Accepted Manuscript

Title: Motion preservation following total lumbar disc replacement at the

lumbosacral junction: a prospective long-term clinical and radiographic
investigation

Author: Christoph Wuertinger, Raphael Dàgostino Annes, Wolfgang Hitzl,

Christoph J. Siepe

PII: S1529-9430(17)30309-1
DOI: http://dx.doi.org/doi: 10.1016/j.spinee.2017.06.035
Reference: SPINEE 57375

To appear in: The Spine Journal

Received date: 21-11-2016

Revised date: 27-4-2017
Accepted date: 26-6-2017

Please cite this article as: Christoph Wuertinger, Raphael Dàgostino Annes, Wolfgang Hitzl,
Christoph J. Siepe, Motion preservation following total lumbar disc replacement at the
lumbosacral junction: a prospective long-term clinical and radiographic investigation, The Spine
Journal (2017), http://dx.doi.org/doi: 10.1016/j.spinee.2017.06.035.

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 Long-Term Clinical and Radiographic Analysis following TDR

1 Motion Preservation following Total Lumbar Disc Replacement

2 at the Lumbosacral Junction:
3 A Prospective Long-Term Clinical and Radiographic Investigation
4
5
6 Christoph Wuertinger, MD; 1 Raphael DÀgostino Annes, MD; 2
7 Wolfgang Hitzl, MSc, PhD; 3 Christoph J. Siepe, MD, PhD 1
8
9
10
11
12
13 1 Schön Clinic Munich Harlaching, Spine Center,
14 Academic Teaching Hospital and Spine Research Institute of the Paracelsus Medical University Salzburg (AU),
15 Harlachinger Str. 51, D-81547 Munich, Germany
16
17 2 Private Practice, Rua General Daltro Filho 481, 99074020 Passo Fundo
18
19 3 Paracelsus Medical University Salzburg, Department of Biostatistics, Research Office,
20 Strubergasse 21, 5020 Salzburg, Austria
21
22
23
24
25
26
27 Correspondence Address:
28 Christoph Würtinger; MD
29 Christoph J. Siepe; MD, PhD

30 Spine Center, Schön Clinic Munich Harlaching

31 Academic Teaching Hospital and Spine Research Institute
32 Paracelsus Medical University (PMU) Salzburg, AU
33 Harlachinger Str. 51
34 D-81547 Munich, Germany
35 Tel. +49 89 6211-0; Fax: +49 89 6211-2012
36 E-Mail: CWuertinger@Schoen-Kliniken.de; CSiepe@Schoen-Kliniken.de

1
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 Long-Term Clinical and Radiographic Analysis following TDR

1 Abstract

2 Background Context: Total lumbar disc replacement (TDR) intends to avoid fusion related negative side effects

3 by means of motion preservation. Despite of their widespread use, the adequate quality and quantity of motion as

4 well as the correlation between radiographic data with the patient´s clinical symptomatology remains to be

5 established. Long-term data are lacking in particular.

6 Purpose: To perform a clinical and radiographic long-term investigation following TDR with special emphasis on

7 motion preservation assessment and to establish any potential correlation with patient reported outcome

8 parameters.

9 Study Design/Setting: Prospective, single-center, clinical and radiological investigation following TDR with

10 ProDisc II (Synthes, Paoli, PA, USA).

11 Patient Sample: Patients with a minimum 5-year FU after TDR performed for the treatment of intractable and

12 predominant ( ≥ 80%) axial LBP resulting from single-level DDD without instabilities or deformities at the

13 lumbosacral junction (L5/S1).

14 Outcome Measures: Visual analogue scale (VAS), Oswestry Disability Index (ODI) and patient satisfaction

15 rates (three-scale outcome rating); range of motion (ROM) at the index- and cranially adjacent level as well as

16 segmental and global lumbar lordosis.

