Introduction
Materials and methods
Criteria for selecting studies for the meta-analysis
Types of studies
Types of participants
Types of interventions
Types of outcomes studied
Search strategy and selection criteria
Data extraction and management
Risk of bias assessment
GRADE approach
Data analysis
Measures of treatment effect
Assessment of heterogeneity
Subgroup analysis
Bias of publication
Results
Description of the studies
References | Design | Intervention | Patients | Level | Age(years) | FU (months) | ASDeg | ASDis | Reoperation | Qualitya | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
F | NF | F | NF | F | NF | F | NF | F | NF | F | NF | F | NF | ||||
Phillips, F M(US) [31] | RCT (R:1:1 C:unclear B:unclear L:114/403) | ACDF | TDR (PCM) | 185 | 218 | S | S | comparable | 60 | 92 | 72 | 11 | 4 | B | |||
Davis, R J(US) [30] | RCT (R:ratio1:2 C:Yes B:patients L:18/330) | ACDF | TDR (Mobi-C) | 105 | 225 | D | D | 46.2 | 45.3 | 48 | 48 | 92 | B | ||||
Zhang, H X(CHA) [29] | RCT (R:ratio1:1 C:unclear B:unclear L:0/111) | ACDF | TDR (Mobi-C) | 56 | 55 | S | S | 46.7 | 44.8 | 48 | 4 | 0 | B | ||||
Burkus, J K(US) [28] | RCT (R:ratio1:1 C:Yes B:patients L:146/541) | ACDF | TDR (Prestige) | 265 | 276 | S | S | 43.9 | 43.3 | 84 | 10 | 8 | B | ||||
Li, Z H(CHA) [27] | RCT (R:ratio1:1 C:unclear B:unclear L:0/81) | ACDF | TDR (Scient’x) | 42 | 39 | S | S | 49.5 | 45.3 | 27 | 6 | 5 | C | ||||
Guan, T (CHA) [26] | RCT (R:ratio1:1 C:unclear B:unclear L:6/66) | ACDF | TDR (Active-c) | 34 | 32 | S | S | 52.6 | 49.6 | 34 | 21 | 13 | B | ||||
Tian, W(CHA) [25] | RCT (R:ratio1:1 C:unclear B:unclear L:30/93) | ACDF | TDR (Bryan) | 48 | 45 | S/D (23/12) | S/D (20/8) | 48.7 | 45 | 80 | 21 | 12 | B | ||||
Nunley, P D(US) [24] | RCT (R:ratio1:2 C:unclear B:Patients L:12/182) | ACDF | TDR (unclear) | 62 | 120 | S/D (43/19) | S/D (71/29) | 43 | 45 | 42 | 18 | 31 | 9 | 19 | C | ||
Coric, D(US) [23] | RCT (R:ratio1:1 C:unclear B:unclear L:35/269) | ACDF | TDR (Kineflex-C) | 133 | 136 | S | S | 43.9 | 43.7 | 24 | 68 | 42 | 5 | 1 | B | ||
Sasso, R C(US) [22] | RCT (R:ratio1:1 C:Yes B:Both L:154/463) | ACDF | TDR (Bryan) | 221 | 242 | S | S | 46.1 | 42.5 | 48 | 9 | 9 | 9 | 9 | A | ||
Jawahar, A(US) [17] | RCT (R:randomization number C:unclear B:Patients L:29/93) | ACDF | TDR (Kineflex-C/Mobi-C/Advent) | 34 | 59 | S/D (28/6) | S/D (43/16) | comparable | 37 | 6 | 9 | B |
Risk of bias in the studies
Measures of overall outcomes
Adjacent segment degeneration (ASDeg)
Adjacent segment disease (ASDis)
Subgroup analysis
FU | <5y | ≥5y | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
OR [95%CI] | P value | I2(%) | NO. of P | NO. of ASD | NO. of S | OR [95%CI] | P value | I2(%) | NO. of P | NO. of ASD | NO. of S | |
ASDeg | 0.63 [0.48, 0.84] | 0.001 | 23 | 928 | 344 | 5 | 0.49 [0.34, 0.71] | 0.0002 | 0 | 496 | 197 | 2 |
ASDis | 0.99 [0.57, 1.73] | 0.98 | 0 | 738 | 61 | 3 | – | – | – | – | – | 0 |
Reop | 0.52 [0.24, 1.13] | 0.1 | 40 | 843 | 28 | 3 | 0.51 [0.25, 1.04] | 0.07 | 35 | 944 | 33 | 2 |
SITE | U.S. | CHINA | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
OR [95%CI] | P value | I2(%) | NO. of P | NO. of ASD | NO. of S | OR [95%CI] | P value | I2(%) | NO. of P | NO. of ASD | NO. of S | |
ASDeg | 0.59 [0.46, 0.75] | 0.0001 | 44 | 1184 | 463 | 4 | 0.52 [0.29, 0.92] | 0.03 | 0 | 240 | 78 | 3 |
ASDis | 0.99 [0.57, 1.73] | 0.98 | 0 | 738 | 61 | 3 | – | – | – | – | – | 0 |
Reop | 0.56 [0.32, 0.96] | 0.03 | 11 | 1676 | 57 | 4 | 0.11 [0.01, 2.00] | 0.13 | – | 111 | 4 | 1 |
The GRADE of this meta-analysis
TDR compared to ACDF for ASD | ||||||
---|---|---|---|---|---|---|
Patient or population: patients with ASD Settings: Intervention: TDR Comparison: ACDF | ||||||
Outcomes | Illustrative comparative risksa (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
ACDF | TDR | |||||
ASD Follow-up: 24–84 months | Study population | OR 0.6 (0.49 to 0.73) | 2632 (11 studies) | ⊕ ⊕ ⊕⊝ moderate | ||
256 per 1000 | 171 per 1000 (144 to 201) | |||||
Moderate | ||||||
GRADE Working group grades of evidence | ||||||
High quality: Further research is very unlikely to change our confidence in the estimate of effect. | ||||||
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. | ||||||
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. | ||||||
Very low quality: We are very uncertain about the estimate. |
Discussion
Conclusion
Acknowledgements
Availability of data and materials
Device statement
Types of artificial discs | Manufacturer’s name | Address |
PCM | Waldemar Link GmbH & Co., KG | Barkhausenweg 10, 22339 Hamburg |
Mobi-C | LDR Medical | BP2 10902 Troyes Cedex 9 France |
Prestige | Medtronic | Memphis, TN 38132, USA |
Scient’x | Scient’x | Guyancourt Cedex France |
Active-c | Aesculap | Tuttlingen, Germany |
Bryan | Medtronic | Memphis, TN 38132, USA |
Kineflex-C | USA | USA |
Advent | / | USA |