Adult Spinal Deformity Complications Eric Klineberg, MD Associate - - PDF document

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Adult Spinal Deformity Complications Eric Klineberg, MD Associate - - PDF document

Adult Spinal Deformity Complications Eric Klineberg, MD Associate Professor Department of Orthopaedics UC DAVIS University of California, S PINE C ENTER Davis Speaking: AO, Depuy/Synthes Fellowship Funding: Depuy/Synthes, OREF Grants: AO


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SPINE CENTER UC DAVIS

Adult Spinal Deformity

Complications

Eric Klineberg, MD Associate Professor Department of Orthopaedics University of California, Davis

SPINE CENTER UC DAVIS I have no financial interest with any company regarding this subject

Eric Klineberg, MD

Speaking: AO, Depuy/Synthes Fellowship Funding: Depuy/Synthes, OREF Grants: AO Foundation

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Introduction

 Surgical intervention can have a significant

impact

 Complications can be significant SPINE CENTER UC DAVIS

Introduction

Deformity Surgery

– Considered to have higher

risks

– Perioperative complications

are frequent (up to 40%)

Glassman et al. Spine 2007

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What is a complication?

 com·pli·ca·tion  noun \ˌkäm-plə-ˈkā-shən\ : something that

makes something harder to understand, explain, or deal with

 medical : a disease or condition that happens

in addition to another disease or condition : a problem that makes a disease or condition more dangerous or harder to treat

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What is a complication?

Does it matter?

Complication List Infection  Major

  • Deep, Pneumonia, Sepsis

 Minor

  • Superficial, UTI, C Diff infection

Implant  Major

  • Hook dislodgement, Interbody fracture/migration, Rod fracture/dislodgement, Screw fracture

 Minor

  • Painful/promininent, Screw malposition/loosening, Interbody subsidence/dislodgement

Radiographic  Major

  • DJK, PJK, Pseudoarthrosis

 Minor

  • Coronal/Sagittal imbalance, Curve decompensation, HO, Adjacent segment degeneration

Neurologic  Major

  • Visual deficit/blindness, Brachial plexus injury, CVA/Stroke, Spinal cord injury, Nerve root injury

with weakness, Retrograde ejaculation, Bowel/Bladder deficit  Minor

  • Neuropathy or sensory deficit, Pain (radiculopathy), Peripheral nerve palsy, Delirium

Mortality  All major Cardiopulmonary  Major

  • Cardiac arrest, PE, Respiratory arrest, DVT, MI, Reintubation, ARDS

 Minor 

  • Coagulopathy, Arrhythmia, Pleural effusion, Hypotension, CHF

Gastrointestinal  Major

  • Obstruction, Perforation, Bleed requiring surgery, Pancreatitis/Cholecystitis requiring surgery, Liver

Failure, SMA Syndrome  Minor

  • Ileus, Bleed not requiring surgical intervention, Pancreatitis/Cholecystitis no surgery

Renal  Major

  • Acute Renal failure requiring dialysis

 Minor

  • Acute Renal failure requiring medical intervention

Operative  Major

  • Retained sponge/instrument, Wrong surgical level, Unintended extension of fusion, Vascular injury,

Visceral injury, EBL >4L  Minor

  • Dural tear, Fixation failure (hook/screw), Pedicle fracture, Posterior element fracture, Vertebral body

fracture Wound Problems  Major

  • Dehiscence requiring surgery, Hematoma/seroma requiring surgery +/- neurological deficit,

Incisional hernia  Minor

  • Hematoma/seroma not requiring surgery, Hernia
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INTRODUCTION

 Glassman et al

– major and minor complications did not

adversely effect the improvement found in the HRQOL measures

– except for deterioration in the SF-12 for

major complications.

 Theorized that outcome instruments

were not sensitive enough to detect a difference

 Perioperative complications may not

have a continued impact at one year.

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What is a complication?

 Physician and patient dependent

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Prevention

 Medical Optimization

– Cardiac – Pulmonary – Nutritional – Metabolic – Bone Quality – What about consent?

