Clinical and radiographic outcomes with L4-S1 axial lumbar interbody fusion (AxiaLIF) and posterior instrumentation: a multicenter study.

Med Devices (Auckl). 2013;6:155-161

Authors: Tobler WD, Melgar MA, Raley TJ, Anand N, Miller LE, Nasca RJ

INTRODUCTION: Previous studies have confirmed the benefits and limitations of the presacral retroperitoneal approach for L5-S1 interbody fusion. The purpose of this study was to determine the safety and effectiveness of the minimally invasive axial lumbar interbody approach (AxiaLIF) for L4-S1 fusion.
METHODS: In this retrospective series, 52 patients from four clinical sites underwent L4-S1 interbody fusion with the AxiaLIF two-level system with minimum 2-year clinical and radiographic follow-up (range: 24-51 months). Outcomes included back pain severity (on a 10-point scale), the Oswestry Disability Index (ODI), and Odom’s criteria. Flexion and extension radiographs, as well as computed tomography scans, were evaluated to determine fusion status. Longitudinal outcomes were assessed with repeated measures analysis of variance.
RESULTS: Mean subject age was 52 ± 11 years and the male:female ratio was 1:1. Patients sustained no intraoperative bowel or vascular injury, deep infection, or neurologic complication. Median procedural blood loss was 220 cc and median length of hospital stay was 3 days. At 2-year follow-up, mean back pain had improved 56%, from 7.7 ± 1.6 at baseline to 3.4 ± 2.7 (P < 0.001). Back pain clinical success (ie, ≥30% improvement from baseline) was achieved in 39 (75%) patients at 2 years. Mean ODI scores improved 42%, from 60% ± 16% at baseline to 35% ± 27% at 2 years (P < 0.001). ODI clinical success (ie, ≥30% improvement from baseline) was achieved in 26 (50%) patients. At final follow-up, 45 (87%) patients were rated as good or excellent, five as fair, and two as poor by Odom’s criteria. Interbody fusion observed on imaging was achieved in 97 (93%) of 104 treated interspaces. During follow-up, five patients underwent reoperation on the lumbar spine, including facet screw removal (two), laminectomy (two), and transforaminal lumbar interbody fusion (one).
CONCLUSION: The AxiaLIF two-level device is a safe, effective treatment adjunct for patients with L4-S1 disc pathology resistant to conservative treatments.

PMID: 24092998 [PubMed – as supplied by publisher]

Retrieval of a migrated Axialif lumbosacral screw using fluoroscopic guidance with simultaneous real-time sigmoidoscopy; technical report.
Spine (Phila Pa 1976). 2013 Sep 15;38(20):E1285-7
Authors: Wilson J, Timothy A, Rao J…

Rectal perforation after AxiaLIF instrumentation: case report and review of the literature.
Spine J. 2013 Aug 24;
Authors: Mazur MD, Duhon BS, Schmidt MH, Dailey AT

Radiographic and clinical outcome after 1- and 2-level transsacral axial interbody fusion.

J Neurosurg Spine. 2013 Aug 23;

