Prospective, multicenter clinical trial comparing the M6-C compressible cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 5-year results of an FDA investigational device exemption study

医学 颈椎前路椎间盘切除融合术 试验装置豁免 临床终点 背景(考古学) 外科 临床试验 颈部疼痛 生活质量(医疗保健) 随机对照试验 内科学 颈椎 古生物学 替代医学 护理部 病理 生物
作者
Frank M. Phillips,Domagoj Coric,Rick Sasso,Todd H. Lanman,William F. Lavelle,Carl Lauryssen,Todd J. Albert,Frank P. Cammisa,R. Alden Milam
出处
期刊:The Spine Journal [Elsevier]
卷期号:24 (2): 219-230 被引量:1
标识
DOI:10.1016/j.spinee.2023.10.020
摘要

BACKGROUND CONTEXT : Various total disc replacement (TDR) designs have been compared to anterior cervical discectomy and fusion (ACDF) with favorable short and long-term outcomes in FDA-approved investigational device exemption (IDE) trials. The unique design of M6-C, with a compressible viscoelastic nuclear core and an annular structure, has previously demonstrated favorable clinical outcomes through 24 months. PURPOSE : To evaluate the long-term safety and effectiveness of the M6-C compressible artificial cervical disc and compare to ACDF at 5 years. STUDY DESIGN : Prospective, multicenter, concurrently and historically controlled, FDA-approved IDE clinical trial. PATIENT SAMPLE : Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and received M6-C (n = 160) or ACDF (n = 189) treatment as part of the IDE study. Safety outcomes were evaluated at 5 years for all subjects. The primary effectiveness endpoint was available at 5 years for 113 M6-C subjects and 106 ACDF controls. OUTCOME MEASURES : The primary endpoint of this analysis was composite clinical success (CCS) at 60 months. Secondary endpoints were function and pain (Neck Disability Index, VAS), physical quality of life (SF-36, SF-12), safety, neurologic, and radiographic assessments. METHODS : Propensity score subclassification was used to control for selection bias and match baseline covariates of the control group to the M6-C subjects. Sixty-month CCS rates were estimated for each treatment group using a generalized linear model controlling for propensity score. RESULTS : At 5 years post-operatively, the M6-C treatment resulted in 82.3% CCS while the ACDF group showed 67.0% CCS (superiority p = 0.013). Secondary endpoints indicated that significantly more M6-C subjects achieved VAS neck and arm pain improvements and showed maintained or improved physical functioning on quality of life measures compared to baseline assessments. The M6-C group maintained flexion-extension motion, with significantly greater increases from baseline disc height and disc angle than observed in the control group. The rates of M6-C subsequent surgical interventions (SSI; 3.1%) and definitely device- or procedure-related serious adverse events (SAE failure; 3.1%) were similar to ACDF rates (SSI = 5.3%, SAE failure = 4.8%; p > 0.05 for both). CONCLUSIONS : Subjects treated with the M6-C artificial disc demonstrated superior 5-year achievement of clinical success when compared to ACDF controls. In addition, significantly more subjects in the M6-C group showed improved pain and physical functioning scores than observed in ACDF subjects, with no difference in re-operation rates or safety outcomes.
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