirty sufferers had the Freedom® Cervical Disc (FCD) implanted at a single stage, and 9 sufferers have been implanted at two adjoining ranges. The inhabitants had the same distribution of male  and feminine  topics, with a imply age of 45 years. All self-administered end result measures confirmed important clinically necessary enhancements from baseline to the 2-year follow-up. Imply preoperative NDI rating improved from 48% to 20%, 13%, eight%, 6% and four% at 6 weeks, three, 6, 12, and 24 months, respectively. Common preoperative visible analog scale (VAS) scores of the neck, proper and left arm ache depth and frequency confirmed important enchancment. All neurological end result measurements confirmed fast enchancment from preoperative values and continued enchancment all through 2 years follow-up. From pre-op to 24 months, neurological deficits declined within the inhabitants from 21% to six% for reflex perform, 62% to 17% for sensory perform, and 38% to three% for motor perform. No sufferers skilled a deterioration in any measured outcomes in contrast with the preoperative state of affairs. Affected person satisfaction elevated over 2 years post-op, with 83% of sufferers responding that they might “positively” select to have the identical therapy for his or her neck/arm situation and one other 11% responding that they might “most likely” select to have the identical therapy.
Conclusions: The FCD performs as anticipated in sufferers with single-level and two-level degenerative disc illness.
PMID: 29354742 [PubMed]