Stand-alone ALIF with integrated intracorporeal anchoring plates in the treatment of degenerative lumbar disc disease: a prospective study on 65 cases

Abstract

Purpose ALIF with cages is expected to restore disc height and stabilize the spine promoting fusion, while avoiding damage attributed to rod-pedicle screw fixation. However, it may be related to an increased risk of fusion failure and subsidence. A prospective study was conducted by five investigators across three centers to confirm performance of a PEEK cage for stand-alone ALIF in the treatment of lumbar degenerative disc disease (DDD). Methods Sixty-five patients, with back ± leg pain, requiring surgery for DDD, were included. Efficacy and safety were evaluated at 6 weeks, 3, 6, and 12 months postoperatively. Fusion and subsidence were assessed through CT-images at 12-month follow-up. Disc height was measured. Clinical outcomes included back and leg pain (VAS), disability (Oswestry Disability Index), Quality of Life (Short-Form 36), and adverse events. Results The fusion and the subsidence rates were 96.3 and 2.0 %, respectively. ALIF surgery restored anterior and posterior disc height compared to baseline. There were no device-related serious adverse events, and no revision surgeries. Clinical outcomes improved significantly through 12-month follow-up. Conclusion Safety and efficacy of this stand-alone cage with integrated intracorporeal plates was confirmed through 12 months for treatment of degenerative conditions. The design of the cage and plates may contribute to the decreased subsidence rate observed.

Outcome of Anterior Lumbar Interbody Fusion: A Retrospective Study of Clinical and Radiologic Parameters

“…Almost 62% of them returned to work postoperatively, although they were preoperatively unable to work due to lumbar problems for more than three months. Although this study is inherently biased by its retrospective character and by the use of a telephone interview, the presented results are very similar as compared to the prospectively conducted papers recently published by Rao et al [5] and Allain et al [6] The M A N U S C R I P T…”

Evolution of Design of Interbody Cages for Anterior Lumbar Interbody Fusion

“…More recently, an investigation of 32 ALIF procedures performed using the SynFix system with recombinant human bone morphogenetic protein‐2 demonstrated solid fusion in 29 patients (90.6%) at 6‐month follow‐up, similar to values reported for ALIF with posterior instrumentation and bone morphogenetic protein‐2. In another recent study of stand‐alone ALIF with PEEK, a fusion rate of 96.3% was demonstrated at 12‐month follow‐up in 65 patients with degenerative lumbar disc disease. These preliminary studies provide promising results for integral fixation cages for stand‐alone ALIF; these findings require further confirmation by additional long‐term follow‐up studies.…”

Applying the Mini-Open Anterolateral Lumbar Interbody Fusion with Self-Anchored Stand-Alone Polyetheretherketone Cage in Lumbar Revision Surgery

“…In addition, the VAS and ODI scores decreased significantly after surgery compared to baseline. Studies by Siepe et al [3] and Allain et al [28] have shown similar results with significant improvement in disc height and foraminal height and decrease in VAS and ODI scores at each time point of follow-up after surgery. Subsidence of the implant into the vertebral endplate may lead to progressive lumbar deformity and recurrence of foraminal stenosis and neurological symptoms, which have been of concern to researchers.…”

“…A biomechanical test revealed that the self-locking stand-alone cage could provide immediate stability that was equivalent to that with anterior plate or posterior pedicle screw fixation [27]. Clinical studies have also demonstrated that a high fusion rate (90.6% to 97.3%) with good clinical results could be achieved using these self-anchored designed stand-alone cages [3, 25, 28]. In our study all patients achieved solid fusion at the last follow-up which supported the hypothesis that these self-anchored stand-alone cages could provide immediate stability after surgery and reach high fusion rate.…”

“…The subsidence rate has varied in different studies using a self-anchor stand-alone cage without posterior fixation. In the study by Allain et al, 1 out of 51 analyzed cases experienced subsidence at a 12-month follow-up using cages similar to those we used [28]. Behrbalk et al reported that 16% (5/32) of cases of subsidence were observed with ALIF using another kind of self-anchor stand-alone cage (SynFix-LR) without posterior instrumentation [30, 31].…”