Progression of Adjacent-level Degeneration After Lumbar Total Disc Replacement: Results of a Post-hoc Analysis of Patients With Available Radiographs From a Prospective Study With 5-year Follow-up

腰椎全椎间盘置换术后邻近节段退变进展:一项前瞻性研究(5年随访)中可获得X线片的患者的事后分析结果

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Abstract

STUDY DESIGN: Post-hoc analysis of 5-year follow-up data from a randomized, multicenter trial. OBJECTIVE: The aim of this study was to investigate the incidence of progression in radiographic adjacent-level degeneration (ΔALD) from preoperative assessment to 5 years after total disc replacement (TDR) and the relationship of these changes with range of motion and clinical adjacent-level disease. A secondary objective was to compare adjacent-level degeneration (ALD) outcomes between TDR and fusion. SUMMARY OF BACKGROUND DATA: Fusion is associated with high rates of ALD in symptomatic lumbar disc degeneration. TDR may reduce this risk. METHODS: In total, 175 patients with single-level, symptomatic, lumbar disc degeneration who had received activL or ProDisc-L and had a preoperative and 5-year postoperative radiograph available were included. Over 5-year follow-up, ΔALD was defined as an increase in ALD of ≥1 grade and clinical ALD was defined as surgical treatment at the level adjacent to an index TDR. Matching-adjusted indirect comparisons were conducted to compare ALD outcomes after TDR (current trial) with those after fusion (published trial). RESULTS: At 5-year follow-up, 9.7% (17/175) of TDR patients had ΔALD at the superior level. In patients with preoperative ALD at the superior level, most (88% [23/26]) showed no radiographic progression over 5 years. The rate of clinical ALD was 2.3% (4/175) and none of these patients had ALD at baseline. For each degree of range of motion gained at the TDR level, there was a consistent decrease in the percentage of patients with ΔALD. After matching and adjustment of baseline characteristics, TDR had a significantly lower likelihood of ΔALD than fusion (odds ratio 0.32; 95% confidence interval 0.13, 0.76). CONCLUSION: The rates of ΔALD and clinical ALD in this TDR population were similar to those previously reported in the literature for TDR at 5-year follow-up. TDR had a significantly lower rate of ΔALD than fusion. LEVEL OF EVIDENCE: 3.

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