Least Invasive Lumbar Decompression, Interbody Fusion &

Pedicle Screw Implantation (LINDIF)

A Case Series Report

Disclosures

Royalties from Zimmer Spine

Least Invasive Lumbar Decompression, Interbody Fusion &

Pedicle Screw Implantation (LINDIF)

A Case Series Report

To our Japanese colleagues who are here and back home:

Kokoro yori okuyami moushiagemasu

(From the heart I give you my condolences)

Least Invasive Lumbar Decompression, Interbody Fusion &

Pedicle Screw Implantation (LINDIF)

A Case Series Report

Said G Osman, M.D.

List of Desirables

Desire to reduce:

* Surgical trauma

* Blood loss and the need for transfusion

* Anesthetic time

* Hospital stay

Post-op pain medicines

Down time to normal activities early

* Risk of complications in the elderly

* Escalating health care cost

* Desire by elderly patients to maintain high level of physical activities

To determine if LINDIF can realize those desirable outcomes

Patient Sample: Case series by one surgeon at two centers

Outcome Measures: Operating time; intra-operative blood loss;

hospital stay; VAS scores for back and leg pain; Roland-Morris

Disability Questionnaire; and post-operative imaging studies.

Materials and Methods

Total # of Patients = 60

Male = 30

Female = 30

Materials and Methods

Deg Disc Disease = 5

Deg. Motion Seg. = 49

Spondylolisthesis = 6

Operative Routine

Prophylactic Antibiotics

* Endotracheal Anesthesia

Foley catheterization

* Neuro-monitor

* DVT prophylaxis

Open frame operating table

* Prone position

* Transparent drapes

Fluoroscopy/Navigation system

Procedure

Percutaneous Pedicle Screw Instrumentation

Interbody fusion

Percutaneous pedicle screw implantation

INTRADISCAL PROCEDURES

Establish Access channel to posterolateraldisc

Osman et al.: Posterolateral Arthroscopic Discectomies of the Thoracic and Lumbar Spine. Clinical Ortho. & Related Research: 304:122-129, 1994.

Osman SG, et al. Endoscopic Transiliac Approach to L5-S1 Disc and Foramen –A Cadaver Study. Spine, Vol 22, #11:1259, 1997.

Osman SG, et al. Transforaminal and Posterior Decompression of Lumbar spine –A comparative study of Stability and IVF Area. Spine: Vol 22, #15: 1690 - 95

ARTHROSCOPIC DISCECTOMY

Postero-lateral approach

ARTHROSCOPIC DISCECTOMY

Foraminal Space Posterolat view of Kambin’sTriangle

ARTHROSCOPIC MICRODISCECTOMY

Mid- Interpedicular placement Lateral placement

Arthroscopic discectomy & end-plate preparation

Endplate PreparationExpandable Reamer System

Endplate Preparation

Expandable Reamer System

Endplate Preparation

Expandable Reamer System

Endplate Preparation

Interbody Grafting

Interbody Graft Material:

Rh-BMP-2

Allograft Bone Chips

Interbody Grafting

Results

Results

# of cases = 60

Mean age= 52. 7 years

Age range = 26 – 85 years.

Age Groups:

20-30y = 3

31-50y = 25

51-70y = 20

71-90y = 120

5

10

15

20

25

Patient #

20-30 y

31-50 y

51-70 y

71-90 y

Duration of illness:

Mean= 5 years

Range = 2m – 32 years

Follow-up:

Mean 12 months

Range 6 – 25 months

Results

Complaints:

Back pain = 60

Leg pain = 60

Fusion Levels

L1-S1 2

L2-3 1

L2-4 3

L2-5 1

L2-S1 1

L3-5 9

L3-S1 6

L4-5 8

* L4-S1 16

* L5-S1 130

2

4

6

8

10

12

14

16

L1-S1

L2-3

L2-4

L2-5

L3-5

L3-S1

L4-5

L4-S1

L5-S1

Fixation Device

Implants used:

* Denali (K2M) 19

SpheRx (Nuv) 6

Pathfinder (AS) 18

Sextant (Sofam) 17

0

5

10

15

20

Denali

SpheRx

Pathfinder

Sextant

Total OR Time

28 patients

Mean = 174 min

Range = 117 – 250.8 min

Total OR Time

1 level (7) = 2.5 hr.

2 levels (13) = 2.8 hrs.

3 levels (5) = 3.3 hrs.

4 levels (2) = 3.05 hrs

5 levels (1) = 4.1 hrs.