SPINE CENTER UC DAVIS  Informed Consent

 Despite ranking the consent process as

important, patient recall was only 41% immediately after discussion and video re- enforcement.

 Recall subsequently declined to 20% at 6

months post-operatively.

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Prevention

 Medical Optimization

– Cardiac – Pulmonary – Nutritional – Metabolic – Bone Quality

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Cardiac

 Clearance

– Inc risk with:

 Unstable coronary sx  Decompensated CHF  Arrhythmias  Severe valvular disease

 PMH

– MI, CHF, stroke , DM, Renal insuff, poor exercise

tolerence

 Perfusion Studies  Rx: beta blocker

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Pulmonary

 Pre-op

– CXR

 Poor exercise tolerance > 2 min bicycle  PFT  Post-op

– Mobilization – Minimize vent time

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Nutrition

 Pre-op maximize

– Risk factors: < 60yo, DM, Osteomyelitis, SCI – Labs: albumin, pre-albumin, TLC count

 Feed early if possible

– Nutrition Consult – Feeding tube – G-tube

 Take 6-12 weeks for nutrition to return to

baseline

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Metabolic

 Optimize Diabetes

– Serum glucose 110 mg/dL

 Pre-op and intra-op  High blood glucose associated with increase in

complications

– Infection, pneumonia

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Bone Quality

 Pre-operative prevention, treatment

– Osteoporosis < 2.5 STD – Risk factors:

 age > 50, smoking, Caucasian, Hx of Fx

– Rx: Bisphosphonates – Forteo?

 Fracture  PJK vs PJF

– Who needs revision after?

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Intra-Operative

 Blood loss

– TXA, Amicar – Hypotension

 Two Surgeons?

– UCSF group and others

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Surgical Strategy

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Surgical Strategy

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Surgical Strategy

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Do Complications affect HRQoL?

 355 pts prospectively enrolled in the ISSG

multicenter study

 202 met the inclusion criteria  Mean age 57.4, levels fused 12  Four groups identified:

– No Complications

N=84

– Minor Complications

N=87

– Major Complications

N=65

– Both Major and Minor

N=35

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Baseline Pre-OP Demographics

 Similar distribution for Age, BMI, and ASA, as

well as Pre-OP spinopelvic parameters.

 Sig lower Charlson Comorbidity Index for the

no complication group.

  • No

Complications Minor Major Both p-value

  • Age

55.2 57.7 61.1 58.8 0.072

  • BMI

26.9 27.3 28.1 28.4 0.487

  • ASA

2.2 2.4 2.4 2.4 0.06

  • Charlson

1.2 1.9 2.0 1.9 0.015*

  • Smoker

(%) 6 11 8 11 0.693

  • SVA

(mm) 45.6 53.9 68.6 68.5 0.217

  • Max

Cobb (Degrees) 41.5 45.0 41.9 44.2 0.689

  • Prior

Spine Fusion Surgery

(%)

75.0 73.0 80.6 70.6 0.853

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Operative Summary

 Trend towards > PSO for Major and Both complication groups  No complication group also had the lowest percent of BMP,

anterior approach, EBL and Time in the OR.

May be a surrogate for surgical complexity.

  • No

Complications Minor Major

  • Both
  • p-value

Levels Fused 12.0 11.9 12.3 12.4 0.825 Osteotomy (%) 71.1 55.6 71.4 73.0 0.997 PSO/PVCR (%) 22.9 21.1 31.7 29.7 0.413 BMP (%) 51.8% 86.7% 86.5% 69.8% 0.0001 Anterior (%) 14.5 30.0 30.2 40.5 0.013 EBL (cc) 1783 2061 2698 2704 0.005* OR Time (min) 412 494 517 533 0.0001** Length

  • f

Stay (Days) 8.0 8.9 10.5 9.9 0.073

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Baseline/1 Year HRQoL

  • All

Complication No Complication Major Minor Both P values Baseline ODI (Std) 42.5

  • (19.6)

41.3

  • (19.5)

46.4 (17) 39.5 (19.5) 42.5 (16.9) NS 1 year ODI

  • (Std)

28.3

  • (20.2)

26.6

  • (18.6)

