Study design: Prospective observational cohort study.
Objective: The aim of this study was to determine the long-term clinical results and prosthesis survival in patients treated with lumbar total disc replacement (TDR).
Summary of background data: Fusion has become the current standard surgical treatment for lumbar degenerative disease. TDR is an alternative treatment that seeks to avoid fusion-related adverse events, specifically adjacent segment disease.
Methods: Sixty-eight consecutive patients treated with TDR from 2003 to 2008 were invited to follow-up and complete a Visual Analog Scale (VAS) for back and leg pain, the Dallas Pain Questionnaire (DPQ), and the Short Form-36. These surveys were also administered to the subjects before their index TDRs. Data on reoperation were collected from the patients' medical records.
Results: Fifty-seven (84%) patients were available for follow-up at a mean 10.6 years post-operatively (range 8.1-12.6 years). There was a significant improvement from preop to latest follow-up in VAS (6.8 vs. 3.2, P < 0.000) and DPQ (63.2 vs. 45.6, P = 0.000) in the entire cohort. Nineteen patients (33%) had a revision fusion surgery after their index TDR. Patients who had revision surgery had statistically significant worse outcome scores at last follow-up than patients who had no revision. Thirty patients (52.6%) would choose the same treatment again if they were faced with the same problem.
Conclusion: This study demonstrated significant improvement in long-term clinical outcomes, similar to previously published studies, and two-thirds of the discus prostheses were still functioning at follow-up. However, there is still a lack of well-designed long-term studies, thus requiring further investigation.
Level of evidence: 3.