Background: Total disc replacement in the lumbar spine is offered to patients with long-lasting localized low back pain secondary to degenerative disc disease, where non-operative treatment has failed. The aim of the study was to evaluate the outcome in patients offered operation with disc replacement using Prodisc II.
Material and methods: All patients that had gone through disc replacement with Prodisc II at Kysthospitalet in Hagevik during the autumn of 2003 (n = 14) were included in a time-series designed study, with repeated measures 3 times preoperative and 5 times postoperative. The last measurement was done 2 years after the operation. Questionnaires and physical performance tests were used to measure differences in function, pain, psychological factors, fear of physical activity and dynamic flexibility of the back.
Results and interpretation: Preoperative measures showed reduction in pain, depression and somatisation. The other variables were rather stable before the operation. All the variables showed significant improvement 6 months after operation. While pain and perceived functional ability improved substantially after 3 months, physical performance did not show clinically important changes until 6 months after operation. The Oswestry Disability Index (ODI) showed a 29-point mean decrease after 2 years. 11 patients demonstrated a clinically significant improvement (ODI < or =10 points) after 2 years. The effect of this operative treatment should be assessed in randomised controlled trials with a longer follow-up.