29.9 (20) 26.9 (20.0) 28.1 (19.5) NS Baseline PCS (Std) 32.9

  • (10.3)

32.9

  • (9.75)

31.1 (8.8) 33.9 (10.3) 31.8 (9.9) NS 1 year PCS (Std) 39.5

  • (11.1)

41.3

  • (10.9)

38.0 (12) 40.7 (10.8) 39.8 (11.3) NS

  • Significant improvement in All groups from Baseline to 1 year

No differences between groups for any of the outcome measures, regardless of complication

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1 Year HRQoL

Significant impact on ODI and PCS for readmission, reoperation and no complication resolution.

  • No

Readmission Readmission P Value 1 year ODI 24.5 39.5 P < 0.01 1 year PCS 41.3 31.9 P < 0.01

  • No

Reoperation Reoperation

  • 1

year ODI 24.8 37.1 P < 0.01 1 year PCS 41.1 33.9 P < 0.01

  • Resolution

Of Complication No Resolution

  • 1

year ODI 24.5 39.5 P < 0.01 1 year PCS 41.3 31.9 P < 0.01

  • SPINE CENTER

UC DAVIS

Discussion

 We found that baseline metrics were similar for

complication and non-complication groups except for Charslon

 Increased complexity of surgery (BMP, EBL,

OR time) correlated with complications.

– Perhaps a function of increased deformity

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Discussion

 All groups regardless of complication type

encountered or not had a significant improvement in HRQoL at one year

 Improvement in spinal alignment and

decompression far outweighs the complication encountered

– even when that complication is classified as

major.

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Discussion

 We suspect that grouping all of the major

complications, causes a regression towards the mean, and minimizes any one complication.

 Most of the complications are peri-

  • perative or intra-operative

– temporally far removed from the final 1 year

  • utcome instrument.
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Conclusion

 Pre-Operative morbidity does correlate with

increased complications

 Complications classified as either major or

minor are not sufficient to accurately detect significant differences in HRQoL at one year.

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Conclusion

 Reoperation, readmission or incomplete

resolution had poorer one-year HRQoL

 Should be included in any classification

system.

 Further study is needed to assess the

quantitative economic impact of ASD complications

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Prospective Multicenter Assessment of Complication Rates Associated with Adult Spinal Deformity Surgery in 291 Patients with Minimum 2-Year Follow-Up

Justin S. Smith,1 Eric Klineberg,2 Frank Schwab,3 Christopher Shaffrey,1 Shay Bess,2 Greg Mundis,4 Han Jo Kim,3 Justin Scheer,5 Christopher P. Ames,6 International Spine Study Group (ISSG)

1Department of Neurosurgery, University of Virginia Medical Center, Charlottesville, VA, USA; 2University of

California Davis, Sacramento, CA, USA; 3Department of Orthopedic Surgery, Hospital for Special Surgery, New York City, NY, USA; 2Department of Orthopedic Surgery, NYU Hospital for Joint Diseases, New York, NY, USA; 4San Diego Center for Spinal Disorders, La Jolla, California, USA; 5University of California San Diego School of Medicine, La Jolla, CA, USA; 6University of California San Francisco, San Francisco, CA, USA

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  • Previous reports of complication rates limited

by:

  • Surgical treatment can improve pain/disability

for adults with symptomatic spinal deformity, but these procedures have high complication rates.

  • Retrospective design
  • Single surgeon/center cohorts
  • Lack of rigorous complication collection
  • Limited follow-up

Introduction

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  • To prospectively assess rates of

complications associated with ASD surgery with minimum 2-year follow-up

  • Standardized data collection forms
  • On-site study coordinators
  • Regular auditing of data
  • To help ensure complete and accurate

reporting of complications:

Objective

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  • Multi-center, prospective, observational

study of operatively treated adult deformity patients conducted through ISSG

  • Inclusion criteria: Adult (age >18 yrs)

spinal deformity and >1 of following:

  • coronal Cobb > 20o
  • SVA > 5cm
  • pelvic tilt > 25o
  • thoracic kyphosis > 60o

Methods

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ISSG Complication List With Classification

