RESUMEN
BACKGROUND: The objective of this study was to correlate various radiological parameters with clinical outcome in patients who had undergone lumbar total disc replacement (TDR). Lumbar TDR is one possible treatment option in patients with low back pain (LBP), offering an alternative to lumbar fusion. Favourable clinical outcome hinges on a number of radiological parameters, such as mobility, sintering, and-most importantly-accurate positioning of the implant. METHODS: A total of 46 patients received a prosthetic disc because of degenerative lumbar disc disorders. Follow-up evaluation included analysis of radiographs and subjective rating of the clinical status by the patient using the North American Spine Society (NASS) patient questionnaire, visual analogue scale (VAS) for pain and state of health, and the EuroQol EQ-5D. Radiological follow-up took place after 2 years. Coronal and sagittal positions of the prosthesis, intervertebral disc height, facet joint pressure, mobility, sintering, and calcification were evaluated. Optimal positioning of the prosthesis was defined as a central coronal position and a most dorsal position in the sagittal plane. Based on the radiologically determined placement of the prosthesis, the patient population was divided into three groups, i.e., prosthesis ideally placed (<2 mm), discretely shifted (2-3 mm), or suboptimally placed (>3 mm). RESULTS: Overall, 81 % of patients stated that they would undergo the operation again. Health status was stable at a VAS score of 7.04 points 2 years after TDR, compared to 3.97 points before TDR. Mean working capacity had increased from 53 % preoperatively to 88 % 2 years after TDR. Overall, 39 % of the prostheses were rated as ideally positioned, while 13 % were discretely shifted and 48 % were suboptimally placed with respect to one of the radiological criteria. In 80.4 % of patients, follow-up assessment after ≥2 years indicated good mobility at the operated segment, while calcification was noted in 4 % and sintering was detected in 15 % of the implants. CONCLUSIONS: Our data indicate poor correlation between clinical outcome and position of the prosthesis. Although 48 % of the implants were suboptimally placed in either the coronal or sagittal plane, most of the patients reached a very good clinical outcome. However, suboptimally placed devices appeared to cause significantly more neurological symptoms in long-term follow-up.