17 Methods: All data were acquired within the framework of an ongoing prospective clinical trial. Patients were

18 examined preoperatively, 3, 6, and 12 months postoperatively, annually thereafter. X-rays were performed in ap-

19 and lateral views as well as functional flexion / extension images. Radiological examinations included range of

20 motion (ROM) at the index- and cranially adjacent level as well as segmental and global lumbar lordosis. X-Ray

21 measurements were correlated with the clinical outcome parameters. A longitudinal analysis was performed

22 between baseline data with those from the early (3-6 months), mid- (12-24 months) and late FU stages (≥ 5

23 years).

2
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 Long-Term Clinical and Radiographic Analysis following TDR

1 Results: Results from 51 patients with a mean FU of 7.8 years (range 5.0-13.3 years) were available for the

2 final analysis. X-ray measurements revealed a maintained mobility with a trend towards gradually declining ROM

3 values. Whilst no statistically significant difference in ROM was detected between the preoperative and early FU

4 (6.8° vs. 5.8°, p=0.1), a further reduction in ROM became statistically significant at the mid- and final FU with

5 mean ROM of 5.2° and 4.4°, respectively (p <0.001).

6 Global lumbar lordosis increased from 48.8° to 54.4° (p<0.0001) which was attributed to a lordotic shift from

7 18.2° to 28.0° at the index segment (p<0.00001) and which was positively correlated with the applied implant

8 lordosis (p<0.05). A compensatory reduction of lordosis was observed at the cranially adjacent segment (p

9 <0.0001). The mobility of the cranially adjacent level remained unchanged (p>0.05).

10 The clinical outcome scores (VAS, ODI) revealed a significant improvement from baseline levels (p<0.05). The

11 reduction in ROM was not negatively correlated with the patient´s clinical symptomatology (p>0.05).

12 Conclusion: The present data reveal an increased global lumbar lordosis resulting from a lordotic shift of the

13 index segment, which was strongly correlated with the applied implant lordosis. This lordotic shift was

14 accompanied by a compensatory reduction of lordosis at the cranially adjacent segment.

15 A gradual and statistically significant decline of the device mobility was noted over time which, however, did not

16 negatively impact the patient´s clinical symptomatology.

17 Whilst the present long-term investigation provides additional insight into longitudinal radiographic changes and

18 their influence on the patient´s clinical symptomatology following TDR, the adequate quality and quantity of

19 motion with artificial motion preserving implants remains to be established which will aid in defining more refined

20 treatment concepts for both fusion and motion preserving techniques alike.

21 Keywords: lumbar disc replacement; disc arthroplasty; long-term results; motion

22 preservation; mobility; range of motion
23

3
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 Long-Term Clinical and Radiographic Analysis following TDR

1 Introduction

2 Fusion of lumbar motion segments currently represents the mainstay of treatment for patients suffering from

3 intractable low back pain (LBP) resulting from lumbar degenerative disc disease (DDD) which has been

4 unresponsive to conservative treatment. However, a variety of negative side effects have been reported such as

5 access-related collateral muscle damage, sagittal imbalance, graft site morbidity, screw loosening,

6 pseudarthrosis, adjacent level facet joint violations, high rates of adjacent level pathologies as well as

7 considerable complication and reoperation rates.[1-17] Adjacent level pathologies in particular have been linked

8 to the fusion of lumbar motion segments, with an excessive shift of applied loads being transmitted to the

9 neighboring segments.

10 In an attempt to avoid these above mentioned negative side effects, motion preserving techniques such as total

11 lumbar disc replacement (TDR) have been introduced. The ultimate rationale behind TDR is to preserve mobility

12 over an extended period of time and hence to avoid or reduce the incidence of adjacent level pathologies.

13 Since their introduction in the early 1980´s, a paucity of information still persists with regard to the quality and

14 quantity of motion of these kind of devices. Radiographic long-term data are lacking in particular, including

15 information on whether TDR lives up to its expectations to maintain motion over a reasonable amount of time.

16 Likewise, the correlation between the device mobility and the patient reported outcome parameters remains to be

17 established.

