Pro disc l replacement vs circumferential arthrodesis of spine

1. Prospective, Randomized, Multicenter Food and Drug
Administration Investigational Device Exemption Study of the
ProDisc -L Total Disc Replacement Compared with
Circumferential Arthrodesis for the Treatment of Two-Level
Lumbar Degenerative Disc Disease: Results at 24 months.
ProDisc -L
Total Disc Replacement
Circumferential
Arthrodesis
Level of Evidence: Therapeutic Level I

2. Performed by :
• Rick Delamarter, MD The Spine Institute at Saint John's Health Center,
1301 20th Street, Suite 400, Santa Monica, CA 90404
•
Jack E. Zigler, MD Texas Back Institute/Texas Health Research Institute,
6020 West Parker Road, Suite 200, Plano, TX 75093
•
Richard A. Balderston, MD Pennsylvania Hospital, 800 Spruce Street, 1st
Floor, 3B, Philadelphia, PA 19107
•
Frank P. Cammisa, MD Hospital for Special Surgery, 523 East 72nd Street,
New York, NY 10021
•
Jeffrey A. Goldstein, MD and Jeffrey M. Spivak, MD Hospital for Joint
Diseases Spine Center, 301 East 17th Street, New York, NY 10038

3. Presented in :
• The Journal of Bone & Joint Surgery. 2011; 93:705715 doi:10.2106/JBJS.I.00680

4. Degenerative Disc Disorder
-
Low Back Ache
A major public health problem
The leading cause of disability for people < 45
2nd leading cause for physician visits
3rd most common cause for surgical procedures
5th most common reason for hospitalizations
Lifetime prevalence: 49%–80%
Pai et al. 2004, Orthop Clin N Am

5. AIM
Arthrodesis / Spinal fusion had become a
standard surgical procedure , a more
predictable and reproducible.
symptomatic degenerative disease,
degenerative spondylolisthesis,
degenerative lumbar scoliosis, postdiscectomy-syndromes or segmental
instability adjacent to a previous fusion.
Arthrodesis alters the biomechanics of
the spine , loss of motion and overall
shift in the sagittal alingment
Induces degenerative changes in the
nearby spinal motion segments.

6. Total Disc Replacement
• Disc removal , assuming it to be the main source of pain
• Restoration of disc height (increase the foraminal diameter, relieve
loads across the facet joints and improve the pattern of load
bearing between vertebrae)
•
Segmental stability
• Preservation or improvement of segmental motion
• Lordosis curve (rebalance the spine - preserves the motion,
protect adjacent segment from accelerated degeneration.)
• Limit Disability & early return to work.
Total lumbar disc replacement, H. M. Mayer, MD, PhD, Orthopaedic Surgeon,
Neurosurgeon, Associate Professor, 2005, JBJS

7. TDA > Arthodesis
•
•
•
•
•
•
•
•
•
Guyer RD et al 2009 Delamarter R et al 2008 *
Cunningham BW et al 2008’
Siepe CJ et al 2007
Zigler J et al 2007 *
Panjabi et al 2007 *
Panjabi et al 2007’
Blumenthal S et al 2005*
Bertagnoli R et al 2005 *
•
The purpose of this study is to determine clinical results of
Pro Disc L Total Disc Replacement as compared with
Circumferential Spinal fusion for the treatment of degenerative
disease at two contagious vertebral levels from L3 to S1.

8. MATERIAL & METHOD
• From January 2002 to June 2004, a total of 256 patients were randomized
by 38 spine surgeons at 16 sites across the United States.
• Blocked randomization was performed in a controlled design
• with use of a 2:1 ratio of total disc arthroplasty to circumferential
arthrodesis
• Overall, 237 patients (165 in the total disc replacement group & 72 in the
arthrodesis group) were treated.
• At the end of the study of 24 months a total of 203 patients (including
143 in the total disc replacement group and 60 in the arthrodesis group
were available.

