Table 1 Summary of clinical and radiographic outcomes after lumbar TDR in DDD

Park et al. [7]

2016

Retrospective case series

2

54

120

69

ProDisc II

VAS and ODI improved significantly

ROM and LL improved only in monosegmental TDR

5 reoperations

–

–

Guyer et al. [8]

2016

Prospective, randomized, controlled, multicenter study

1

394

60

394

Kineflex-L

VAS and ODI improved significantly, 96,8% satisfaction

4° ROM, 0% subsidence, 77.8% HO

24 reoperations

–

–

Garcia et al. [9]

2015

Prospective, multicenter, randomized, controlled study

1

324

24

324

activL

67% ODI and 74% back pain improvement

ROM and disc height improvement, 1.6% HO

6.9% back/leg pain and 1.4% implant subsidence

–

–

Schätz ert al. [10]

2015

Multicenter, single arm, prospective, cohort study

2

83

24

121

M6-L

VAS and ODI improved significantly, no difference between SL and ML

No difference in terms of ROM between SL and ML

–

–

–

Assaker et al. [11]

2015

Prospective, multicenter, observational study

2

134

24

146

Maverick

VAS, ODI and SF-36 improved significantly

>3° of motion (extension–flexion) at the implant level

57 (42%) patients experienced complications

–

–

Lee et al. [12]

2015

Retrospective case series

4

74

60

54

ProDisc-L

–

–

Higher incidence of peritoneal injuries, retrograde ejaculation, superficial abdominal infection

–

Better perioperative outcomes but same revision rate as TLIF

Lu et al. [13]

2015

Retrospective case series

4

35

144

35

Charité III

VAS and ODI improved significantly

ROM significant decrease, IDH no difference, LL significant improvement

71.4% HO, 9.4% subsidence

–

–

Tohmeh et al. [14]

2015

Prospective, multicenter cohort study

2

64

36

64

XL TDR

VAS, ODI and SF-36 improved significantly

IDH increase, 1.6%

subsidence, ROM

5.9°, 10.3% HO

No intraoperative complications, no revision surgery

–

–

Lu et al. [15]

2015

Retrospective case series

4

30

29

36

activ-L

VAS and ODI improved significantly

ROM and IDH

improved significantly

2 tears of iliac vein,

10% subsidence, 3.3% HO

–

–

Trincat et al. [16]

2015

Retrospective case series

4

108

48

216

ProDisc-L

VAS and ODI improved significantly

ROM improved significantly but less at L5/S1

Complication rate 18%

–

–

Aghayev et al. [17]

2014

Retrospecti- ve case series

4

218

60

305

–

VAS and EQ-5D improved significantly

Average ROM 9.7°, 16.7% grade III HO

Overall 23.4%, intraoperative 4.4%, postoperative 3.2%, revision rate 4%, 10.7% ASD

–

–

Guyer et al. [18]

2014

Prospective, randomized, controlled multicenter study

1

457

24

457

Kineflex-L Disc and Charité

VAS and ODI improved significantly, no difference between 2 groups

ROM improved significantly, ROM >4° in 65.4% vs 62.5%, subsidence 0% vs 0.6%

Revision rate 10.3% vs 8.4%, 71.1% AE

–

–

Siepe et al. [19]

2014

Prospective, single-center clinical investigation of TDR

2

181

89

212

ProDisc II

VAS and ODI improved significantly

–

Complication rate 14.4%, revision rate 7.2%

–

–

Lazennec et al. [20]

2014

Prospective cohort of patients

2

46

24

46

LP-ESP

VAS, ODI and GHQ28 improved significantly

ROM improved significantly, MCR

73% ideal positioning

–

Sagittal balance (SS, PT, SL) did not change significantly at any point

of the F-U

–

Strube et al. [21]

2013

Prospective cohort study

2

40

60

40

Maverick

VAS and ODI improved significantly

>Clinical scores correlated with >IDH and >LL

–

–

–

Skold et al. [22]

2013

Prospective randomized controlled trial

1

152

60

115

Charité, ProDisc, Maverick

VAS, ODI, EQ5D and SF36 improved significantly

–

No difference in complication and revision rate between the 2 groups

–

VAS and ODI improved significantly, but less than TDR group

Oktenoglu et al. [23]

2013

Prospective clinical study

2

50

29

25

Maverick

VAS and ODI improved significantly

No difference in terms of LL and segmental lordosis angles

–

–

No difference in radiological outcomes between TDR and TLIF

Meir et al. [24]

2013

Prospective non-randomi zed clinical trial

2

28

116

32

AcroFlex

VAS, ODI, LBOS, SF-36 improved significantly

HO 85%, subsidence 14%

Revision rate 39.3%, ASD 68%

–

–

Zigler et al. [25]

2012

Prospective, randomized, multicenter study

1

236

60

161

ProDisc-L

SF-36, ODI and neurological success improved significantly

ROM preserved and good radiographic outcomes

Revision rate 6.8%, 5.1% AE

–

TDR was not inferior to fusion in terms of effectiveness and safety

Jones et al. [26]