18 Consequently, the aim of this prospective investigation was to perform a clinical and radiographic investigation

19 with long-term data following TDR with ProDisc II (DePuy Synthes, West Chester, PA, USA) with special

20 emphasis on motion preservation and, ultimately, to establish whether there was any correlation with the patient´s

21 clinical outcome.

4
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 Long-Term Clinical and Radiographic Analysis following TDR

1 Materials and Methods

2 Preoperative diagnosis and patient selection

3 All patients included in this study are part of an ongoing prospective clinical trial with ProDisc II (DePuy Synthes,

4 West Chester, PA, USA). The minimum FU required for inclusion in this study was 5 years.

5 Disc replacement was performed for the treatment of patients with predominant (> 80%) axial low back pain

6 (LBP) originating from lumbar DDD. All patients were non-responders to an intensive conservative inpatient

7 and/or outpatient treatment program conducted over a minimum period of 6 months.

8 Indications and contraindications for this procedure have thoroughly been outlined previously (Tab. 1).[18-24]

9 Radiculopathy was considered a clear contraindication against TDR. Patients with a history of previous revision

10 surgery as well as patients with combined fusion and TDR procedures were excluded from this study.

11 In order to define a homogeneous study cohort, only patients with TDR performed at the lumbosacral junction,

12 defined as L5/S1, were included in this present investigation whilst patients with transitional anomalies or with

13 TDRs above the level of the lumbosacral junction were excluded.

14 The preoperative diagnosis was made on the basis of standard full standing X-rays taken in antero-posterior (ap)

15 and lateral views, functional flexion and extension images and preoperative magnetic resonance imaging (MRI) of

16 the lumbar spine.

17 Patients with previous discectomies were excluded in cases where Gadolinium-DTPA MRI revealed any notable

18 scar tissue formation in the spinal canal.

19 Preoperatively, all patients underwent fluoroscopically guided spine infiltrations to rule out non-discogenic pain

20 sources. Patients who demonstrated a significant and reproducible pain relief (> 50%) following infiltrations of the

21 facet joints or the sacroiliac joints were not considered candidates for TDR as a discogenic origin of pain was less

22 likely and nonsurgical treatment was the preferred treatment option.

23 The role of discography in identifying discogenic pain remains controversially debated. Previous studies revealed

24 an equally high rate of false-positive and false-negative results, failure to distinguish between concordant an non-

25 concordant pain, 100% memory pain in patients with abnormal psychometric testing and 0.5% infection rate.[25-

26 27] A number of studies revealed that the cascade of disc degeneration may be initiated with a mere needle

27 puncture, i.e. that used in lumbar discography.[28-37] A recent study furthermore demonstrated pressure

5
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 Long-Term Clinical and Radiographic Analysis following TDR

1 increases in adjacent level discs during lumbar discography, which led the authors to question the method´s

2 validity.[38-40] Consequently, discography was not used as a diagnostic tool in the present study.

3 Women older than 45 and men over the age of 55 years received routine DXA-scans (dual radiograph

4 absorptiometry) for bone density measurements. In accordance with the World Health Organization (WHO)

5 definition of osteopenia, patients with a T-Score exceeding -1,0 were not considered candidates for TDR.

6 Disc spaces were approached through a mini-open laparotomy and a left retroperitoneal approach as described

7 elsewhere.[41, 42] Insertion of the ProDisc implant was performed according to the manufacturer´s

8 guidelines.[43]

9 Clinical data acquisition

10 Study documentation was standardized and included the visual analog scale (VAS) as well as Oswestry disability

11 index (ODI).[44] The patient’s subjective outcome evaluation was based on a 3-scale grading system, namely

12 ‘highly satisfied’, ‘satisfied’ and ‘not satisfied.’ In addition, the patients were asked if, retrospectively, they would

13 be willing to opt for surgery again.