9. FLOW CHART of STUDY PATTERN

10. STUDY DESIGN
Inclusion criteria
• With degenrative disc disease at
two levels from L3 to S1.
• Patients who had minimum of 6
months of unsuccessful
nonoperative treatment
• +/- Leg pain
• With a minimum Oswestry
Disability Index ODI score of
>_ 40
Exclusion criteria
• spondylolisthesis >grade I,
• degenerative disc disease at
more than two levels,
• previous arthrodesis
• inability to comply with the
study protocol.

11. Degenerative Disc Disease includes
• Lumbar spine instability,
• loss of intervertebral disc height,
• scarring of the annulus fibrosus,
• herniated nucleus pulposus,
• vaccum phenomenon of disc
INVESTIGATION MODES :
•
•
•
•
•
Flexion-extension Radiographs,
Computed Tomography (CT),
Magnetic Resonance Imaging (MRI),
Discography,
Myelography

12. STUDY PATTERN
• Study approval was obtained from each site's institutional review board
prior to the start of the study. Patient randomization was performed with
use of a 2:1 ratio of TDR to circumferential arthrodesis.
• Patients in the investigational group were managed with TDR at both
levels.
• The control group was managed with a two-level anterior lumbar
interbody arthrodesis with use of a commercially available femoral ring
allograft and posterolateral arthrodesis with autogenous iliac crest bone
graft in combination with pedicle screw instrumentation.

13. STUDY GROUP
V/S
CONTROL GROUP

14. ProDisc-L Device Description
• a semi-constrained design
based on the ball-and-socket
principle
• consists of 2 End Plates
manufactured from cobaltchromium-molybdenum
(CoCrMo) alloy and a convex
ultra-high molecular weight
polyethylene (UHMWPE)
insert.
• Fixation is provided by a
central keel and titanium
plasma spray coating on each
end plate.
• Bone ingrowth

15. Pro Disc L

17. Pro Disc L
charite

18. Pro Disc L

19. Pro Disc L allowing movement during flexion and extension

20. SURGICAL METHOD
The surgical technique of
performing the two-level lumbar
arthroplasty is similar to that of a
single-level lumbar arthroplasty
• The entire disc is removed
from an anterior approach .
• The disc space is distracted.
• The TDR device is inserted.
Lumbar Total Disc Replacement, Surgical Techniques ,Patrick Tropiano, MD; Russel C.
Huang, MD; Federico P. Girardi, MD; Frank P. CammisaJr., MD; Thierry Marnay, MD
, March 01, 2006, JBJS (Am)

21. Lumbar Total Disc Replacement, Surgical Techniques ,Patrick Tropiano, MD; Russel C.
Huang, MD; Federico P. Girardi, MD; Frank P. CammisaJr., MD; Thierry Marnay, MD
, March 01, 2006, JBJS (Am)

22. Lumbar Total Disc Replacement, Surgical Techniques ,Patrick Tropiano, MD; Russel C.
Huang, MD; Federico P. Girardi, MD; Frank P. CammisaJr., MD; Thierry Marnay, MD
, March 01, 2006, JBJS (Am)

23. PRE OPERATIVE DEMOGRAPHIC DATA
• *Continuous variables were analyzed with the Wilcoxon rank-sum test,
and categorical variables were analyzed with the Fisher exact test.
†The values are given as the mean and the standard deviation.
‡Data were unavailable for one patient in the total disc replacement
group.
§Patients may be included in more than one category.
#Previous conservative treatment other than medication.

24. Demographic characteristics
Total Disc
Replacement
(N = 165)
Arthrodesis
(N= 72)
Sex No. of patients
P Value *
0.6701
Male
95
39
Female
70
33
Age (yrs)
41.8+_ 7.73
41.8 +- 7.81
0.9745
Body mass Index (kg/m2)
27+-4.52
27.1+_4.05
0.8723
Smoking status
0.1373
Never
86
29
Former
31
21
Current
47
22