  • Complications

classified:

  • peri-op (<6 wks

from surgery)

  • delayed (>6 wks

from surgery)

  • minor vs major

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All Patients Patient Age (Yrs) 18-44 45-64 65-86 p-value n (%) 291 (100) 56 (19.2) 140 (48.1) 95 (32.6) <0.001 Mean age, yrs (SD) 56.2 (15.2) 30.6 (8.0) 56.4 (4.9) 70.9 (5.3) <0.001 Anterior procedure (%) 74 (25.4) 3 (5.4) 55 (39.3) 16 (16.8) <0.001 Mean levels (SD) 3.1 (1.3) 4.3 (1.5) 3.1 (1.3) 3.0 (1.3) 0.264 Posterior procedure (%) 287 (99) 56 (100) 137 (97.9) 94 (98.9) 0.670 Mean levels (SD) 11.1 (4.5) 9.9 (3.8) 11.8 (4.5) 10.8 (4.8) 0.024 Osteotomy (%) 187 (64.3) 28 (50.0) 96 (68.6) 63 (66.3) 0.044 Pedicle subtraction 47 (16.2) 4 (7.1) 22 (15.7) 21 (22.1) 0.053 Smith-Petersen 147 (50.5) 24 (42.9) 78 (55.7) 45 (47.4) 0.201 Vertebral column 9 (3.1) 1 (1.8) 5 (3.6) 3 (3.2) 0.808

Results: Operative

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Complication Category Peri-op (<6wks) minor/major (%) Delayed (>6wks) minor/major (%) Total minor/major (%) Implant 3/8 (3.8) 11/59 (24.1) 14/67 (27.8) Radiographic 4/10 (4.8) 25/42 (23.0) 29/52 (27.8) Neurologic 21/24 (15.5) 16/20 (12.4) 37/44 (27.8) Operative 41/32 (25.1) 0/1 (0.3) 41/33 (25.4) Cardiopulmonary 31/20 (17.5) 1/3 (1.4) 32/23 (18.9) Infection 11/20 (10.7) 5/7 (4.1) 16/27 (14.8) Gastrointestinal 24/1 (8.6) 0/0 (0) 24/1 (8.6) Wound (excluding infection) 3/7 (3.4) 0/5 (1.7) 3/12 (5.2) Vascular 4/0 (1.4) 1/0 (0.3) 5/0 (1.7) Musculoskeletal 0/0 (0) 3/0 (1.0) 3/0 (1.0) Renal 1/2 (1.0) 0/0 (0) 1/2 (1.0) Other 2/1 (1.0) 0/0 (0) 2/1 (1.0) Total (minor/major) 270 (145/125) 199 (62/137) 469 (207/262) Mean # complications/patient (minor/major) 0.93 (0.50/0.43) 0.68 (0.21/0.47) 1.61 (0.71/0/90) Number of patients affected (%) 150 (51.5) 124 (42.6) 203 (69.8)

Results: 246 patients with 2 year f/u

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Complication Category Peri-op (<6wks) minor/major (%) Delayed (>6wks) minor/major (%) Total minor/major (%) Implant 3/8 (3.8) 11/59 (24.1) 14/67 (27.8) Radiographic 4/10 (4.8) 25/42 (23.0) 29/52 (27.8) Neurologic 21/24 (15.5) 16/20 (12.4) 37/44 (27.8) Operative 41/32 (25.1) 0/1 (0.3) 41/33 (25.4) Cardiopulmonary 31/20 (17.5) 1/3 (1.4) 32/23 (18.9) Infection 11/20 (10.7) 5/7 (4.1) 16/27 (14.8) Gastrointestinal 24/1 (8.6) 0/0 (0) 24/1 (8.6) Wound (excluding infection) 3/7 (3.4) 0/5 (1.7) 3/12 (5.2) Vascular 4/0 (1.4) 1/0 (0.3) 5/0 (1.7) Musculoskeletal 0/0 (0) 3/0 (1.0) 3/0 (1.0) Renal 1/2 (1.0) 0/0 (0) 1/2 (1.0) Other 2/1 (1.0) 0/0 (0) 2/1 (1.0) Total (minor/major) 270 (145/125) 199 (62/137) 469 (207/262) Mean # complications/patient (minor/major) 0.93 (0.50/0.43) 0.68 (0.21/0.47) 1.61 (0.71/0/90) Number of patients affected (%) 150 (51.5) 124 (42.6) 203 (69.8)