14 The clinical data acquisition was performed by members of the clinic’s spine unit including medical staff, research

15 assistants and research nurses. Medical staff who were involved in the data acquisition were members of the

16 spine unit who were not involved in the process of pre- or postoperative decision-making.

17 In order to perform a longitudinal analysis between varying outcome stages, clinical and radiographic data were

18 categorized into 4 groups: results obtained from preop. data (Preop), early FU (FUEARLY, 3-6 months), mid-term

19 FU (FUMID, 12-24 months) as well as data from each patients final FU examination at ≥5 years (FULATE ),

20 respectively.

21 Radiological evaluation

22 Radiographic images included standard full standing ap- and lateral views as well as functional flexion /

23 extension images. The X-Ray images were digitized and transferred to a computer station for further analysis.

24 All measurements were performed by two experienced and independent observers who were blinded to the

25 clinical results using a medical image analysis software (Surgimaps, Nemaris Inc., New York, USA). The means

26 from both observers were incorporated into the final statistical analysis.

6
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 Long-Term Clinical and Radiographic Analysis following TDR

1 Radiological measurements included the sagittal plane rotation (ROM) at the index and at the cranially adjacent

2 segment. ROM was established as the difference between maximum flexion and extension image

3 measurements. Standard Cobb measurements were used to determine the preoperative ROM, segmental and

4 global lumbar lordosis (L1-S1) as described and recommended previously.[45]

5 For postoperative ROM measurements, an improved precision and inter-/ intraobserver reliability has been

6 reported when the spikes of the upper and lower prosthesis keels were used as radiologic landmarks.[46-48] This

7 method was therefore used to determine the postoperative segmental ROM.

8 Statistical Analysis

9 All data were statistically evaluated by an external, independent statistician who was not involved in the process

10 of pre- or postoperative decision making. Data consistency was checked and data were screened for outliers and

11 normality by using quantile plots. Repeated measures ANOVA with time as factor was used to compare means

12 over time. LSD-tests as post-hoc tests with 95% confidence intervals for the effects were performed. Spearman’s

13 correlation coefficient together with tests were computed to evaluate correlations. All reported tests were two-

14 sided, and p-values <0.05 were considered as statistically significant. The statistical analyses were performed

15 with STATISTICA 10. [49, 50]

7
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 Long-Term Clinical and Radiographic Analysis following TDR

1 Results

2 Study population and cohort definition

3 The results from 51 patients with a mean FU of 7.8 years (range 5.0-13.3 years) were included in the final

4 analysis. N=18 patients were male (35.3%), n=33 (64.7 %) were female with an average age of 45 years (range

5 29 - 66 years).

6 Clinical Results

7 The clinical outcome parameters revealed a significant and maintained improvement in comparison to baseline

8 levels. VAS scores improved from 6.8 (SD +/- 1.6) preoperatively to 1.7 (SD +/- 2.8) at the final FU (p<0.00001).

9 Likewise, ODI scores demonstrated a highly significant reduction from 40.2 (SD +/- 15.1) to 19.0 (SD +/- 18.0) at

10 the FULATE, respectively (p<0.00001).

11 N=36 patients (71%) reported a highly satisfactory or a satisfactory outcome (n=9 patients; 18%), whilst n=5

12 patients (10%) reported unsatisfactory results with persisting complaints. In n=1 patient (2%), the subjective

13 outcome evaluation was not available.

14

15 Range of Motion (ROM) - Index Segment

16 Pre- and postoperative ROM values (means and 95% CI) are delineated in Fig. 1. The mean range of motion at

17 the index level was 6.8° (SD +/- 4.4°) preoperatively and slightly decreased to 5.8° at the early FU (p > 0.05).

18 A further decline to 5.2° (SD +/-3.3°, p<0.012) and 4.4° (SD +/- 3.5°, p<0.00015) became statistically significant

19 at the FUMID and FULATE , respectively.

20 In accordance with previously defined FDA criteria of mobility assessment, the implants´ ROM was further

21 subdivided and categorized into devices which demonstrated a mobility of greater or less than 5° of motion (Tab.