25. Demographic characteristics
Total Disc
Replacement
(N = 165)
Arthrodesis
(N= 72)
Previous surgical treatment
P Value *
0.8864
None
96
43
Any
69
29
Discectomy
32
13
Intradiscal electrothermic theraphy
17
7
Laminectomy
31
9
Laminotomy
4
2
other
12
8

26. Demographic characteristics
Total Disc Replacement
(N = 165)
Arthrodesis
(N= 72)
Previous conservative treatment
P Value*
0.9436
injection
127
52
Physical therapy
135
61
Corset/Brace
68
28
chiropractic
60
28
other
35
12
Duration of pain in the Back / leg
0.6145
< 6 months
1
0
6 months to 1 year
16
4
> 1 year
148
68

27. Statistical methods
• For the purpose of FDA evaluation, a composite, binary end
point consisting of ten criteria was estabilished for each
treatment group.
• At the end of 24 months , the pateint had to meet all the 10
criteria for to be labelled as a successive or statistical failure

28. Components of Composite End Point at 24 Months
1. >_ 15% improvement in ODI compared with baseline
2. Improvement in SF-36 PCS compared with baseline
3. Neurological status improved or maintained from baseline
4. No secondary surgical procedures to remove or modify the total disc
replacement implant or arthrodesis implant/site
Radiographic success
5. No subsidence >3 mm
6. No migration >3 mm
7. No radiolucency/loosening
8. No loss of disc height >3 mm
Motion status
9. Total disc replacement: range of motion improved or maintained
from baseline
10.Arthrodesis: no motion (<10° angulation, total for two levels
combined) on flexion and extension radiographs
*ODI = Oswestry Disability Index; SF-36 PCS = Short Form-36 physical component score.

29. Critical Analysis

30. Intraoperative data showed that the TDR group had
•significantly decreased operative times (p < 0.0001),
•estimated blood loss (p = 0.0013), and
•length of hospital stay (p < 0.0001)
Intraoperative Data
Total Disc
Replacement
(N = 165)
Arthrodesis
(N= 72)
Implant level
P Value*
1.0000
L3 – L5
14
8
L4- L5
151
64
Operative time in min
160.2 +_ 73.30
272.8+_ 81.68
< 0.0001
Estimated blood loss in ml
398.1+_451.48
569.3 +- 466.63
0.0013
Length of hospital stay in days
3.8+_ 1.53
5+_1.93
<0.0001
*Continuous variables were analyzed with the Wilcoxon rank-sum test, and categorical variables were analyzed with the Fisher
exact test.
†The values are given as the mean and the standard deviation.
‡Data were unavailable for three patients in the total disc replacement group.

31. Clinical Outcome Measurements
• patient was clinically evaluated preoperatively, at 6 weeks postoperatively,
and at 3,6,12,18,24 months postoperatively.
• Every visit included physical and neurological examinations, radiographic
evaluation, determination of medication use, work and recreation status,
and completion of self-assessment questionnaires (including the ODI,
Short Form of the Medical Outcomes Study [SF-36], and visual analog
scales [VAS] for pain and satisfaction.
• Physical and neurological examinations were performed to assess nerve
root tension, reflexes, muscle strength, and sensory deficits. Radiographic
evaluation consisted of neutral anteroposterior and lateral views, flexionextension views, and lateral bending views.

32. Clinical Outcomes: Primary
• At twenty-four months, eighty-seven (58.8%) of 148 patients
in the total disc replacement group and thirty-two (47.8%) of
sixty-seven patients in the arthrodesis group met all ten
criteria and were considered a study succes
• non-inferiority was demonstrated between the two groups
with use of a Blackwelder hypothesis with ? = 0.125 (p =
0.0008).
• The difference between the two treatments was not
significant (p = 0.0874).

33. Oswestry Disability Index (ODI)
• The ODI low back pain disability questionnaire is a validated method of
assessing a patient's level of pain and functional disability.
• Baseline preoperative ODI values were similar for both treatment groups
(64.7 points for the TDR group, compared with 64.8 points for the
arthrodesis group)
• In both groups, patients showed significant improvement in ODI scores
from baseline at all follow-up periods (p < 0.0001).
• The total disc replacement group demonstrated significantly greater
improvement than the arthrodesis group did at all follow-up time points
(p = 0.0474).
• At twenty-four months, the mean improvement from baseline
was 52.4% in the total disc replacement group compared with
40.9% in the arthrodesis group (p = 0.0282).

