1. Surgical Management of Back Pain?
Kevin A. Walter, M.D.
Professor of Neurosurgery and Oncology
Chief of Neurosurgery, Highland Hospital
University of Rochester Medical Center

2. Conflicts of Interest
None

3. Why Not Move to Bend, Oregon?

4. Annual U.S. Spine Care $90 billion ($15B fusion). Over the past decade
Incidence has increased by 34%
Cost has increased by 65% (10-fold increase surgery)

6. The National Picture of Spine Care
U.S. Spine Fusion Rates
Significant increase in spine surgery over last decade
No paralleled improvements in patient outcomes

7. The National Picture of Spine Care
Increased Cost of care
We have to define the value of this care

8. Variation in Spine Care
Variation in spine surgery exceeds other treatments

9. Variation in Spine Care
Causes of Variation:
o High prevalence of LBP in population without appropriate clinical guidelines
o Patient Expectation/Preference
o Surgeon Based Decision Making
We need to understand variation in care

10. Spine Care in Upstate New York
Bend, Oregon=8.7 per 1,000 (3rd highest rate in the country)

11. Health Plan Fusion Rates: 2007-2013

12. Spine Care in New York
2010 Spine Fusion Procedures by DRG
All Fusions
County
Sum of Count
Per Fusion Cost
Fusions/ people
Buffalo
Erie & Niagara
2263 $
50,937.53
199.29
Binghamton
Broome & Tioga
500
51,116.82
198.63
Rochester
Monroe
1020
33,306.09
137.03
Albany
Albany & Rensselaer
625
49,628.84
134.80
Syracuse
Madison, Oswego, & Onondaga
751
49,263.98
113.35
New York
20524
68,392.57
105.91
United States
436635
86,179.01
141.42
We have a LOW COST of fusion but a HIGH RATE of fusion
surgery compared to NYS as a whole

13. What treatments are used in Rochester?

14. How much do we spend in Rochester?

15. Fortunately when you whittle it down to RCT’s of surgery vs
Fortunately when you whittle it down to RCT’s of surgery vs. non-surgery for LBP with DDD (excluding lysis, listhesis or stenosis) you get 6 RCT with varying inclusion/exclusion criteria, results and criticisms; I’m going to do my best to briefly review these. Some in more detail than others.

16. Landmark trial of fusion vs. physical therapy
N = 294 patients (25-65 years); 19 spine centers; 6 years
Inclusion criteria
Back pain > leg pain for at least 2 years failing nonsurgical treatment
Source of pain deemed to be L4-5, L5-S1, or both
Surgeon’s interpretation of H&P and radiographic studies
Radiography: X-ray, CT or MRI
Exclusion criteria
Psychiatric illness (active)
Spine surgery w/in 2 years (diskectomy only)
Spine comorbidities (listhesis, lysis, infection, neoplasm, stenosis, radiculopathy)
Hip disease
Other
Unemployed, WC, or ongoing litigation related to back was allowed
Discography, facet blocks, braces were allowed; Use varied
From what I can tell, this 2001 paper published by The Swedish study group was the first large, randomized controlled trial comparing fusion to non-surgical treatment of LBP 2/2 DDD
Other things people might be interested to know
Herniated disks were allowed if no signs (weakness or sensory loss) of root compression; Not excluded: Unemployed, compensation, or litigation related to back pain/condition; Allowed diagnostic tests in some patients at he discretion of the treating surgeon: Discography, external fixation, facet blocks, braces

17. Fritzell et al. continued
Highlights of study design
Randomized into 1 of 4 treatment groups
Surgery (N = 222)
PLF – iliac crest autograft, no internal fixation
PLF + hardware – Same as above with internal fixation
“Circumferential” group – ALIF or PLIF
Nonsurgical treatment (N = 72)
PT +/- modification by locals
Primary outcomes
Pain (back and leg)
VAS (0-100 points) – used mean of max, min, current
Disability
ODI: 0-100% disability
Million Visual Analogue Score: 0-100mm scale
General Function Score (GFS)
Intention to treat analysis
“Group changers”: Results attributed to originally assigned group
Modifications to nonsurgical group could include: PT, education, TENS, acupuncture, injections, cognitive training – aimed at being generalizable to society
ODI: back related disability questionaire with physical and social restriction through 10 questions asking about daily life
Million VAS: 15 questions horizontal scale 0 is no disability and 100 is worst possible disability
GFS

18. Fritzell et al. continued
Results
98% (288/294) follow-up at 2 years; 25 “group changers”
Pain
Surgery: greater reduction in back and leg pain at all time points
Back pain after surgery increased between 6 months-2 yrs
Disability
All measures (ODI, Million, GFS) showed greater reduction with surgery
Patient assessment
Surgery 63% overall “improved” vs. Nonsurgery 29% (P<0.0001)
Independent blinded observer assessment
Surgery: 45% “improved” vs. Nonsurgery: 18% (P<0.005)
No difference between fusion technique for any outcome

