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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. To evaluate the long-term safety and effectiveness of the M6-C compressible artificial cervical disc and compare to ACDF at 5 years. Prospective, multicenter, concurrently and historically controlled, FDA-approved IDE clinical trial. 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. 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. 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. At 5 years postoperatively, the M6-C treatment resulted in 82.3% CCS while the ACDF group showed 67.0% CCS (superiority p=.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>.05 for both). 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 reoperation rates or safety outcomes. [ABSTRACT FROM AUTHOR]

i-FACTOR is a composite bone substitute material consisting of a P-15 synthetic collagen fragment adsorbed onto an organic bone mineral and suspended in an inert biocompatible hydrogel carrier. Previous analyses of the US FDA IDE study demonstrated the benefits of i-FACTOR compared to local autograft bone in single-level ACDF at 12- and 24-months postoperative. We report 6-year clinical and radiological outcomes of post-approval study. Subjects from a completed, prospective, randomized, controlled, multicenter clinical trial that was conducted at 22 North American sites were enrolled in a post-approval study and we report 6-year outcomes. Of 319 subjects that participated in the IDE study, 220 were enrolled into post-approval 6 years follow-up autograft (n = 114) or i-FACTOR (n = 105) in a cortical ring allograft. Radiological, clinical, and patient-reported outcomes. Subjects completed prospective, randomized, controlled, multicenter clinical trial that was conducted at 22 North American sites were enrolled into post-approval study 6 years follow-up. Fusion rates at 72 months were 99.0% in i-FACTOR subjects and 98.2% in autograft subjects, with a difference of 0.8% (95% C.I., (95% CI -2.3%, 4.0%). Mean improvement in NDI in i-FACTOR subjects was 28.56 (95% CI 24.79, 32.33) compared to 29.17 (95% CI 25.46, 32.88) in autograft subjects, with a difference of -0.61 (2.793) (95% CI -6.10, 4.88). Neurologic success rate at 72 months was 95.89% in i-FACTOR subjects and 93.33% in autograft subjects, with a difference of 2.6% (95% CI, -4.70%, 9.81%). Overall success rate was 68% in i-Factor and 62% in autograft subjects. Safety outcomes were similar between the 2 treatment groups. Secondary surgery at any cervical level occurred in 20 (18.9%) i-FACTOR subjects and 23 (20.2%) autograft subjects (p=0.866). Pain and SF-36 outcomes were similar between the groups at all study visits. There were no adverse reactions associated with i-FACTOR. At 6 years, i-FACTOR in ACDF resulted in similar outcomes compared to local autograft. Safety outcomes are acceptable and clinical and functional outcomes for i-FACTOR in the previous studies are confirmed. I-Factor (Approved for this indication) [ABSTRACT FROM AUTHOR]