Results: 246 patients with 2 year f/u

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Complication Categories and Subgroups Peri-op (<6wks) minor/major Delayed (>6wks) minor/major Total minor/major (%) Implant, minor/major (%) 3/8 (3.8) 11/59 (24.1) 14/67 (27.8) Rod breakage 0/1 (1 re-op) 0/39 (14 re-op) 0/40 (13.7) Implant prominence 0/1 6/4 (4 re-op) 6/5 (3.8) Painful implant 0/0 2/5 (5 re-op) 2/5 (2.4) Screw breakage 0/1 0/5 (1 re-op) 0/6 (2.1) Screw loosening 1/1 (1 re-op) 3/1 4/2 (2.1) Interbody spacer dislodgement 0/2 (1 re-op) 0/1 0/3 (1.0) Screw medial breach 1/0 0/1 (1 re-op) 1/1 (0.7) Implant failure 0/0 0/1 (1 re-op) 0/1 (0.3) Rod dislodgment 0/0 0/1 (1 re-op) 0/1 (0.3) Screw dislodgement 0/0 0/1 (1 re-op) 0/1 (0.3) Crosslink dislodgement 1/0 0/0 1/0 (0.3) Fixation failure 0/1 (1 re-op) 0/0 0/1 (0.3) Hook dislodgement 0/1 0/0 0/1 (0.3) Radiographic, minor/major (%) 4/10 (4.8) 25/42 (23.0) 29/52 (27.8) Proximal junctional kyphosis 3/8 (6 re-op) 15/13 (12 re-op) 18/21 (13.4) Pseudarthrosis 0/0 0/15 (10 re-op) 0/15 (5.2) Adjacent segment disease 0/0 6/4 (2 re-op) 6/4 (3.4) Coronal imbalance 1/2 (2 re-op) 3/2 (2 re-op) 4/4 (2.7) Sagittal imbalance 0/0 1/4 (3 re-op) 1/4 (1.7) Distal junctional kyphosis 0/0 0/4 (2 re-op) 0/4 (1.4)

Implant and Radiographic

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Complication Category and Subgroups Peri-op (<6wks) minor/major Delayed (>6wks) minor/major Total minor/major (%) Neurologic, minor/major (%) 21/24 (15.5) 16/20 (12.4) 37/44 (27.8) Radiculopathy 3/6 (3 re-op) 10/7 (4 re-op) 13/13 (8.9) Motor deficit 0/7 (2 re-op) 0/7 (5 re-op) 0/14 (4.8) Sensory deficit 4/0 4/3 (3 re-op) 8/3 (3.8) Nerve root injury 3/4 (2 re-op) 0/1 3/5 (2.7) Mental status change 5/0 0/0 5/0 (1.7) Stroke 0/1 0/1 0/2 (0.7) Bowel/bladder deficit 0/2 0/0 0/2 (0.7) Femoral neuralgia 2/0 0/0 2/0 (0.7) Myelopathy 0/0 0/1 (1 re-op) 0/1 (0.3) Peroneal nerve palsy 0/1 0/0 0/1 (0.3) Other 4/3 (1 re-op) 2/0 6/3 (3.1)

