Burkhard Rischke1, Kari B Zimmers2, Eric Smith2. 1. Center of Excellence for Dynamic Spine Arthroplasty, Zürich, Switzerland. 2. AxioMed LLC, Garfield Heights, Ohio, USA.
Abstract
BACKGROUND: Lumbar disc degeneration (LDD) is one of the most frequently diagnosed spinal diseases. The symptoms these disorders cause are anticipated to increase as the population in Western countries ages. PURPOSE: Compare back and leg pain alleviation in patients with LDD and a viscoelastic disc prosthesis documented in the SWISSspine registry versus patients with anterior lumbar interbody fusion documented in the Spine Tango registry. STUDY DESIGN: Prospectively collected clinical and outcome data in two independent spine registries. Outcome Measures were back and leg pain relief on 0 to 10 numerical rating scales. MATERIALS AND METHODS: The analysis included a single surgeon series of 48 patients with viscoelastic total disc replacement (VTDR) from the SWISSspine registry which were compared to 131 patients with anterior lumbar interbody fusion (ALIF) from the Spine Tango registry. Two linear multivariate regression models were built to assess the associations of patient characteristics with back and leg pain relief. The following covariates were included in the models: patient age and sex, disc herniation as additional diagnosis, number of treated segments, level of treated segment, treatment type (VTDR, ALIF), preoperative back and leg pain levels and follow-up interval. RESULTS: Both models showed VTDR to be associated with significantly higher back (2.76 points; 95% confidence interval (CI) 1.78 - 3.73; p < 0.001) and leg pain (2.12 points; 95% CI 1.12 to 3.13; p < 0.001) relief than ALIF. Other influential factors for higher back pain relief were female sex compared with male sex (1.03 additional points; 95% CI 0.27 to 1.78; p = 0.008), monosegmental surgery compared with bisegmental surgery (1.02 additional points; 95% CI 0.21 to 1.83; p = 0.014), and higher back pain at baseline (0.87 points additional pain relief per level of preoperative back pain; 95% CI 0.70 to 1.03; p < 0.001). Other influential factors for leg pain relief were monosegmental surgery (0.93 additional points; 95% CI 0.10 to 1.77; p = 0.029) and higher leg pain at baseline (0.83 points additional pain relief per level of preoperative leg pain; 95% CI 0.70 to 0.96). In both models the L3/4 segment showed 2.36 points (95% CI -4.27 to -0.45; p = 0.016) and 3.69 points (95% CI -5.66 to -1.71; p < 0.001) less pain relief than L5/S1. DISCUSSION: Significantly higher back and leg pain relief were observed after viscoelastic total disc replacement in comparison with anterior lumbar interbody fusion. The new less rigid materials used in the second generation total disc replacements (TDRs) may make artificial disc replacement an increasingly attractive option for patients with degenerative lumbar disc disease. Further controlled and long-term follow-up studies are required for more detailed comparisons of the outcomes of these types of disc implants. The Freedom Lumbar Disc is limited by U.S. federal law to investigational use only.
BACKGROUND: Lumbar disc degeneration (LDD) is one of the most frequently diagnosed spinal diseases. The symptoms these disorders cause are anticipated to increase as the population in Western countries ages. PURPOSE: Compare back and leg pain alleviation in patients with LDD and a viscoelastic disc prosthesis documented in the SWISSspine registry versus patients with anterior lumbar interbody fusion documented in the Spine Tango registry. STUDY DESIGN: Prospectively collected clinical and outcome data in two independent spine registries. Outcome Measures were back and leg pain relief on 0 to 10 numerical rating scales. MATERIALS AND METHODS: The analysis included a single surgeon series of 48 patients with viscoelastic total disc replacement (VTDR) from the SWISSspine registry which were compared to 131 patients with anterior lumbar interbody fusion (ALIF) from the Spine Tango registry. Two linear multivariate regression models were built to assess the associations of patient characteristics with back and leg pain relief. The following covariates were included in the models: patient age and sex, disc herniation as additional diagnosis, number of treated segments, level of treated segment, treatment type (VTDR, ALIF), preoperative back and leg pain levels and follow-up interval. RESULTS: Both models showed VTDR to be associated with significantly higher back (2.76 points; 95% confidence interval (CI) 1.78 - 3.73; p < 0.001) and leg pain (2.12 points; 95% CI 1.12 to 3.13; p < 0.001) relief than ALIF. Other influential factors for higher back pain relief were female sex compared with male sex (1.03 additional points; 95% CI 0.27 to 1.78; p = 0.008), monosegmental surgery compared with bisegmental surgery (1.02 additional points; 95% CI 0.21 to 1.83; p = 0.014), and higher back pain at baseline (0.87 points additional pain relief per level of preoperative back pain; 95% CI 0.70 to 1.03; p < 0.001). Other influential factors for leg pain relief were monosegmental surgery (0.93 additional points; 95% CI 0.10 to 1.77; p = 0.029) and higher leg pain at baseline (0.83 points additional pain relief per level of preoperative leg pain; 95% CI 0.70 to 0.96). In both models the L3/4 segment showed 2.36 points (95% CI -4.27 to -0.45; p = 0.016) and 3.69 points (95% CI -5.66 to -1.71; p < 0.001) less pain relief than L5/S1. DISCUSSION: Significantly higher back and leg pain relief were observed after viscoelastic total disc replacement in comparison with anterior lumbar interbody fusion. The new less rigid materials used in the second generation total disc replacements (TDRs) may make artificial disc replacement an increasingly attractive option for patients with degenerative lumbar disc disease. Further controlled and long-term follow-up studies are required for more detailed comparisons of the outcomes of these types of disc implants. The Freedom Lumbar Disc is limited by U.S. federal law to investigational use only.
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