22 2). Prior to surgery, n=30 TDRs (58.8%) had a ROM of > 5°, whilst n=21 (41.2%) demonstrated a ROM of <5°.

23 At the late FU, these distributions changed to only 37.7% (n=19/51) of implants exceeding a ROM of 5°, whilst

24 the number of TDRs which revealed a ROM of <5° increased to 62.7% (n=32/51).

8
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 Long-Term Clinical and Radiographic Analysis following TDR

1 Range of Motion (ROM) - cranially adjacent segment

2 The mean ROM obtained from measurements at the cranially adjacent motion segment (L4/5) was 9.0°

3 preoperatively (SD +/- 5.1°), which increased slightly to 10.0° (SD +/- 4.1°) at the early FU (p>0.5). The

4 measurements at FUMID and FULATE revealed a mean ROM of 8.5° (SD +/- 4.3°) and 7.9° (SD+/- 4.2°), which

5 similarly was not a significant change when compared to baseline values (p>0.05).

6 Segmental and Global Lumbar Lordosis

7 Segmental lumbar lordosis (SLL) at the index level, the cranially adjacent level as well as global lumbar lordosis

8 (GLL) are displayed in Fig. 2-4, respectively.

9 Global lumbar lordosis significantly increased from 48.8° to 54.4° (p < 0.0001; Fig. 2). This increase was

10 attributed to a highly significant shift into a lordotic position at the index segment from 18.2° (FUPRE)) to 28.0°

11 (FULATE ), respectively p<0.00001; Fig. 3).

12 This increase in index segment lordosis was accompanied by a discrete but statistically significant compensatory

13 reduction of lordosis at the cranially adjacent segment from 19.8° (SD +/- 4.5°) to 17.8° (FULATE, SD +/- 5.0°;

14 p<0.0000003; Fig. 4). No significant differences were noted between varying postoperative FU stages (p>0.05).

15 Implant induced Segmental Lumbar Lordosis

16 At the time the surgeries were performed, the device was available with 6° and 11° degrees of implant lordosis.

17 Additional lordosis options were introduced at later stages. As outlined in Fig. 5, a significant increase of

18 segmental lumbar lordosis was observed with both implant geometries likewise (p<0.05). The extent of the

19 lordotic shift was, however, directly and positively correlated with the applied implant lordosis and revealed a

20 significantly more pronounced shift into a lordotic position for the 11° implants in comparison to devices with 6° of

21 lordosis, respectively (p<0.05).

9
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 Long-Term Clinical and Radiographic Analysis following TDR

1 Influence of Segmental Lumbar Lordosis on ROM

2 Previous studies revealed that a significant increase in segmental lumbar lordosis may result in a subluxation of

3 the facet joints following TDR.[51-53] It was therefore investigated whether an increased segmental lumbar

4 lordosis (SLL), which was particularly observed for the 11° implants, was associated with decreased ROM

5 values. However, the present data do not reveal any relevant correlation between SLL and ROM at the index

6 segment at the various postoperative FU stages (p>0.05).

7 Correlation between Clinical Outcome Parameters and Range of Motion

8 With the exception of VAS scores at the late FU (p=0.022), there was no significant correlation between the index

9 segment´s mobility and the patient reported outcome parameters (p>0.05). For all other outcome parameters and

10 FU stages, the above described continuously declining ROM values at the index segment did not reveal any

11 negative impact on the patient´s clinical outcome.