34. Oswestry Disability Index Scores
Oswestry Disability Index
Score*(points)
Percentage Change from
Baseline*(%)
Time Point
Total Disc
Replacement
Arthrodesis Total Disc
Replacement
Arthrodesis P Value*
Baseline
64.7 ± 11.4
64.8 ± 9.5
-
-
-
6 wks
43.8 ± 18.2
50.8 ± 17.8
30.8 ± 28.9
22.2 ± 27.2
0.0228
3 months
38.1 ± 20.7
44.4 ± 15.7
40.5 ± 32.3
30.9 ± 24.6
0.0445
6 months
35.1 ± 21.9
43.9 ± 17.1
45.3 ± 34.6
32.3 ± 26.7
0.0068
12 months
33.7 ± 23.9
41.1 ± 23.0
48.0 ± 36.4
37.9 ± 34.7
0.0474
18 months
32.8 ± 24.7
42.3 ± 22.5
49.3 ± 37.9
36.1 ± 33.8
0.0215
24 months
30.3 ± 24.3
38.7 ± 24.1
52.4 ± 38.1
40.9 ± 36.0
0.0282
*The values are given as the mean and the standard deviation.
†The Wilcoxon rank-sum test was used to compare total disc replacement and
arthrodesis with regard to the percentage change from baseline.

35. OSWESTRY DISABILITY INDEX - ODI
•
•
•
•
•
•
•
•
•
•
Pain intensity
Personal care
Lifting
Walking
Sitting
Standing
Sleeping
Sex life
Social life
Travelling
• 0 to 20 % Minimal
disability
• 21 to 40 % Moderate
disability
• 41 to 60 % Severe
disability
• 61 to 80% crippled
• 81 to 100 % Bed bound

36. SF-36 Physical Component Score
• Baseline preoperative values for the SF-36 physical component score (PCS)
were similar for both treatment groups (29.5 points for the total disc
replacement group, compared with 30.1 points for the arthrodesis group)
• Both treatment groups showed significant improvement at all follow-up
time-points in comparison with baseline (p < 0.0279).
• The total disc replacement group showed significant improvement
compared with the arthrodesis group at six weeks and at three, six, and
twenty-four months (p = 0.0379, p = 0.0044, p = 0.0068, and p = 0.0141,
respectively).
• At twenty-four months, the score for the total disc
replacement group improved to a mean of 43.9 points and
the score for the arthrodesis group improved to a mean of
39.2 points.

37. Short Form-36 Physical Component Scores
Short Form-36 Physical
Component Score*(points)
Percentage Change from
Baseline*(%)
Time Point
Total Disc
Arthrodesis
Replacement
Total Disc
Arthrodesis
Replacement
P Value†
Baseline
29.5 ± 5.4
30.1 ± 6.7
—
—
—
6 weeks
34.8 ± 7.7
31.9 ± 6.9
21.4 ± 33.4
12.2 ± 32.2
0.0379
3 months
38.7 ± 9.4
34.7 ± 7.3
34.9 ± 38.2
20.7 ± 37.7
0.0044
6 months
41.2 ± 10.3
37.0 ± 9.1
43.8 ± 45.6
30.1 ± 48.3
0.0068
12 months
42.4 ± 11.2
39.3 ± 9.9
48.8 ± 51.6
38.3 ± 47.0
0.1108
18 months
42.7 ± 11.5
38.1 ± 10.7
51.4 ± 55.6
37.7 ± 52.0
0.0899
24 months
43.9 ± 11.9
39.2 ± 11.2
54.2 ± 54.6
36.2 ± 44.9
0.0141
*The values are given as the mean and the standard deviation.
†The Wilcoxon rank-sum test was used to compare the total disc replacement and
arthrodesis groups with regard to the percentage change from baseline.

