Why Lumbar Synthetic Disk Replacements (LADRs) Fail.
Clin Backbone Surg. 2017 Jul;30(6):E743-E747
Authors: Pettine Okay, Ryu R, Techy F
STUDY DESIGN: A retrospective evaluate of prospectively collected knowledge.
OBJECTIVE: To find out why synthetic disk replacements (ADRs) fail by analyzing outcomes of 91 sufferers in FDA research carried out at a single investigational machine exemption (IDE) website with minimal 2-year follow-up.
SUMMARY OF BACKGROUND DATA: Sufferers following lumbar ADR typically obtain their 24-month follow-up outcomes at Three months postoperatively.
MATERIALS AND METHODS: Each affected person present process ADR at 1 IDE website by 2 surgeons was evaluated for medical success. Failure was outlined as <50% enchancment in ODI and VAS or any extra surgical procedure at index or adjoining backbone movement phase. Three ADRs have been evaluated: Maverick, 25 sufferers; Charité, 31 sufferers; and Kineflex, 35 sufferers. All procedures have been 1-level operations carried out at L4-L5 or L5-S1. Demographics and inclusion/exclusion standards have been comparable and will probably be mentioned.
RESULTS: General medical failure occurred in 26% (24 of 91 sufferers) at 2-year follow-up. Medical failure occurred in: 28% (Maverick) (7 of 25 sufferers), 39% (Charité) (12 of 31 sufferers), and 14% (Kineflex) (5 of 35 sufferers). Causes of failure included aspect pathology, 50% of failure sufferers (12 of 24). Implant issues occurred in 5% of whole sufferers and 21% of failure sufferers (5 of 24). Solely 5 sufferers went from a hit to failure after Three months. Just one affected person went from a failure to success after a aspect rhizotomy 1 yr after ADR.
CONCLUSIONS: Seventy-four % of sufferers after ADR met strict medical success after 2-year follow-up. The medical success versus failure price didn’t change from their Three-month follow-up in 85 of the 91 sufferers (93%). General medical success could also be improved most by affected person choice and implant kind.
PMID: 28632563 [PubMed – indexed for MEDLINE]