Scott-Young Matthew, Nielsen David, Riar Sukhman, Rathbone Evelyne
Faculty of Health Science and Medicine, Bond University, 27 Garden Street, Southport, Gold Coast, QLD, 4215, Australia.
Gold Coast Spine, Gold Coast, QLD, 4215, Australia.
Eur Spine J. 2025 May 28. doi: 10.1007/s00586-025-08926-6.
Periprosthetic osteolysis from the M6-C™ Artificial Cervical Disc (Orthofix, Lewisville, Texas) has become a significant issue, sometimes requiring revision spine surgery (RSS). This study evaluates patient-reported outcome measures (PROMs) and revision strategies for managing device-related wear and osteolysis.
PROMs, including the Visual Analogue Scale (VAS) for neck/arm pain and the Neck Disability Index (NDI), were analyzed at pre-index surgery (T1), pre-RSS (T2), and final follow-up (T3). Osteolysis severity was graded radiographically. A control group who underwent primary M6-C cervical total disc replacement (CTDR) without RSS was included for comparison.
Of 53 patients with M6-C CTDR, 19 (35.9%) required RSS due to osteolysis. Osteolysis grades included Grade 1 (4 patients), Grade 2 (7 patients), Grade 3 (3 patients), and Grade 4 (5 patients). Revision strategies included removal and anterior fusion, requiring vertebrectomy for Grade 4 cases; revisions to a different CTDR prosthesis were reserved for Grades 1-3. The RSS group showed significant VAS neck pain improvement at T3 (mean = 36.2 points, p < 0.001), exceeding the minimum clinically important difference (MCID). However, VAS arm pain and NDI did not meet MCID thresholds. The control group showed clinically significant improvements across all PROMs. At T2, the RSS group had a higher disability (NDI, p = 0.027) than the controls.
Revision surgery for M6-C osteolysis improves neck pain, not arm pain or disability. Early detection and tailored revision strategies are crucial to optimize patient outcomes and mitigate osteolysis-related disability.
M6-C™人工颈椎间盘（美国德克萨斯州刘易斯维尔市的Orthofix公司生产）引起的假体周围骨溶解已成为一个重要问题，有时需要进行翻修脊柱手术（RSS）。本研究评估患者报告的结局指标（PROMs）以及处理与器械相关的磨损和骨溶解的翻修策略。
在索引手术前（T1）、翻修脊柱手术前（T2）和最终随访时（T3）分析PROMs，包括颈部/手臂疼痛视觉模拟量表（VAS）和颈部功能障碍指数（NDI）。通过影像学对骨溶解严重程度进行分级。纳入一组未进行RSS的初次M6-C颈椎全椎间盘置换术（CTDR）患者作为对照组进行比较。
在53例行M6-C CTDR的患者中，19例（35.9%）因骨溶解需要进行RSS。骨溶解分级包括1级（4例患者）、2级（7例患者）、3级（3例患者）和4级（5例患者）。翻修策略包括取出并前路融合，4级病例需要进行椎体切除；1-3级病例则翻修为不同的CTDR假体。RSS组在T3时VAS颈部疼痛有显著改善（平均=36.2分，p<0.001），超过了最小临床重要差异（MCID）。然而，VAS手臂疼痛和NDI未达到MCID阈值。对照组在所有PROMs方面均有临床显著改善。在T2时，RSS组的功能障碍（NDI，p=0.027）高于对照组。
M6-C骨溶解的翻修手术可改善颈部疼痛，但不能改善手臂疼痛或功能障碍。早期检测和定制的翻修策略对于优化患者预后和减轻骨溶解相关的功能障碍至关重要。