10
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 Long-Term Clinical and Radiographic Analysis following TDR

1 Discussion

2 Fusion of lumbar motion segments has been linked with a variety of negative side effects such as access related

3 collateral muscle damage, sagittal imbalance, graft site morbidity, screw loosening, pseudarthrosis, adjacent level

4 facet joint violations, high rates of adjacent level pathologies as well as considerable complication and

5 reoperation rates.[1-17] Total lumbar disc replacement (TDR) devices have been introduced in the early 1980´s in

6 an attempt to avoid or reduce the incidence of the above mentioned negative side effects. Despite of their early

7 introduction, however, a paucity of information still persists with regard to their motion characteristics and whether

8 they can, in fact, preserve mobility over an extended period of time. Long-term data are lacking in particular

9 Motion Preservation

10 Establishing the physiological motion of the spine is an area of ongoing research, both for the whole spine as well

11 as for a functional spinal unit on a segmental level. An analysis of the current state of literature reveals a lack of

12 knowledge on the adequate quality and quantity of motion for both normal, physiological spinal movements as

13 well as for artificial motion preserving devices.[54, 55] A segmental mobility of 5° has previously been defined as

14 a threshold value and success criteria in U.S. FDA IDE prospective randomized controlled trials for insufficient

15 motion or even fusion.

16 The data from this present investigation provide further insight into the long-term mobility of TDR implants after a

17 mean FU of 7.8 years, ranging from 5.0-13.3 years. As outlined in Fig. 1, a gradual decline of the implant´s

18 mobility was observed over the postoperative course, which became statistically significant at the mid- and late

19 FU stages (p<0.05). This decline was furthermore reflected in an increasing proportion of patients with ROM

20 values below 5° (Tab. 2).

21 Previously published cross-sectional studies have reported on the spinal mobility in the general population,

22 including age and gender differences.[56-58]. In this context, Trudelle-Jackson et al. provided normative values

23 of the lumbar spine´s ROM.[58] The authors found significant age, gender and ethnical differences, with a

24 significant decrease of the lumbar spine´s mobility over time.

25 Taking the above mentioned data into consideration, the declining ROM values may partly be attributed to a

26 physiological aging process, which can similarly be found in an age matched normative population. At this stage,

11
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 Long-Term Clinical and Radiographic Analysis following TDR

1 however, it remains unclear whether the decline in the index segment´s mobility may solely be attributed to a

2 physiological aging process or whether it exceeds that of a normative and age adjusted population.

3 Correlation between Mobility and Clinical Results

4 A considerable number of studies have reported on the clinical efficacy of TDR, including class I data from

5 prospective randomized controlled trials.[18, 24, 59-64] Likewise, the present data similarly revealed a significant

6 improvement of all patient reported outcome parameters after a mean FU of 7.8 years, which was reflected in a

7 high proportion of patients who were satisfied or entirely satisfied with their subjective outcome and who reported

8 that, retrospectively, they would opt for surgery again.

9 The satisfactory results were maintained over the entire postoperative follow-up period. The patient´s clinical

10 symptomatology was therefore unaffected by the declining ROM values, which were observed at the same time.

11 A further in-depth analysis did not detect any statistically significant correlation between the device mobility and

12 the recorded clinical outcome parameters at any one of the pre- or postoperative FU stages (p>0.05).

13 Segmental and Global Lumbar Lordosis:

14 A segmental hyperlordosis as well as biomechanical alterations following TDR have previously been linked with

15 symptomatic facet joint complaints and significantly increased facet pressures.[52, 65-68] Previous studies

16 furthermore reported that an increased lordotic shift may ultimately result in a subluxation of the facet joints.[51-

17 53] MRI studies revealed an accelerated facet joint cartilage degeneration in less mobile segments following

18 TDR, which were referred to as ´locked in facet joints´.[69] An analysis of the segmental and global lumbar

19 lordosis was therefore an integral part of the present investigation, although whole standing spine radiographs

20 were not available at the time of the initiation of this study, which would have allowed to include an additional

21 analysis of pelvic parameters.

22 The present data reveal that TDR led to a highly significant increase of segmental lordosis at the index segment

23 (p<0.00001; Fig. 3), which furthermore resulted in an increased overall lumbar lordosis (L1-S1) from 48.8°-54.4°,

24 respectively (p<0.0001; Fig. 2). The amount of segmental lordosis was positively correlated with the applied

25 implant lordosis as outlined in Figure 5.