2012

Retrospective case series

4

25

34

31

Charité

OPS and SF36v2 improved significantly

Average DHR 78.3%

–

–

–

Siepe et al. [27]

2012

Prospecrtive cohort study

2

51

50

51

ProDisc II

VAS and ODI improved significantly

Preoperative DSH 6.8mm

–

DDD had a negative correlation with DHS and Pfirmann classification

–

Van de Kelft et al. [28]

2012

Prospective cohort study

2

50

48

50

Maverick

ODI and SF36 improved significantly

Motion was preserved at the operated level

0% revision rate, no major complications

–

–

Park et al. [29]

2012

Retrospective clinical data analysis

4

42

72

51

ProDisc-L

VAS , ODI and SF36 improved significantly

–

–

–

–

Berg et al. [30]

2011

Randomized controlled trial

1

152

24

115

Charité, ProDisc, Maverick

Excellent pain relief in 70% of patients

Motion was preserved in 85% of patients

–

DH and ASD unchanged

Surgical goal was more frequently reached in the TDR group

Scott-Young et al. [31]

2011

Prospective single-center case cohort study

2

122

44.9 ± 23.3

122

Charité

VAS, ODI, SF36 and RMDQ improved significantly

HO 4.9%, optimal placement 94%, average ROM 8.6° ± 3.5°

3.3% revision rate, 0% ASD, subsidence 6.5%

–

–

Blondel et al. [1]

2011

Prospective cohort study

2

221

30

221

–

VAS and ODI improved significantly

Lower scores in patients with Modic 1

9.5% revision rate

–

–

Pettine et al. [32]

2011

Prospective, randomized non- inferiority trial

1

64

24

64

Kineflex Disc and Charité

With both devices VAS and ODI improved significantly

–

0% revision rate

–

–

Rischke et al. [33]

2011

Prospective cohort study

2

50

24

50

Viscoelastic total disc replacement Axiomed

VAS and ODI improved significantly

DH, DA, LL and ROM are maintained

0% device expulsion or fracture

–

–

Pellet [34]

2011

Prospective cohort study

2

99

24

–

Maverick

–

–

–

SSA increased significantly; spine tilt angle was 90°

Significantly more balanced spinal position than ALIF

Katsimihas et al. [35]

2010

Prospective study

2

64

55

64

Charité III

VAS , ODI and SF36 improved significantly

Sagittal rotation 6.5°, subsidence 1.7mm, IT 1.1mm

4.7% early complications, 3.1% revision rate

–

–

Yue et al. [36]

2010

Prospective, randomized, single- masked,

1

414

24

414

Activ-L Disc, Charité and ProDisc-L

VAS and ODI improvement equivalent to control group

ROM conservation equivalent to control group

Safety equivalent to control group

–

–

Siepe et al. [37]

2009

Prospective clinical study

2

161

48

189

ProDisc II

VAS and ODI improved significantly

–

–

–

–

Berg et al. [38]

2009

Prospective, randomised controlled study

1

152

24

80

–

VAS, ODI, SF36 and EQ5D improved significantly

–

Revision rate 10% (mean cause ASD)

–

Effectiveness and safety comparable to fusion group

Sinigaglia et al. [39]

2009

Prospective non- randomized

2

36

39

36

ProDisc II and Maverick

VAS, SF36 and ODI improved significantly

–

Complication rate 80.6%, L4-L5 > L5- S1

–

–

Di Silvestre et al. [40]

2009

Retrospective case series

4

32

36

48

Charité III

VAS, SF36 and ODI improved significantly, with no significant difference between two groups

No significant difference in disc height and ROM improvement between two groups

Complication rate 2-level TDR > 1- level, revision rate 12.5%, no ASD

–

–

Guyer et al. [41]

2009

Randomized controlled trial

1

133

60

90

Charité

VAS, SF36 and ODI improved significantly

ROM, DH, STR improved significantly

–

–

No difference in clinical and radiographic outcomes, TDR has greater rate of employment and lower of long-term disability than ALIF

Guyer et al. [42]

2008

Retrospective case series

4

203

24

203

Charité and ProDisc

Length of time off work is related to VAS and ODI improvement

–

–

–

–

Zigler et al. [43]

2008

Retrospective case series

4

86

24

118

ProDisc

VAS and ODI improved significantly with no difference in two groups

–

-

–

–

Hannibal et al. [44]

2007

Retrospective case series

4

59

24

91

ProDisc

VAS, SF36 and ODI improved significantly with no difference in two groups

–

–

–

–

Zigler et al. [45]

2007

Prospective, randomized, multicenter

1

286

24

211

ProDisc-L

VAS, SF36 and ODI improved significantly

93.7% ROM maintained (average 7.7°)

No major complications

–

Clinical outcomes TDR> fusion

Siepe et al. [46]