20. “There were no obvious complications in the nonsurgical group, but three patients threatened to commit suicide if they did not have an operation.”
Complications were split into 2 groups: early (< 2 weeks) and late; 16 reoperations (*) for various reasons; No obvious complications in the patients assigned to nonsurgery save for the 3 patients who threatened suicide if they didn’t get surgery

21. Fritzell et al - Conclusion
“In this multicenter, randomized, controlled trial conducted on a comparably well-defined patient group with severe CLBP and with radiographic signs of disc degeneration and spondylosis, the improvement of pain and disability after surgical fusion was significantly superior to that of the nonsurgical treatments used. We conclude that lumbar fusion can be used to reduce pain and decrease disability in carefully selected and well-informed patients suffering from CLBP.”
Conclusion was that in carefully selected and well-informed patients fusion was superior to nonsurgical treatment (PT)
From what I can gather this was good news for spine surgeons at the time and reason to rejoice

23. Criticism of Fritzell et al.
Nature of the control/nonsurgical treatment
70 hours of PT over 2 years and surgeon follow-up
Other methods of nonsurgical treatment could be used, but not required
More rigorous rehabilitation program should have been used for all nonsurgical patients
Resistance exercises and cognitive/behavioral therapy
This study was met with a lot of criticism and the most of it was aimed at the control group requirements…..basically telling these 72 patients that they would continue to receive the PT that didn’t work for them in the first place and see how they do, in spite of other evidence showing benefit of more rigorous rehab utilizing cognitive therapy and resistance exercises.

24. Objective Patients and methods
Compare lumbar instrumented fusion with cognitive intervention and exercises in CLBP and DDD
Patients and methods
25-60 years with CLBP and DDD at 1 or 2 levels (L4-S1)
All fusion patients underwent PLF with pedicle screws
Cognitive intervention and exercises group (25 hours/wk)
Lectures to encourage back use and bending (fear avoidance)
Physical exercises 3x/week x 3 weeks
Similar outcomes measured to the Swedish group
Intention to treat analysis
With these criticisms in mind after the Swedish trial, the Norwegians published a series of studies starting in 2003 with this paper. Essentially same trial design with a few highlighted differences

25. Brox et al 2003 - Results 97% (61/64) follow-up at 1 year
No significant differences in any major outcome measures
Pain
Disability
Patient rating
Independent observer rating
Return to work
Secondary measures
Favoring surgery group
Leg pain reduction
Favoring nonsurgical group
Fear avoidance
Fingertip to floor distance
Fusion rate: 84%
Complications (6/33 patients)
Wound infection (2)
Bleeding (2)
Durotomy (1)
DVT (1)

27. Brox et al Conclusion
“It was concluded that after 1 year of follow-up, the difference between the groups given lumbar instrumented fusion and cognitive intervention and exercise was neither clinically important nor significant. Most cases of CLBP can be managed by cognitive intervention and exercise, with lumbar fusion as a more expensive alternative.”

28. Trials Favoring Nonsurgical Treatment
} Underpowered
Brox et al. Spine (Norway)
Brox et al. Pain (Norway)
N=60; yo LBP x 1yr with previous discectomy
Design per Brox et al protocol
Results at one year
No difference in ODI improvement between groups
47 to 38 for fusion; 45 to 32 for nonsurgical tx
No difference in most secondary outcome measures
Conclusion
“Fusion should not be recommended for patients with CLBP after surgery for disk herniation”
Brox et al. Ann Rheum Dis (Norway)
Combined patients from 2003 and 2006 (total 124 patients)
Mailed questionnaires to determine 4 year outcomes
No difference in ODI improvement or other measures
Fairbank et al. BMJ (UK)
N=349; yo LBP x 1yr
Fusion vs. Intensive rehab
Results at 2 years
ODI favored surgery
Mean Δ b/t groups -4.1
95% CI ; p=0.045
No Δ in shuttle walk, SF-36
“No clear evidence that fusion is more beneficial than rehab”
The same Norwegian groups published two addition papers, one in in patients with CLBP for > 1 year after diskectomy; the rest of the study was very similar to the 2003 study; The results were also very similar finding no difference between fusion and intensive rehab.
One of the biggest criticisms of these trials was that they were not powered enough to detect the projected difference in their primary outcome, the ODI. In 2010 they published 4 year follow-up on patients from both of the previous studies in an attempt to increase power. They obtained the data by mailing questionaires to determine multiple outcomes, the primary outcome being ODI for which they found no difference
Another large trial with mixed results was out of the UK by Fairbank et al. published in BMJ in 2005; despite showing a significant difference in ODI improvement with fusion over intensive rehab, the difference was small, only 4.1 points on the ODI (previous reports note that 10 points are required for significant clinical improvement), and there were no differences in other measures, as well as, the inherent risks of fusion surgery.