12
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 Long-Term Clinical and Radiographic Analysis following TDR

1 It should be taken into consideration that the data from this present long-term investigation include the results

2 from surgeries that were performed from the year 2000 onwards when significant and relevant information on

3 TDR was still lacking in comparison to today’s knowledge and expertise. At the time of the introduction of this

4 new surgical technique, there was a misperception with regard to lordosis reconstruction, which was based on

5 the idea that ´more lordosis in the lumbar spine is generally positive´ and which led to a more frequent use of

6 implants with higher (11° degree) lordosis angles.

7 However, the present data reveal that the index segment´s lordotic shift was accompanied by a compensatory

8 reduction of lordosis at the adjacent segment (Fig. 4), an observation which was similarly made early on in the

9 author´s institution. This observation combined with the above mentioned additional drawbacks of segmental

10 hyperlordosis ultimately led to the use of implants with less pronounced lordosis angles over time. Consequently,

11 11° implants were gradually abandoned and were replaced by 6°, 3° or even 0° implants which were introduced

12 at later stages. Options of lordosis shift to the caudal endplate were similarly introduced later on, which intends to

13 provide a more homogenous lordosis distribution between the cranial and caudal endplates. Whether these

14 advancements and changes made to the available implant geometries will ultimately reveal a beneficial effect on

15 the clinical results still remains to be established in upcoming studies.

16 Lordosis Reconstruction versus Clinical Results

17 Previous studies have reported on the importance of an adequate reconstruction of the segmental and sagittal

18 alignment in any reconstructive spine surgery.[70] In a physiological setting, the lumbosacral junction will

19 therefore constantly adjust its alignment during daily living activities. Any fixation of this biomechanically delicate

20 transitional area will ultimately eliminate any compensational segmental motion at the index segment, which may

21 be one of the main underlying reasons for postoperative complaints in lumbar fusion candidates.[5, 7, 12, 71, 72]

22 Previous studies have reported on the results of anterior stand alone fusion devices at the lumbosacral

23 junction.[73-77] Despite of the fact that all commonly perceived prerequisites for a satisfactory outcome were

24 achieved, i.e. noteworthy lordosis reconstruction, high fusion rates, avoidance of posterior muscle trauma,

25 avoidance of pedicle screws and posterior cranial facet joint violations etc., a considerable number of patients still

26 reported persisting complaints. During these types of surgeries, the surgeon will insert the implant in a way which

27 matches one particular intraoperative segmental alignment. Solid fusion, however, will undermine any kind of

13
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 Long-Term Clinical and Radiographic Analysis following TDR

1 compensational motion of the lumbosacral junction whilst performing activities of daily living (ADL) as outlined

2 above.

3 Conversely, TDR may permit a postoperative shift of the segment into a „point of equilibrium“, around which

4 some motion may suffice in order to adjust during ADL. This may explain the positive clinical results which have

5 been observed in this present investigation as well as in a large series of previous publications on TDR as

6 outlined above, which included early return to daily living and sporting activities as well as increased rates of

7 patients resuming their professional life.

8 However, the present data reveal that these type of simplified concepts such as ´greater segmental lordosis or

9 greater mobility are advantageous´ are overhauled, do not pay tribute to the complex biomechanics that are

10 encountered with the reconstruction of spinal segments and will therefore require careful reconsideration.

11 Thus, increasing knowledge gained from upcoming biomechanical, clinical and radiological studies will aid in

12 defining more refined treatment concepts for both fusion and motion preserving techniques alike.

13

14
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 Long-Term Clinical and Radiographic Analysis following TDR

1 Conclusion

2 The present data reveal an increased global lumbar lordosis, predominantly located at the index segment, which

3 was strongly correlated with the applied implant lordosis. The lordotic shift was accompanied by a compensatory

4 reduction of lordosis at the cranially adjacent segment.