2007

Prospective cohort study

2

99

26

119

ProDisc II

VAS and ODI improved significantly, better improvement at L4–L5

–

Complication rate significantly higher in bisegmental TDR

–

–

David et al. [47]

2007

Retrospective clinical and radiographic study

4

106

134

106

Charité

Good result 82.1%, return to work 89.6%

ROM maintained 90.6%, 10.1° and 4.4°

2.8% subsidence, 2.8% ASD with reoperation

–

–

Zigler et al. [48]

2007

prospective, randomized trial

1

157

36

178

ProDisc-L

VAS and ODI improved significantly

–

–

–

No significant difference in clinical outcome between the two groups

Holt et al. [49]

2007

Prospective, randomized, multicenter

1

304

24

205

Charité

–

–

75.6% incidence, 3.4% subsidence, 5.4% revision rate

–

No worse complication rate of TDR than ALIF

Geisler et al. [50]

2007

Multicenter, prospective, randomized

1

304

24

205

Charité

VAS and ODI improved significantly

–

–

–

Better clinical improvement of TDR than ALIF

Tournier et al. [51]

2007

Retrospective case series

3

184

31.2

125

Charité, ProDisc and Maverick

–

ROM improvement <2°, MCR did not depend on the prosthesis Offcentering DH improved but decreased when the prosthesis was offcentered, no difference among type of prostheses

–

PI, PT, SS and TK didn’t change significantly after surgery, LL changed significantly after surgery

–

Siepe et al. [52]

2006

Prospective cohort study

2

92

34.2

108

ProDisc II

VAS, ODI and SF36 improved significantly (better in 1-

level TDR)

–

Higher complication rate in bisegmental TDR, overall

19.6%, revision rate 10.9%

–

–

Chung et al. [53]

2006

Prospective cohort study

2

36

24

47

ProDiscII

VAS and ODI improved significantly

DH and ROM improved significantly. Higher postoperative ROM is correlated with better clinical outcome

No major complications

–

–

Chung et al. [54]

2006

Retrospective case series

4

26

30

37

ProDisc

–

The mean ROM at L5-S1 and L4-5 increased significantly from 7.1° to 11.2 ° and from 11.4° to 14.6°

–

LL improved significantly, ST and PT didn’t change significantly

–

Huang et al. [55]

2006

Retrospective radiographic and chart review

4

42

102

60

ProDisc

VAS and ODI are not significantly better in patients without ASD

–

24% ASD

A clear relationship between TDR ROM and the presence of ASD (<5°)

–

Bertagnoli et al. [56]

2006

Prospective non-randomized clinical series

2

104

24

104

ProDisc

VAS and ODI improved significantly in both groups without difference

DH and ROM increased significantly in both groups without difference

–

–

–

Putzier et al. [57]

2006

Retrospective clinical–radiological study

4

71

204

84

Charité

VAS and ODI improved significantly

ASD 17%

Revision rate 11%

–

–

Bertagnoli et al. [58]

2005

Prospective cohort study

2

118

24

118

ProDisc

VAS and ODI improved significantly

DH and ROM increased significantly

No device-related and three approach-related complications

–

–

Bertagnoli et al. [59]

2005

Prospective cohort study

2

25

24

63

ProDisc

VAS and ODI improved significantly

DH and ROM increased significantly

1 case of subsidence, 1 case of anterior extrusion of a polyethylene component

–

–

McAfee et al. [60]

2005

Prospective, randomized, multicenter

1

304

24

205

Charité

Clinical outcomes correlated with surgical technical accuracy

ROM correlated with surgical technical accuracy

Significantly less subsidence in TDR than ALIF

–

ROM and DH improved significantly better in TDR than ALIF

Blumenthal et al. [61]

2005

Prospective, randomized, multicenter

1

304

24

205

Charité

VAS, ODI and SF36 improved significantly

–

Better revision rate for TDR than ALIF (5.4 vs 9.1%)

–

Clinical outcomes, patient satisfaction and hospital stay were significantly better

in TDR than ALIF

Lemaire et al. [62]

2005

Retrospective case series

4

100

135

147

Charité

91.6% patients returned to work

2 cases of subsidence, 51.5% DH increased, one case of height loss, mean ROM 10.3° and 5.4°

5 cases of reoperation, 2 neurologic complications, one sexual disfunction, 2 ASD

–

–

Tropiano et al. [63]

2005

Prospective cohort study

2

55

104

78

ProDisc

VAS, ODI and Stauffer- Coventry score improved significantly

No cases of subsidence or DH loss

Seven patients underwent additional surgical procedures, complication rate 9%

–

–

Guyer et al. [64]

2004

Prospective randomized clinical trial

1

144

24

100

Charité

VAS and ODI improved significantly in both groups

No subsidence, 1 case of HO

Three patients underwent additional surgical procedures

–

No significant difference in effectiveness and safety between TDR and BAK cages