Table 2. Summary table of RCTs comparing fusion with lumbar TDR with risk of adverse events and quality of AE reporting.
| Study (year) | Devicea | Industry funded | Fusion | TDR | RR | 95% CI | Methods clarity score | Reporting results score | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AEs (n) | Subjects (n) | Risk (%) | AEs (n) | Subjects (n) | Risk (%) | Lower | Upper | ||||||
| 2-y studies | |||||||||||||
| Berg (2009) | Charité ProDisc Maverick |
No | 15 | 72 | 20.8 | 14 | 80 | 17.5 | 1.2 | 0.62 | 2.3 | 5 | 4 |
| Blumenthal (2005) | Charité | Yes | 10 | 99 | 10.1 | 20 | 205 | 9.8 | 1.0 | 0.50 | 2.1 | 2 | 3 |
| Delmarter (2011) | ProDisc-L | No | 7 | 72 | 9.7 | 5 | 165 | 3.0 | 3.2 | 1.1 | 9.8 | 2 | 3 |
| Zigler (2007) | ProDisc-L | Yes | 5 | 75 | 6.7 | 4 | 161 | 2.5 | 2.7 | 0.73 | 9.6 | 2 | 3 |
| Gornet (2011) | Maverick | Yes | 22 | 172 | 12.8 | 17 | 405 | 4.2 | 3.0 | 1.7 | 5.6 | 2 | 4 |
| Total/mean | 59 | 490 | 12.0 | 60 | 1,016 | 5.9 | 2.0 | 1.4 | 2.9 | ||||
| 5-y studies | |||||||||||||
| Skold (2013) | Charité ProDisc Maverick |
No | 15 | 71 | 21.1 | 14 | 80 | 17.5 | 1.2 | 0.63 | 2.3 | 0 | 2 |
| Zigler (2012) | ProDisc-L | Yes | 8 | 75 | 10.7 | 5 | 161 | 3.1 | 3.4 | 1.2 | 10.1 | 3 | 4 |
| Total/mean | 23 | 146 | 15.8 | 19 | 241 | 7.9 | 2.0 | 1.1 | 3.5 | 2.3 | 3.3 | ||
Abbreviations: AE, adverse event; CI, confidence interval; RCT, randomized controlled trial; RR, relative risk; TDR, total disk replacement.
a
Charité, Depuy Spine, Raynham, Massachusetts, United States; ProDisc, Synthes Spine, West Chester, Pennsylvania, United States; Maverick, Medtronic, Memphis, Tennessee, United States.