5 The radiographic measurements revealed a gradual decline of the implant´s ROM over time, which did not

6 negatively impact the patient´s clinical symptomatology.

7 The results of the study point to the fact that previous perceptions on lordosis reconstruction or ROM following

8 TDR, where higher values were interpreted as ´positive and beneficial´, are overhauled and need to be redefined.

9 Whilst the present long-term investigation provides additional insight into longitudinal radiographic changes and

10 their influence on the patient´s clinical symptomatology following TDR, future studies are warranted which should

11 further investigate the quality and quantity of motion with artificial motion preserving devices.

15
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 Long-Term Clinical and Radiographic Analysis following TDR

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22 radiological parameters and pain. Eur Spine J. 2000;9(1):47-55.

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1 63. McAfee PC, Cunningham B, Holsapple G, et al. A prospective, randomized, multicenter Food and Drug

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 Long-Term Clinical and Radiographic Analysis following TDR

1 73. Behrbalk E, Uri O, Parks RM, Musson R, Soh RC, Boszczyk BM. Fusion and subsidence rate of stand

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8 in Lumbar Fusion: Mid-term Clinical Outcome and Radiological Fusion. J Spinal Disord Tech. 2012.

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12 Lumbar Interbody Single-level Fusion After a Mean Follow-up of 41 Months. J Spinal Disord Tech.

13 2012;25(7):362-9.

14

15

23
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 Long-Term Clinical and Radiographic Analysis following TDR

1 Figure 1: Range of motion (ROM) at the index segment

2 following total lumbar disc replacement at the level L5/S1

3
4
5 Figure 2: Global lumbar lordosis (GLL) following total lumbar
6 disc replacement at L5/S1

24
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 Long-Term Clinical and Radiographic Analysis following TDR

1
2
3 Figure 3: Segmental lumbar lordosis at the index segment
4 L5/S1

25
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 Long-Term Clinical and Radiographic Analysis following TDR

1
2
3 Figure 4: Segmental lumbar lordosis (SLL) at the cranially
4 adjacent level (L4/5) reveals a statistically significant reduction
5 in lordosis postoperatively (p<0.05).

26
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 Long-Term Clinical and Radiographic Analysis following TDR

1
2
3 Figure 5: Interdependence between applied implant lordosis
4 (6° vs 11° devices) and segmental lumbar lordosis (SLL) at
5 the index segment.

27
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 Long-Term Clinical and Radiographic Analysis following TDR

1
2

28
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 Long-Term Clinical and Radiographic Analysis following TDR

1 Tables

3 Table 1: Exclusion criteria / contraindications against total lumbar disc replacement (TDR)

4  Central or lateral spinal stenosis

5  Predominant radiculopathy

6  Facet joint arthrosis/symptomatic facet joint complaints

7  Spondylolysis/Spondylolysthesis

8  Spinal instability (iatrogenic/altered posterior elements; e.g. following laminectomy

9  Major deformity/curvature deviations (e.g. scoliosis)

10  Metabolic bone disease (e.g. manifest osteoporosis/ostepenia)

11  Previous operation with severe scar tissue and radiculopathy

12  Compromised vertebral body (irregular end plate shape)

13  Previous/latent infection

14  Metal allergy

15  Spinal tumor

16
17
18
19 Table 2: Distribution of segmental mobility at the index segment following total lumbar disc replacement (TDR) at
20 the lumbosacral junction. The results demonstrate a statistically significant decline towards lower ROM values
21 with a higher rate of patients with ROM<5° of motion (p<0.05).
22
Range of motion FU early FU mid FU late
(ROM) preop. (3-6 months) (12-24 months) (> 5 years)

> 5° 58.8% 54.9% 51.0% 37.3%

(n=30/51) (n=28/51) (n=26/51) (n=19/51)

< 5° 41.2% 45.1% 49.0% 62.7%

(n=21/51) (n=23/51) (n=25/51) (n=32/51)

23
24
25

29
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