Authors: Hofstetter CP, Shin B, Tsiouris AJ, Elowitz E, Härtl R

Object The paracoccygeal approach allows for instrumentation of L5/S1 and L4/5 by using a transsacral rod (AxiaLIF; TransS1, Inc.). The authors analyzed clinical and radiographic outcomes of 1- or 2-level AxiaLIF procedures with focus on durability of the construct. Methods This was a retrospective study of 38 consecutive patients who underwent either 1-level (32 patients) or 2-level (6 patients) AxiaLIF procedures at the authors’ institution. The Oswestry Disability Index (minimum clinically important difference [MCID] ≥ 12) and visual analog scale ([VAS]; MCID ≥ 3) scores were collected. Disc height and Cobb angles were measured on pre- and postoperative radiographs. Bony fusion was determined on CT scans or flexion/extension radiographs. Results Implantation of a transsacral rod allowed for intraoperative distraction of the L5/S1 intervertebral space and resulted in increased segmental lordosis postoperatively. At a mean follow-up time of 26.2 ± 2.4 months, however, graft subsidence (1.9 mm) abolished partial correction of segmental lordosis. Moreover, subsidence of the construct reduced L5/S1 lordosis in patients with 1-level AxiaLIF by 3.2° and L4-S1 lordosis in patients with 2-level procedures by 10.1° compared with preoperative values (p < 0.01). Loss of segmental lordosis predicted failure to improve VAS scores for back pain in the patient cohort (p < 0.05). Overall, surgical intervention led to modest symptomatic improvement; only 26.3% of patients achieved an MCID of the Oswestry Disability Index and 50% of patients an MCID of the VAS score for back pain. At last follow-up, 71.9% of L5/S1 levels demonstrated bony fusion (1-level AxiaLIF 80.8%, 2-level AxiaLIF 33.3%; p < 0.05), whereas none of the L4/5 levels in 2-level AxiaLIF fused. Five constructs developed pseudarthrosis and required surgical revision. Conclusions The AxiaLIF procedure constitutes a minimally invasive technique for L5/S1 instrumentation, with low perioperative morbidity. However, the axial rod provides inadequate long-term anterior column support, which leads to subsidence and loss of segmental lordosis. Modification of the transsacral technique to allow for placement of a solid interposition graft may counteract subsidence of the construct.

PMID: 23971765 [PubMed – as supplied by publisher]

Axial lumbar interbody fusion: a 6-year single-center experience.

Clin Interv Aging. 2013;8:1063-9

Authors: Zeilstra DJ, Miller LE, Block JE

INTRODUCTION: The aim of this study is to report our 6-year single-center experience with L5-S1 axial lumbar interbody fusion (AxiaLIF).
METHODS: A total of 131 patients with symptomatic degenerative disc disease refractory to nonsurgical treatment were treated with AxiaLIF at L5-S1, and were followed for a minimum of 1 year (mean: 21 months). Main outcomes included back and leg pain severity, Oswestry Disability Index score, working status, analgesic medication use, patient satisfaction, and complications. Computed tomography was used to determine postoperative fusion status.
RESULTS: No intraoperative complications, including vascular, neural, urologic, or bowel injuries, were reported. Back and leg pain severity decreased by 51% and 42%, respectively, during the follow-up period (both P < 0.001). Back function scores improved 50% compared to baseline. Clinical success, defined as improvement ≥30%, was 67% for back pain severity, 65% for leg pain severity, and 71% for back function. The employment rate increased from 47% before surgery to 64% at final follow-up (P < 0.001). Less than one in four patients regularly used analgesic medications postsurgery. Patient satisfaction with the AxiaLIF procedure was 83%. The fusion rate was 87.8% at final follow-up. During follow-up, 17 (13.0%) patients underwent 18 reoperations on the lumbar spine, including pedicle screw fixation (n = 10), total disc replacement of an uninvolved level (n = 3), facet screw fixation (n = 3), facet screw removal (n = 1), and interbody fusion at L4-L5 (n = 1). Eight (6.1%) reoperations were at the index level.
CONCLUSION: Single-level AxiaLIF is a safe and effective means to achieve lumbosacral fusion in patients with symptomatic degenerative disc disease.

PMID: 23976846 [PubMed – in process]

Axial lumbosacral interbody fusion appears safe as a method to obtain lumbosacral arthrodesis distal to long fusion constructs.
HSS J. 2012 Jul;8(2):116-21
Authors: Issack PS, Boachie-Adjei O

Safety and effectiveness of retrorectal presacral approach for lumbosacral axial instrumentation. A clinical study.
Acta Orthop Belg. 2013 Apr;79(2):222-9
Authors: Hadjipavlou A, Alpantaki K, Katonis P, Vastardis G, Tzermiad…

Rectocutaneous fistula and nonunion after TranS1 axial lumbar interbody fusion L5-S1 fixation.
J Neurosurg Spine. 2013 Jun 21;
Authors: Siegel G, Patel N, Ramakrishnan R
The authors report a case of …

Retrieval of a migrated Axialif lumbosacral screw using fluoroscopic guidance with simultaneous real-time sigmoidoscopy; technical report.
Spine (Phila Pa 1976). 2013 Jun 17;
Authors: Wilson J, Timothy A, Rao J, Sagar PM

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