PT  - JOURNAL ARTICLE
AU  - RIPUL PANCHAL
AU  - RYAN DENHAESE
AU  - CLINT HILL
AU  - K. BRANDON STRENGE
AU  - ALEXANDRE DE MOURA
AU  - PETER PASSIAS
AU  - PAUL ARNOLD
AU  - ANDREW CAPPUCCINO
AU  - M. DAVID DENNIS
AU  - ANDY KRANENBURG
AU  - BRIETA VENTIMIGLIA
AU  - KIM MARTIN
AU  - CHRIS FERRY
AU  - SARAH MARTINECK
AU  - CAMILLE MOORE
AU  - KEE KIM
TI  - Anterior and Lateral Lumbar Interbody Fusion With Supplemental Interspinous Process Fixation: Outcomes from a Multicenter, Prospective, Randomized, Controlled Study
AID  - 10.14444/5025
DP  - 2018 Apr 01
TA  - International Journal of Spine Surgery
PG  - 172--184
VI  - 12
IP  - 2
4099  - http://ijssurgery.com//content/12/2/172.short
4100  - http://ijssurgery.com//content/12/2/172.full
SO  - Int J Spine Surg2018 Apr 01; 12
AB  - Background: Rigid interspinous process fixation (ISPF) has received consideration as an efficient, minimally disruptive technique in supporting lumbar interbody fusion. However, despite advantageous intraoperative utility, limited evidence exists characterizing midterm to long-term clinical outcomes with ISPF. The objective of this multicenter study was to prospectively assess patients receiving single-level anterior (ALIF) or lateral (LLIF) lumbar interbody fusion with adjunctive ISPF. Methods: This was a prospective, randomized, multicenter (11 investigators), noninferiority trial. All patients received single-level ALIF or LLIF with supplemental ISPF (n = 66) or pedicle screw fixation (PSF; n = 37) for degenerative disc disease and/or spondylolisthesis (grade ≤2). The randomization patient ratio was 2:1, ISPF/PSF. Perioperative and follow-up outcomes were collected (6 weeks, 3 months, 6 months, and 12 months).Results: For ISPF patients, mean posterior intraoperative outcomes were: blood loss, 70.9 mL; operating time, 52.2 minutes; incision length, 5.5 cm; and fluoroscopic imaging time, 10.4 seconds. Statistically significant improvement in patient Oswestry Disability Index scores were achieved by just 6 weeks after operation (P < .01) and improved out to 12 months for the ISPF cohort. Patient-reported 36-Item Short Form Health Survey and Zurich Claudication Questionnaire scores were also significantly improved from baseline to 12 months in the ISPF cohort (P < .01). A total of 92.7% of ISPF patients exhibited interspinous fusion at 12 months. One ISPF patient (1.5%) required a secondary surgical intervention of possible relation to the posterior instrumentation/procedure.Conclusion: ISPF can be achieved quickly, with minimal tissue disruption and complication. In supplementing ALIF and LLIF, ISPF supported significant improvement in early postoperative (≤12 months) patient-reported outcomes, while facilitating robust posterior fusion.