38. Neurological Success
• Neurological success was defined as the maintenance or improvement of
patient responses to all neurological criteria, including motor status,
sensory status, reflexes, and a straight leg raise test
• At six months, the percentage of patients with neurological success was
significantly higher in the TDR group (87.3%; 131 of 150) than in the
arthrodesis group (71.6%; forty-eight of sixty-seven) (p = 0.0068).
• At twenty-four months, the percentage remained higher in
the total disc replacement group (89.2%; 132 of 148) than in
the arthrodesis group (80.6%, fifty of sixty-two), but this small
difference was not significant.
• The Fisher exact test (two-sided) was used to compare the total disc
replacement and arthrodesis groups.

39. 6 weeks
Overall
neurological
success
Total disc
82.1%
replacement
24 months
3 Months
6 Months
12Months
18Months
80.9%
87.3%
86.2%
86.4%
89.2%
Arthrodesis
83.3%
81.2%
71.6%
76.2%
77.6%
80.6%
P value*
1.0000
1.0000
0.0068
0.1037
0.1730
0.1192
Total disc
94.9%
replacement
97.5%
96.0%
97.8%
98.6%
98.0%
Arthrodesis
95.5%
97.1%
97.0%
96.9%
98.0%
100.0%
P value*
1.0000
1.0000
1.0000
0.6514
1.0000
0.5567
Total disc
88.5%
replacement
88.5%
95.3%
94.2%
93.6%
93.9%
Arthrodesis
91.0%
88.4%
86.6%
85.9%
88.0%
91.9%
P value*
0.6446
1.0000
0.0446
0.0581
0.2277
0.5601
Motor status
Sensory

40. Secondary Surgical Procedures
• Overall, four (2.4%) of 165 patients in the total disc replacement group
and six (8.3%) of seventy-two patients in the arthrodesis group required a
secondary surgical procedure at the index level or levels.
• This fourfold difference in the rate of secondary surgery for the
arthrodesis group was significant (p = 0.0465).
• The average number of days from the index procedure to secondary
surgery was 567.7 (range, 480 to 736) in the total disc replacement group
and 255.5 (range, twenty-one to 560) in the arthrodesis group.

41. SECONDARY SURGICAL PROCEDURES
• One patient (0.6%) in the total disc replacement group had anterior
migration of the superior arthroplasty implant and underwent revision
arthrodesis at that level.
• The remaining 3 patients (1.8%) in the TDR group underwent a secondary
surgical procedure (foraminotomy and/or facetectomy) for posterior
decompression; 2 these patients underwent a one-level decompression,
and one patient underwent a decompression at both levels.
• Of the 6 patients who underwent a secondary surgical procedure in the
arthrodesis group, 5 had spinal implant removal because of ongoing pain
and one had implant removal, decompression (bilateral medial
facetectomy and hemilaminectomy), and revision of the bone fusion sites
because of a pseudarthrosis at L5-S1.

42. Radiographic Outcomes
• The radiographic outcomes that were assessed included
• device migration ( 1 anterior migration of the superior arthroplasty
implant)
• device subsidence(3 patients in TDR of > 3 mm-clinically insignificant),
• disc height,
• radiolucency around the implant,
• Fusion status in the arthrodesis group
• Flexion-Extension range of motion in the TDR group averaged
7.8° ± 5.3° at the level of the superior disc
6.2° ± 4.1° at the level of the inferior disc

43. Lateral views of Lumbar spineof a 38 yr old treated with ProDisc L Total Disc
Replacement at L3 -4 and L4-5 level made at end of 24 month followup .
X Rays are taken in Neutral , Flexion and in Extension of lumbar spine.

44. Clinical Outcomes: Secondary
Visual Analog Scale for Pain
• For both groups, the VAS pain assessment showed significant
improvement from preoperative levels at all time points postoperatively
(p < 0.0001)
• At twenty-four months, the mean VAS score demonstrated a 43.3-mm
mean reduction from baseline for the total disc replacement group
compared with a 36.7-mm mean reduction for the arthrodesis group.
• A significant difference between the treatment groups was observed only
at the eighteen-month follow-up (p = 0.0248).

