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Int J Spine Surg. 2018 Aug 03;12(2):172-184. doi: 10.14444/5025. eCollection 2018 Apr.

Anterior and Lateral Lumbar Interbody Fusion With Supplemental Interspinous Process Fixation: Outcomes from a Multicenter, Prospective, Randomized, Controlled Study.

International journal of spine surgery

Ripul Panchal, Ryan Denhaese, Clint Hill, K Brandon Strenge, Alexandre DE Moura, Peter Passias, Paul Arnold, Andrew Cappuccino, M David Dennis, Andy Kranenburg, Brieta Ventimiglia, Kim Martin, Chris Ferry, Sarah Martineck, Camille Moore, Kee Kim

Affiliations

  1. University of California Davis Health System, Sacramento, California.
  2. AXIS Neurosurgery and Spine, Williamsville, New York.
  3. The Orthopaedic Institute, Paducah, Kentucky.
  4. New York Spine Institute, Westbury, New York.
  5. Department of Neurosurgery, University of Kansas, Kansas City, Kansas.
  6. Buffalo Spine Surgery, Lockport, New York.
  7. South Texas Spinal Clinic, Laredo, Texas.
  8. Southern Oregon Orthopaedics, Medford, Oregon.
  9. Zimmer Biomet Spine, Broomfield, Colorado.
  10. RPA Consulting, Grand Island, New York.
  11. University of Colorado-Denver, Denver, Colorado.

PMID: 30276077 PMCID: PMC6159706 DOI: 10.14444/5025

Abstract

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 (

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.

Keywords: ALIF; ISPF; LLIF; MIS; anterior lumbar interbody fusion; degenerative disc disease; interspinous process fixation; lateral lumbar interbody fusion; lumbar spine; minimally invasive; posterior fixation; spondylolisthesis

Conflict of interest statement

Disclosures and COI: Institutional review board approval was obtained at each center (Western IRB, Puyallup, Washington), and informed consent was obtained from all study participants. R.P., R.D., C.H

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