Neurologic

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Complication Categories and Subgroups Peri-op (<6wks) minor/major Delayed (>6wks) minor/major Total minor/major (%) Operative, minor/major (%) 41/32 (25.1) 0/1 (0.3) 41/33 (25.4) Excessive bleeding 6/26 0/0 6/26 (11.0) Dural tear 30/1 0/0 30/1 (10.7) Monitoring anomaly 4/4 0/0 4/4 (2.7) Bowel perforation 0/1 0/0 0/1 (0.3) Pedicle fracture 0/0 0/1 0/1 (0.3) Vertebra fracture 1/0 0/0 1/0 (0.3) Vascular injury 0/0 0/0 0/0 (0.0) Cardiopulmonary, minor/major (%) 31/20 (17.5) 1/3 (1.4) 32/23 (18.9) Pleural effusion 21/1 (1 re-op) 0/1 21/2 (7.9) Arrhythmia 5/1 1/0 6/1 (2.4) Pulmonary other 3/4 0/0 3/4 (2.4) Pulmonary embolism 0/5 0/1 0/6 (2.1) Deep venous thrombosis 0/6 0/0 0/6 (2.1) Congestive heart failure 0/0 0/1 0/1 (0.3) Myocardial infarction 0/1 0/0 0/1 (0.3) Reintubation 0/1 0/0 0/1 (0.3) Other 2/1 0/0 2/1 (1.0)

Operative and Cardiopulmonary

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Complication Categories and Subgroups Peri-op (<6wks) minor/major Delayed (>6wks) minor/major Total minor/major (%) Infection, minor/major (%) 11/20 (10.7) 5/7 (4.1) 16/27 (14.8) Deep wound infection 0/11 (8 re-op) 0/7 (5 re-op) 0/18 (6.2) Urinary tract infection 7/0 1/0 8/0 (2.7) Pneumonia 0/4 0/0 0/4 (1.4) Superficial 2/1 1/0 3/1 (1.4) Sepsis 0/3 0/0 0/3 (1.0) Other 2/1 (1 re-op) 3/0 5/1 (2.1)

Infection and Wound Complication

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Percentage of Patients Number of Complications All Patients

Results: Clustering

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Percentage of Patients Affected

Type of Complication

P=0.009* P=0.605 P=0.009* P=0.252 P=0.179

Complication Rate and Age

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Peri-op Complication? Delayed Complication? No Yes p-value No Yes p-value Female (%) 47.7 52.3 0.255 58.5 41.5 0.428 Mean BMI (SD) 26.3 (5.9) 28.2 (6.2) 0.015 26.6 (6.3) 28.2 (5.8) 0.031 Mean CCI (SD) 1.1 (1.4) 1.7 (1.7) 0.002 1.2 (1.5) 1.7 (1.7) 0.007 Mean ASA (SD) 2.3 (0.7) 2.3 (0.6) 0.405 2.2 (0.7) 2.4 (0.6) 0.006 Current smoker (%) 44.0 56.0 0.680 56.0 44.0 1.000 Previous spine surgery (%) 48.5 51.5 1.000 52.3 47.7 0.095 Previous spine fusion (%) 44.4 55.5 0.029 54.5 45.5 1.000 Combined A-P procedure (%) 43.8 56.2 0.417 56.2 43.8 0.891 3-column osteotomy (%) 37.5 62.5 0.075 44.6 55.3 0.036

Complications and Correlations

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Implant

Radiographic

Operative Infection

#1. Rod Fracture Accessory and satellite rods reduce rod fractures across 3COs.

Complications and Advancements

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Implant

Radiographic

Operative Infection

#1. Rod Fracture #1. PJK/PJF

Tethers and techniques to support junctions Management strategies

Complications and Advancements

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Implant

Radiographic

Operative Infection

#1. Rod Fracture #1. PJK/PJF #1. Excessive blood loss TXA lowers intra-

  • p blood loss

Complications and Advancements

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Implant

Radiographic

Operative Infection

#1. Rod Fracture #1. PJK/PJF #1. Excessive blood loss #1. Deep wound infection

Vancomycin powder may reduce infection rates

Complications and Advancements

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  • Many (if not most) complications likely have

minimal or no impact on ultimate patient

  • utcome.
  • Most common complications were in 6

categories: implant-related, radiographic, neurologic, operative, cardiopulmonary, and infection.

  • Although surgical treatment for ASD can

improve pain and disability, it is associated with high rates of complications.

Conclusion

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SPINE CENTER UC DAVIS  Pre-operative planning is important

– Radiographic and Medical – Deformity ≠ Surgery – Significant number of complications – Not all are created equal, and may be different for

you and your patient

Conclusion