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

Hours

1 level

2 levels

3 levels

4 levels

5 levels

Estimated Blood Loss

Mean 57.6 cc

Range 30 – 100 cc

Blood Loss vs # of Fused segments

1 Level (20) 47.8 cc

2 levels (31) 64.4 cc

3 levels (7) 61.4 cc

4 levels (1) 75.0 cc

5 levels (2) 62.5 cc

0

10

20

30

40

50

60

70

80

1 Level

2 Levels

3 Levels

4 Levels

5 Levels

Length of Hospital Stay

Mean : 2.6 days

Range : 1-12 days

Hospital Stay vs # Fused Seg

1 level (20) 1.7 days

2 levels(21) 3.0 days

3 levels (8) 3.6 days

4 levels (1) 4.0 days

* 5 levels (12) 12.0 days

0

2

4

6

8

10

12

Days

1 level

2 levels

3 levels

4 levels

5 levels

Back Pain

Pre-op on VAS:

Mean : 7.5

Range: 0 – 10

At Last Follow-up:

Mean : 2

Range: 0 - 8

0

1

2

3

4

5

6

7

8

Back Pain

Pre-op

Follow-up

Leg Pain

Pre-op on VAS:

Mean: 7.0

Range: 0 – 10

At Follow-up:

Mean : 1.7

Range: 0 - 5

0

1

2

3

4

5

6

7

Leg Pain

Pre-op

Follow-up

Prior Back Surgery

Decompressions = 10

One Level = 5

Two Levels = 5

Prior Back Surgery

Back Pain /Leg Pain

All :

Preop: 7.5/7.0

Postop: 2.0/1.7

Failed Back:

Preop: 7.0/8.0

Postop: 0.8/0.6

0

1

2

3

4

5

6

7

8

ALL FailedBack

Preop BP

Postop BP

Preop LP

Postop LP

Prior Back Surgery

Hospital stay

All : 2.0 days

Failed Bk: 1.8 days

1.7

1.75

1.8

1.85

1.9

1.95

2

Hosp. Days

ALL

Failed Bk

Post-op Images

45 sets reviewed

28 solid fusion

15 stable constructs

2 cases of osteolysis

around pedicle screws

0

5

10

15

20

25

30

FUSED

STABLE

LOOSE HW

HW BREAK

Post-operative Imaging Studies

3 months post-op 6 months post-op

Complications:

1 medial penetration of S1 pedicle with irritation of S1 nerve root - revised

1 case of painful loose pedicle screws – Removal.

Comparative Data

OR TIME(min)

EBL(ml)

LOS(Days)

COMPLICATIONRATES (%)

LINDIF 174* 57.6 2.6 1.8

X-LIF+/- Post. ins

165 119 3.4 13.3

MIS TLIF 230.2 264.7 5.6 5.6

OPEN PLIF/ TLIF

213.9 693 8.1 4.9

CONCLUSION

LINDIF minimizes surgical trauma:

Avoids violation of natural cavities –

spinal, peritoneal, thoracic

Avoids excision of the facet joint

Avoids the Psoas Space

Avoids retroperitoneal space

Reduced Surgery time

Reduced Blood loss

Short Hospital stay

Minimal rate of complications

Good symptomatic relief

Walking 3 hrs post-op

CONCLUSION

VERY WELL TOLERATED BY ELDERLY PATIENTS

LEAST STRESSFUL FOR THE SURGICAL TEAM

CONCLUSION

Randomized Controlled Trial (RCT) is needed to determine:

Accuracy of above findings

Cost-Effectiveness Analysis

Reduction in rehab duration

Earlier return to prior occupation/recreation

Complication compared with open & other MIS procedures.

Bibliography

Osman et al.: Posterolateral Arthroscopic Discectomies of the Thoracic and Lumbar Spine. Clinical Ortho. & Related Research: 304:122-129, 1994.

Osman SG, et al. . Endoscopic Transiliac Approach to L5-S1 Disc and Foramen –A Cadaver Study. Spine: 22, #11:1259, 1997.

Kambin P. Arthroscopic Microdiscectomy. Arthroscopy 1992; 8:287-295.

Deluzio et al. Value and cost in less invasive spinal fusion surgery: lessons learned from a community hospital. SAS J 2010; 4:37-40.

Knight RQ et al. Direct lateral lumbar interbody fusion for degenerative condition: early complication profile. J Spinal Disord Tech 2009; 22:34-7.

Oliviera L. et al. The use rh-BMP2 in stand alone extreme lateral interbody fusion (X-LIF): clinical and radiological results after 24 months follow-up. World Spinal Column J 2010; 1:19-25.

Ozgur BW et al. Two year clinical and radiographic success of minimally invasive lateral transpsoas approach for the treatment of degenerative lumbar conditions. SAS J 2010. 4:41-6.

Rogers WB et al. Minimally invasive treatment (XLIF) of adjacent segment disease after prior lumbar fusions. Internet J Minimally Invasive Spinal Technol, 2010.; 3.

Anand N et al. Mid-term and long-term clinical and functional outcomes of minimally invasive correction and fusion for adults with scoliosis. Neurosurg Focus 2010; 28:E6

Dakwar E et al. Early outcomes and safely of minimally invasive, lateral retroperitoneal transpsoas approach for the adult degenerative scoliosis. Neurosurg Focus 2010; 28:E8

Villavicencio AT et al. Minimally invasive versus open transforaminal lumbar interbody fusion. SurgNeurol. Int 2010; 1:12.

Wang et al. Comparison of one level minimally invasive and open transforaminal lumbar interbodyfusion in degenerative and spondylolisthesis grade 1 and 2. Euro Spine J 2010; 19:1780-4

Schizas et al. Minimally invasive versus open transforaminal lumbar interbody fusion; evaluating initial experience. Int Ortho 2009; 33:1693-8

Thanks