45. Visual Analog Pain Scores
Visual Analog Pain Score*
Change from Baseline*
Time Point
Total Disc
Arthrodesis
Replacement
Total Disc
Arthrodesis
Replacement
P Value†
Baseline
75.7 ± 16.0
74.7 ± 13.6
—
—
—
6 weeks
41.5 ± 25.4
46.5 ± 24.9
34.5 ± 28.6
28.7 ± 28.4
0.1437
3 months
38.9 ± 27.6
42.1 ± 23.4
36.7 ± 28.5
32.3 ± 26.0
0.3170
6 months
37.9 ± 27.5
44.3 ± 26.0
38.1 ± 29.6
30.4 ± 28.6
0.0715
12 months
35.6 ± 28.5
40.3 ± 27.9
40.4 ± 29.4
34.9 ± 28.5
0.2527
18 months
35.2 ± 29.8
45.6 ± 30.3
40.3 ± 31.9
28.7 ± 31.0
0.0248
24 months
31.9 ± 30.5
38.4 ± 29.8
43.3 ± 33.3
36.7 ± 30.3
0.1177
*The values are given as the mean and the standard deviation.
†The Wilcoxon rank-sum test was used to compare the total disc replacement and
arthrodesis groups.

46. Visual Analog Scale for Patient Satisfaction and Willingness to Undergo
Surgery Again
• At twenty-four months, the mean score was 77.7 mm for the total disc
replacement group compared with 68.9 mm for the arthrodesis group
(p = 0.0126).
• Patients were asked whether they would have the same surgical
treatment again.
• At 6 weeks through eighteen months, patients responded "yes" at a
significantly higher rate in the total disc replacement group than in the
arthrodesis group (p < 0.0384).
• At 24 months, the percentage of patients who responded "yes" was
78.2% (111 of 142) in the total disc replacement group compared with
62.1% (thirty-six of fifty-eight) in the arthrodesis group (p = 0.0546).

47. Visual Analog Scores for Satisfaction
Time Point
Total Disc Replacement
Arthrodesis
P Value†
6 weeks
78.93 ± 21.80
72.44 ± 25.03 0.0731
3 months
78.17 ± 23.46
70.87 ± 25.39 0.0056
6 months
77.67 ± 23.02
67.81 ± 24.87 0.0015
12 months
76.53 ± 26.45
67.76 ± 31.01 0.0244
18 months
75.40 ± 28.06
65.49 ± 30.76 0.0375
24 months
77.70 ± 27.95
68.89 ± 30.50 0.0126
*The values are given as the mean and the standard deviation.
†The Wilcoxon rank-sum test was used to compare the total disc replacement and
arthrodesis groups.

48. Narcotic Use
• Preoperatively, 69.1% (114) of 165 patients in the total disc replacement
group and 63.9% (forty-six) of seventy-two patients in the arthrodesis
group reported using narcotics.
• At twenty-four months, there was a significant decrease, favoring the total
disc replacement group, in terms of the percentage of patients using
narcotics (p = 0.0020).

49. Line graph showing the percentage of patients using narcotics for each
surgical treatment over time. (TDR = Total Disc Replacement)

50. Work and Recreation Status
•
Preoperatively, there was no significant difference between the total disc
replacement group (79.4%; 131 of 165) and the arthrodesis group (83.3%;
sixty of seventy-two) in terms of the employment rate (p = 0.5928). Similarly,
at twenty-four months, there was no significant difference between the total
disc replacement group (80.4%; 115 of 143) and the arthrodesis group (86.0%;
forty-nine of fifty-seven) in terms of the employment rate (p = 0.4193).
•
Preoperatively, there was no significant difference between the total disc
replacement group (36.4%; sixty of 165) and the arthrodesis group (43.7%;
thirty-one of seventy-one) in terms of the percentage of patients participating
in recreational activities (p = 0.3099). The percentage of patients participating
in recreational activities had increased in both groups at twenty-four months,
with no significant difference between the total disc replacement group
(84.6%; 121 of 143) and the arthrodesis group (79.7%; forty-seven of fiftynine) (p = 0.4121).