29. Another RCT Supporting Fusion
Ohtori et al. Spine. ‘11 (China)
N=41; yo 1 level DLBP
MRI w/ only 1 black disk
Discogram and “Discoblock”
Excluded MVA and WC
Fusion (ALIF or PLF) vs. Nonsurgical
Results at 2 years favored fusion
ODI / VAS / JOA
Conclusion
“If DLBP is strictly diagnosed, fusion is suitable for its treatment”
Criticism
Small sample size
Nonsurgical treatment lacking
There was another RCT which strongly favored fusion over nonsurgical therapy. The other reason to mention it was their required use of diskogram.
DLBP = 1 level disc degen on MRI with positive diskogram (+ provocation and + pain relief with bupivacaine)
Ohtori: Mean duration of low back pain was 7.5 years; DLBP = 1 level disk degen on MRI with positive diskogram (+ provocation and + pain relief with bupivacaine); only at that level (dropped 11 for – relief)
Nonsurgical treatment consisted of walking 30min/session 2 x per day and stretching 15/session 2 x per day; confirmed monthly and excluded if did not comply
Surgery by ALIF was with iliac crest graft and no hardware; PLF only if anterior great vessels were unfavorable for anterior approach, hardware and bone graft, no interbody; all patients showed bony union by CT by 14 months; (JOA = Japanese orthopedic association)

30. Ohtori et al. - Results

31. How does it all add up? Systematic Reviews

32. Multiple objectives of this review Included RCTs up to 2005
31 total RCTs included
Only 2 with regards to fusion vs. nonsurgery for DDD
Conclusion
“Clearly, there are still open questions about the scientific evidence on the clinical effectiveness of fusion. Further evidence is required, which hopefully will be provided by the multicentered RCTs of fusion that are presently underway in the United States and United Kingdom.”
The first was a Cochrane review in 2005 which had multiple objectives of this review including: Techniques used for neural decompression in foraminal and central canal stenosis, techniques for fusion. Included RCTs that used used ITT analysis and blinded outcome assessors. 2 trials of fusion and nonsurgery at time of this writing were Swedish trial and 1st Norwegian trial mixed results

33. Focused on RCTs with patient-reported outcomes
Total of 18 level 1 studies identified
6 of fusion vs. nonsurgery
Pooled results
Conclusion
“The body of literature supports fusion surgery as a viable treatment option for reducing pain and improving function in patients with chronic LBP refractory to nonsurgical care when a diagnosis of disc degeneration
can be made.”
Trials needed at least 2 of: VAS, ODI, SF-36, patient satisfaction with minimum of 12 months follow-up; fusion was for 1 or 2 levels by any approach
6 of fusion vs. non surgery; 12 of alternative surgical procedures
Procedures included PLF w/ and w/o hardware, PLIF, ALIF; non-op was PT or structured rehab with cognitive and/or physical exercise program

34. Real World Care - TLIF Less Costly More effective
Instead of eliminating procedures, refine delivery to best patients & best providers
LowestValue
Less Costly
Highest Value
More effective

35. Real World Care - TLIF Less Costly More effective
Instead of eliminating procedures, refine delivery to more appropriate patient subgroups
LowestValue
Less Costly
Highest Value
More effective

36. N2QOD (n=4500 cases)

37. N2QOD (n=4500 cases)

38. IOM, HHS, AHRQ, PCORI, CMS
Eliminate non-effective care/treatments , purchase only high-value treatments
Financially incentivize providers/hospital to deliver care above quality benchmarks
Goal is to purchase high-value treatments from high quality providers

39. IOM &Federal Coordinating Council for CER prioritization and guidance to conduct CER
Establishment of prospective registries to capture patient-centered data from real-world practice was of highest priority.
Low-back pain and lumbar spine disorders was included in IOM’s highest priority group for CER initiatives

41. Spine Registry Practice Data Collection

43. Standard of Care Outcomes Assessment
(All Surgical Pts, Representative Sampling of Medical patients)

44. Effectiveness of Care

45. Return to Work

46. Era of Comparative Effectiveness

47. Era of Comparative Effectiveness

48. Medical care for Lumbar Pathology
Baseline
1 yr
Baseline
1 yr
Baseline
1 yr
Baseline
1 yr
Baseline
1 yr

49. Spondylolisthesis

50. Lumbar Stenosis

51. Measuring Cost, Quality, and Satisfaction in Real world Care:
The Transparency Factor

53. Do the ends justify the means?
Lumbar fusion can benefit patients with refractory back pain.
Aggressive conservative management may be just as effective, but effectively doesn’t exist in this country.
More rigorous criteria need to exist to stratify patients.