Ten-year survival and clinical outcome of the AcroFlex lumbar disc replacement for the treatment of symptomatic disc degeneration

Abstract Background context We have previously reported on the osseointegration, stability, and preserved motion of the AcroFlex lumbar disc replacement (LDR) in a nonhuman primate model. Detailed biomechanical testing of the device predicted implant survival for at least 10 years of in vivo use. Significant improvements in the clinical outcome were reported at 2 years. However, mechanical failure of the polyolefin rubber was detected by fine-cut computed tomography (CT) in a number of subjects within 2 years. As a result, no further devices were implanted. Purpose To report on the 10-year survival and clinical outcome of the AcroFlex elastomeric LDR when used for the treatment of one- or two-level symptomatic disc degeneration between L4 and S1. Study design Prospective nonrandomized clinical trial with a mean 10-year follow-up. Patient sample Twenty-eight patients with symptomatic disc degeneration who underwent AcroFlex LDR at one or two levels. Outcome measures Clinical: Visual Analog Score for back pain, Oswestry Disability Index (ODI), Low Back Outcome Score (LBOS), and Short Form-36 (SF-36). Survival: Kaplan-Meier analysis over 10 years with first revision surgery as the end point. Radiographic: Dynamic flexion/extension radiographs at 2 years. Magnetic resonance imaging (MRI) and CT scans at 10 years. Methods Twenty-eight subjects (14 male, mean age 41 years) with symptomatic disc degeneration unresponsive to nonsurgical treatment were enrolled into a prospective nonrandomized trial of the AcroFlex LDR. Visual analog score for back pain, ODI, LBOS, and SF-36 questionnaires were administered preoperatively at 6 months, 1, 2, and 10 years after the index procedure. All subjects were invited to undergo an MRI and for those with the device remaining in situ, a lumbar CT scan. Kaplan-Meier survival analysis was performed with first revision surgery as the end point. Results At a mean of 9 years, 8 months (range, 8 years, 8 months–11 years, 3 months) after surgery, 17 of 28 patients did not require a revision surgery, representing a cumulative survival of 60.7%. In contrast, 11 of 28 patients (39.3%) underwent a total of 14 revision procedures; 9 of 11 patients underwent a conversion to anterior lumbar interbody fusion supplemented with pedicle screw fixation. Indications for a revision included device failure in seven and disabling pain in four patients. Mean time to revision was 3 years, 10 months (range, 23 months–8 years, 4 months). Mean ODI at 10 ye