Glenn R. Buttermann, MD

Lumbar Spinal Disc Replacement in a Community Practice Setting:

Early Results

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Intro: Lumbar TDR• Comparative studies for a lumbar TDR in a

community setting outside of an IDE setting are few.

• Purpose: compare a lumbar TDR for one level conditions, as well as “off-label” combination of disc replacement and spinal fusion as a “hybrid” construct for multilevel conditions, to fusion in a community spine practice.

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Methods• TDR (n=26) and single-level fusion (n=62) cohorts• TDR hybrids (n= 21) and 2-level A/P fusion (n=50) cohorts• Prospective outcomes• Hospitalization (LOS, EBL, implant costs)• Revisions, 2ndary operations

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Lumbar TDR vs ASF/PSF

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LUMBAR

Age (mean +/- SD) 38.2 ± 10.5 40.1 ± 11.4

Female (%) 58 77Smokers (%) 53 42Work Comp/Lit (%) 37 31EBL (ml, mean +/- SD) 89 ± 68 261 ± 214Secondary Surgery (%) 4 10+%/yr*

LUMBARAge (mean +/- SD) 45.5 ± 10.8 45.0 ± 11.6Female (%) 25 68Smokers (%) 42 50Work Comp/Lit (%) 67 48EBL (ml, mean +/- SD) 246 ± 301 499 ± 296Secondary Surgery (%) 6 10+%/yr**Majority were inst. Removal

Single Level TDR (n=26) Single Level ASF/PSF (n=62)

Hybrid TDR (n=21) Multi-Level ASF/PSF (n=50)

Low Back Pain Outcomes

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PRE-OP 7-12 MONTH

1-2 YEARS 2-4 YEARS0

2

4

6

8

10

ASF/PSF BACK PAIN

Single Level

2-level

FOLLOW-UP PERIOD

VA

S

0

2

4

6

8

10

PRE-OP 7-12 MONTH 1-2 YEARS 2-4 YEARS

VA

S

FOLLOW-UP PERIOD

TDR BACK PAIN

Single Level

Multi-level

Leg Pain Outcomes

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PRE-OP 7-12 MONTH 1-2 YEARS 2-4 YEARS0

2

4

6

8

10

ASF/PSFLEG PAIN

Single Level

2-level

FOLLOW-UP PERIOD

VA

S

0

2

4

6

8

10

PRE-OP 7-12 MONTH 1-2 YEARS 2-4 YEARS

VA

S

FOLLOW-UP PERIOD

TDR LEG PAIN

Single Level

Multi-level

Pain Drawing Outcomes

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PRE-OP 7-12 MONTH 1-2 YEARS 2-4 YEARS02468

101214161820

ASF/PSF PAIN DRAWING

Single Level

2-level

FOLLOW-UP PERIOD

PA

IN

AR

EA

PRE-OP 7-12 MONTH 1-2 YEARS 2-4 YEARS02468

101214161820

TDR PAIN DRAWING

Single Level

Multi-level

FOLLOW-UP PERIOD

PA

IN

AR

EA

Disability Outcomes

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PRE-OP 7-12 MONTH 1-2 YEARS 2-4 YEARS0

10

20

30

40

50

60

70

80

ASF/PSF OSWESTRY DISABILITY

Single Level

2-level

FOLLOW-UP PERIOD

Deg

ree

of

Dis

abil

ity

0

10

20

30

40

50

60

70

80

PRE-OP 7-12 MONTH 1-2 YEARS 2-4 YEARS

Deg

ree

of

Dis

abili

ty

FOLLOW-UP PERIOD

TDR OSWESTRY DISABILITY

Single Level

Multi-level

Results• Both TDR and spinal fusion groups had significantly

improved outcomes at all follow-up periods for both single and multilevel cases.

• There was no significant difference in outcomes between single level and multilevel cases within both the fusion and TDR groups.

• Single level cases, the TDR group had significantly greater ODI improvement relative to the fusion group at all follow-up periods.

• Single level TDR had trend for greater VAS improvement at 1-2yr and 2-4 yr follow-up periods.

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Results• For multi-level cases, the improvement was similar for

the hybrid and fusion group at all follow-up periods. • Implant costs were less for single level total disc

replacement compared to spinal fusion but equivalent or greater for hybrid constructs compared to multilevel fusion constructs.

• Range of motion was maintained in the total disc replacement groups.

• Secondary surgeries were greater for the fusion groups (instrumentation removal and adjacent segment conditions).

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Discussion

• Outcomes of current 1-level study similar to IDE studies.

• Current TDR (& hybrid reconstructions) outcomes equivalent to or better than fusion for properly selected patients.

• Lower short-term reoperation rates for TDR group.

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