Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion

Abstract

<jats:sec> <jats:title>Object</jats:title> <jats:p>The authors report the 5-year results for radiographically demonstrated adjacent-level degenerative changes from a prospective multicenter study in which patients were randomized to either total disc replacement (TDR) or circumferential fusion for single-level lumbar degenerative disc disease (DDD).</jats:p></jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>Two hundred thirty-six patients with single-level lumbar DDD were enrolled and randomly assigned to 2 treatment groups: 161 patients in the TDR group were treated using the ProDisc-L (Synthes Spine, Inc.), and 75 patients were treated with circumferential fusion. Radiographic follow-up data 5 years after treatment were available for 123 TDR patients and 43 fusion patients. To characterize adjacent-level degeneration (ALD), radiologists at an independent facility read the radiographic films. Adjacent-level degeneration was characterized by a composite score including disc height loss, endplate sclerosis, osteophytes, and spondylolisthesis. At 5 years, changes in ALD (ΔALDs) compared with the preoperative assessment were reported.</jats:p></jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>Changes in ALD at 5 years were observed in 9.2% of TDR patients and 28.6% of fusion patients (p = 0.004). Among the patients without adjacent-level disease preoperatively, new findings of ALD at 5 years posttreatment were apparent in only 6.7% of TDR patients and 23.8% of fusion patients (p = 0.008). Adjacent-level surgery leading to secondary surgery was reported for 1.9% of TDR patients and 4.0% of fusion patients (p = 0.6819). The TDR patients had a mean preoperative index-level range of motion ([ROM] of 7.3°) that decreased slightly (to 6.0°) at 5 years after treatment (p = 0.0198). Neither treatment group had significant changes in either ROM or translation at the superior adjacent level at 5 years posttreatment compared with baseline.</jats:p></jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>At 5 years after the index surgery, ProDisc-L maintained ROM and was associated with a significantly lower rate of ΔALDs than in the patients treated with circumferential fusion. In fact, the fusion patients were greater than 3 times more likely to experience ΔALDs than were the TDR patients. Clinical trial registration no.: NCT00295009.</jats:p></jats:sec>

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“…Five-year results in randomized clinical trials versus fusion show that lumbar disc replacements generally reach these goals, with pain relief equal to or better than fusion, maintenance of motion at the replaced joint, and less adjacent level degeneration than observed adjacent to a fusion [1,11,13,14]. However, as is true of any joint replacement, motion between the contacting surfaces while under load causes wear with an associated release of debris that can vary in size, shape, and chemical composition depending on the materials used for the bearing surfaces, the design of the joint articulation, and the tendency for wear to occur due to unintended mechanical damage such as impingement.…”

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“…10,11 As far as I can tell this is largely, but not wholly, connected to the "Changing Degree of Pain" item, although there are minor changes to all the other questions, as seen in Fig. 1.…”