51. Complications
• Major surgery-related complications included one dural tear in the total
disc replacement group (0.6%; 1/165) and 3 dural tears in the arthrodesis
group (4.2%; 3/72).
• Blood loss of >1500 mL occurred in 2/165 (1.2%) of patients in the TDR
group and 2/72(2.8%) of patients in the arthrodesis group.
• One of the two patients in the total disc replacement group sustained an
iliac artery tear
• One patient in the total disc replacement group and the 2 patients in the
arthrodesis group had excessive Oozing from the decompression,
decorticated bone, and graft sites.
• Postoperatively DVT was reported in 2/165 (1.2%) .of patients in the TDR
group and 2/72 (2.8%) of in the arthrodesis group

52. RESULTS
• At twenty-four months, 58.8% (87/ 148 )patients in the TDR group were
classified as a statistical success, compared with 47.8% (32/67)patients in
the arthrodesis group; non-inferiority was demonstrated.
• The mean Oswestry Disability Index in both groups significantly improved
from baseline (p < 0.0001); the mean percentage improvement for the
total disc replacement group was significantly better than that for the
arthrodesis group (p = 0.0282).
• An established clinical criterion for success, a =15-point improvement in
the Oswestry Disability Index from baseline, occurred in 73.2% (109/149 )
patients in the total disc replacement group and 59.7% (37/62)patients in
the arthrodesis group.

53. RESULTS
• The SF-36 physical component scores were significantly better for the total
disc replacement group as compared with the arthrodesis group (p =
0.0141 at twenty-four months).
• VAS scores for satisfaction significantly favored total disc replacement
from 3 to 24 months. At twenty-four months, 78.2% (111/142) patients in
the total disc replacement group and 62.1% (36/58) patients in the
arthrodesis group responded "yes" when asked if they would have the
same surgery again.
• Lumbar spine range of motion on radiographs averaged 7.8° at the
superior disc and 6.2° at the inferior disc in patients with total disc
replacement. Auerbach JD et al 2007, 2009.
• Reduction in narcotics usage significantly favored the total disc
replacement group at twenty-four months after surgery (p = 0.0020).

54. CONCLUSION
• Despite the relatively short duration of follow-up and design limitations,
the present study suggests that two-level lumbar disc arthroplasty is an
alternative to and offers clinical advantages in terms of pain relief and
functional recovery in comparison with arthrodesis.
• Longer-term follow-up is needed to determine the risks for implant wear
and/or degenerative segment changes.

55. SB Charité III
(Metal – poly - metal)
• SB Charite III
• Pro Disc L
• Maverick
(Metal on Metal)
• Flexicore
• Mobidisc

56. ProDisc L
Maverick disc

57. Ideal properties of an Implant
• Biocompatible (endure in vivo for up to 40 yrs)
• Biomechanical properties should allow for a nearnormal range of movement and function.
• The design should facilitate safe implantation,
preferably through a modest incision
• The implant must not preclude modern imaging
techniques for periodic monitoring and regard must
be given to the possible need for revision or salvage
procedures.
Total lumbar disc replacement, H. M. Mayer, MD, PhD, Orthopaedic Surgeon,
Neurosurgeon, Associate Professor, 2005, JBJS

58. HOME CARRYING MESSAGE
• Total Disc Replacement proves to an ideal choice of surgical
procedure for the treatment of DDD.
• The promise of Disc tissue regeneration via Gene therapy ,
Tissue engineering is on the horizon.

59. THANKS

60. …….. Known is a drop….
…………………..unknown is an
ocean………..
Dr. Kalaivanan Kanniyan
Senior Resident– Orthopaedics
UCMS, GTB Hospital, Delhi,India.