BACKGROUND: Many first generation stand-alone fusion cages required endplate decortication and surgical impaction during the procedure resulting in segmental subsidence, implant migration and loss of lordosis postoperatively. The primary objective of this study was to evaluate radiographically, in a large series of patients, whether engineering and design modifications incorporated in a specific stand-alone, expandable interbody fusion device (VariLift(®)-L) adequately addressed previously recognized deficiencies of stand-alone interbody cages. METHODS: In this retrospective chart review of 470 patients (642 treated levels), we evaluated radiographic evidence of fusion, subsidence and migration following a one- or two-level PLIF procedure utilizing this stand-alone expandable interbody fusion device. A secondary objective was to corroborate the low morbidity and symptomatic improvements achieved with previous interbody cage devices used to treat symptomatic disc degeneration. RESULTS: The average postoperative followup was 3.9 ± 1.8 years and a solid fusion rate of 94% was achieved among patients with ≥ 9 months of radiographic followup. Subsidence > 3 mm was noted at 10 levels with no cases of device migration. Composite back pain severity scores improved from 8.5 ± 1.5 preoperatively to 0.8 ± 1.5 at final followup (p<0.001) and 94% of patients met or exceeded the minimal clinical important difference of 3.8 points. Eighteen patients required reoperation following the index procedure; 16 of these patients were treated for adjacent segment disease. CONCLUSIONS LOE: The VariLift-L device has excellent clinical and technical performance characteristics, providing adequate stabilization of the anterior column without the need for supplemental posterior instrumentation. Level of Evidence IV. IRB Approval: Expedited Federal Register Categories 5& 7: Methodist IRB 3/30/2011; Informed Consent statement: retrospective data collection, patients signed consent forms allowing for data to be used for research. CLINICAL RELEVANCE: This stand-alone expandable fusion device produced high fusion rates, a low incidence of reoperation and effective symptom relief in a "real world" setting among a large group of patients with refractory symptomatic disc degeneration.
BACKGROUND: Many first generation stand-alone fusion cages required endplate decortication and surgical impaction during the procedure resulting in segmental subsidence, implant migration and loss of lordosis postoperatively. The primary objective of this study was to evaluate radiographically, in a large series of patients, whether engineering and design modifications incorporated in a specific stand-alone, expandable interbody fusion device (VariLift(®)-L) adequately addressed previously recognized deficiencies of stand-alone interbody cages. METHODS: In this retrospective chart review of 470 patients (642 treated levels), we evaluated radiographic evidence of fusion, subsidence and migration following a one- or two-level PLIF procedure utilizing this stand-alone expandable interbody fusion device. A secondary objective was to corroborate the low morbidity and symptomatic improvements achieved with previous interbody cage devices used to treat symptomatic disc degeneration. RESULTS: The average postoperative followup was 3.9 ± 1.8 years and a solid fusion rate of 94% was achieved among patients with ≥ 9 months of radiographic followup. Subsidence > 3 mm was noted at 10 levels with no cases of device migration. Composite back pain severity scores improved from 8.5 ± 1.5 preoperatively to 0.8 ± 1.5 at final followup (p<0.001) and 94% of patients met or exceeded the minimal clinical important difference of 3.8 points. Eighteen patients required reoperation following the index procedure; 16 of these patients were treated for adjacent segment disease. CONCLUSIONS LOE: The VariLift-L device has excellent clinical and technical performance characteristics, providing adequate stabilization of the anterior column without the need for supplemental posterior instrumentation. Level of Evidence IV. IRB Approval: Expedited Federal Register Categories 5& 7: Methodist IRB 3/30/2011; Informed Consent statement: retrospective data collection, patients signed consent forms allowing for data to be used for research. CLINICAL RELEVANCE: This stand-alone expandable fusion device produced high fusion rates, a low incidence of reoperation and effective symptom relief in a "real world" setting among a large group of patients with refractory symptomatic disc degeneration.
Authors: Rakesh D Patel; Gregory P Graziano; Kelly L Vanderhave; Alpesh A Patel; Michael C Gerling Journal: Spine (Phila Pa 1976) Date: 2011-12-15 Impact factor: 3.468
Authors: Fred H Geisler; Scott L Blumenthal; Richard D Guyer; Paul C McAfee; John J Regan; J Patrick Johnson; Bradford Mullin Journal: J Neurosurg Spine Date: 2004-09