Complications with axial presacral lumbar interbody fusion: A 5-year postmarketing surveillance experience

SAS Journal

Volumn 5, Issue 3, 2011, Pages 90-94

  Gundanna, Mukund I ^a   Miller, Larry E ^b,c   Block, Jon E ^c  

^a Brazos Spine   (United States)

^b Miller Scientific Consulting Inc   (United States)

^c Toyota Technical Center USA Inc   (United States)

Author keywords

AxiaLIF; Fusion; Lumbar; Minimally invasive; Presacral

Indexed keywords

ARTICLE; BLOOD VESSEL INJURY; FIXATION DEVICE; HEMATOMA; HUMAN; HYPOTENSION; INTESTINE INJURY; LUMBAR SPINE; MAJOR CLINICAL STUDY; NERVE INJURY; POSTMARKETING SURVEILLANCE; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; RECTUM INJURY; SACRAL SPINAL CORD; SACRAL SPINE FRACTURE; SPINE FRACTURE; SPINE FUSION; URETER INJURY; WOUND INFECTION;

EID: 83455213901     PISSN: None     EISSN: 19359810     Source Type: Journal    
DOI: 10.1016/j.esas.2011.03.002     Document Type: Article

References (21)

1. Deyo R.A., Gray D.T., Kreuter W., Mirza S., Martin B.I. United States trends in lumbar fusion surgery for degenerative conditions. Spine (Phila Pa 1976) 2005, 30:1441-1445. discussion 1446-47.
2. Mayer H.M. A new microsurgical technique for minimally invasive anterior lumbar interbody fusion. Spine (Phila Pa 1976) 1997, 22:691-699. discussion 700.
3. Regan J.J., Yuan H., McAfee P.C. Laparoscopic fusion of the lumbar spine: minimally invasive spine surgery. A prospective multicenter study evaluating open and laparoscopic lumbar fusion. Spine (Phila Pa 1976) 1999, 24:402-411.
4. Wang J., Zhou Y., Zhang Z.F., Li C.Q., Zheng W.J., Liu J. Comparison of one-level minimally invasive and open transforaminal lumbar interbody fusion in degenerative and isthmic spondylolisthesis grades 1 and 2. Eur Spine J 2010, 19:1780-1784.
5. 510(k) Summary: TranS1 Axial Fixation System 2004, Food and Drug Administration, Food and Drug Administration, Silver Spring (MD).
6. 510(k) Summary: TranS1 AxiaLIF II System 2008, Food and Drug Administration, Food and Drug Administration, Silver Spring (MD).
7. Marotta N., Cosar M., Pimenta L., Khoo L.T. A novel minimally invasive presacral approach and instrumentation technique for anterior L5-S1 intervertebral discectomy and fusion: technical description and case presentations. Neurosurg Focus 2006, 20:E9.
8. Summary of safety and effectiveness: BAK Interbody Fusion System with Instrumentation 1996, Food and Drug Administration, Food and Drug Administration, Silver Spring (MD).
9. Summary of safety and effectiveness: Ray Threaded Fusion Cage (TFC) with Instrumentation 1996, Food and Drug Administration, Food and Drug Administration, Silver Spring (MD).
10. Summary of safety and effectiveness: INTER FIX Threaded Fusion Device 1999, Food and Drug Administration, Food and Drug Administration, Silver Spring (MD).
11. Summary of safety and effectiveness: InFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device 2002, Food and Drug Administration, Food and Drug Administration, Silver Spring (MD).
12. Summary of safety and effectiveness: PRODISC-L Total Disc Replacement 2006, Food and Drug Administration, Food and Drug Administration, Silver Spring (MD).
13. Summary of safety and effectiveness: CHARITE Artificial Disc 2004, Food and Drug Administration, Food and Drug Administration, Silver Spring (MD).
14. Chung S.K., Lee S.H., Lim S.R., Kim D.Y., Jang J.S., Nam K.S., Lee H.Y. Comparative study of laparoscopic L5-S1 fusion versus open mini-ALIF, with a minimum 2-year follow-up. Eur Spine J 2003, 12:613-617.
15. Geerdes B.P., Geukers C.W., van Erp W.F. Laparoscopic spinal fusion of L4-L5 and L5-S1. Surg Endosc 2001, 15:1308-1312.
16. Schizas C., Tzinieris N., Tsiridis E., Kosmopoulos V. Minimally invasive versus open transforaminal lumbar interbody fusion: evaluating initial experience. Int Orthop 2009, 33:1683-1688.
17. Schwender J.D., Holly L.T., Rouben D.P., Foley K.T. Minimally invasive transforaminal lumbar interbody fusion (TLIF): technical feasibility and initial results. J Spinal Disord Tech 2005, 18(Suppl):S1-S6.
18. Nowitzke A.M. Assessment of the learning curve for lumbar microendoscopic discectomy. Neurosurgery 2005, 56:755-762. discussion 755-62.
19. Aryan H.E., Newman C.B., Gold J.J., Acosta F.L., Coover C., Ames C.P. Percutaneous axial lumbar interbody fusion (AxiaLIF) of the L5-S1 segment: initial clinical and radiographic experience. Minim Invasive Neurosurg 2008, 51:225-230.
20. Stippler M., Turka M., Gerszten P.C. Outcomes after percutaneous TranS1 AxiaLIF L5-S1 interbody fusion for intractable lower back pain. Internet J Spine Surg 2009, 5:1-12.
21. McNeil J.J., Grabsch E.A., McDonald M.M. Postmarketing surveillance: strengths and limitations. The flucloxacillin-dicloxacillin story. Med J Aust 1999, 170:270-273.