Lumbar HNP & Radiculopathy When to operate? John G. Heller, MD Baur Professor of Orthopaedic Surgery Fellowship Director Emory Spine Center John Rodriguez-Feo, MD Clinical Instructor
• Multicenter, prospective, randomized trial • 283 patients with 6-12 weeks of sciatica were randomized to microdiscectomy vs continued conservative treatment • 125/141 underwent microdisectomy after 2.2 weeks from randomization • 55/142 randomized to conservative treatment underwent microdisectomy after a mean of 18. weeks. 39% Crossover! • Intent to treat analysis • Relief of leg pain was faster for patients assigned to early surgery • The one year outcomes were similar between the two groups but the rates of pain relief and of perceived recovery were faster for the assigned to early surgery • 95% of both groups reported satisfactory recovery by the end of 52 weeks • Median time to recovery was 4 weeks for early surgery vs 12.1 weeks for prolonged conservative treatment. • Time to work – early surgery vs conservative group • Median 1.9 weeks vs 14.6 weeks
• Prospective cohort study • 10 year outcomes of 400/477 patients • 217/255 treated surgically • 183/222 treated non-surgically • By 10 years, 25 % of surgical patient had undergone at least one additional lumbar spine procedure and 25% of nonsurgical patients had at least one lumbar spine procedure. • Similar improvement in predominant symptom as well as work and disability outcomes between surgery and conservative treatment groups but surgical patients had more complete relief of leg pain and improved function and satisfaction over 10 years.
• Prospective consecutive cohort • 205/219 patients with mean of 9.9 months follow up. • Statistically significant predictors for unfavorable outcomes were longer duration of preoperative pain, motor and sensory deficits. • Overall outcome seems to be better with surgery within 2 months of symptoms and sensory deficits. • No difference between 30 & 60 days.
• Prospective study to determine the 1 and 6 month result of surgery for lumbar disc herniation and factors predicting results before or at operation. • Decision to operate: • Absolute: cauda equina, acute massive paresis, intractable pain • Elective: failed some weeks of conservative treatment, disc herniation on rhizography • 220/220 patients with 1 month follow up and 215/220 with 6 month follow up. • With regard to duration of pre-operative symptoms, the best results were in patients with <2 months of symptoms. • Factors predicting poor outcome: patient’s desire to retire after operation, marital status, abundant somatic nonspecific complaints, age >40, and long duration of sciatica and a long duration of preoperative sciatica.
• Prospective cohort study • 132 patients whom underwent microdiscectomy for Lumbar disc herniation • 12 month follow up assessed pain, clinical examinations (neurological deficits, etc), functional status (Oswestry Low Back Pain Disability Questionnaire), ongoing analgesics use. • Results/Conclusions • Leg pain lasting >8 months correlated with unfavorable postoperative outcome • Patients with >28 weeks of sick leave pre-operatively had a high risk of not returning to work.
• Prospective cohort study • 103/113 patients available for 1 year follow up • Results suggest that symptoms for >12 months have less favorable outcomes.
Worse results after prolonged conservative treatment compared to surgery • Best results in patients with duration of sciatica from 0-3 months and worse >10 months • Blazhevski B, Flilipche V, Cvetanovski V, Simonovska N. Predictive value of the duration of sciatica for lumbar discectomy. Prilozi. 2008; 29(2):325-35.
• Multicenter, prospective, randomized trial • Patients with at least 6 weeks of imaging confirmed lumbar disc herniation • Outcomes measures collected at: • 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment • Primary out measures: • SF-36 • MODEMS version of ODI • Secondary outcomes measures: • Self reported improvement • Work status • Satisfaction with current symptoms and care • Sciatica Bothersomeness Index
• 501 patients enrolled and 1 year follow up with 472 (94%) • 50% of patients assigned to surgery received surgery within 3 months • 59% at 1 year and 60% at 2 years had surgery • Those more likely to cross over to receive nonoperative care: older, higher incomes, more likely to have an upper lumbar disk herniation, less likely to have a positive straight leg– raise, had less pain, better physical function, less disability on the ODI, more likely to rate their symptoms as getting better at enrollment • 30% of patients assigned to nonoperative treatment received surgery within 3 months • 43% at one year and 45% at 2 years had surgery. • Those more likely to cross over to receive surgery : lower incomes, worse baseline symptoms, more baseline disability on the ODI, and were more likely to rate their symptoms as getting worse at enrollment
• Intent to treat analysis: • no statistically significant treatment effects for the primary outcomes • the secondary measures of sciatica severity and self reported progress did show statistically significant advantages for surgery • As treated: • Statistically significant advantages seen for surgery at all follow-up times through 2 years
• In a combined (randomized and observation cohorts) as-treated analysis at 4 years, patients who underwent surgery for a lumbar disc herniation achieved greater improvement than non-operatively treated patients in all primary and secondary outcomes except work status. • At 4 years, the adjusted percentage of patients working was 84.4% surgical versus 78.4% non-operative
• QALY: • Surgery = 1.64 • Non-operative = 1.44 • Cost per QALY gained for surgical treatment v. non-op care (ICER): • Commercial Insurance: $69,403 • Medicare: $34,355
• Pearl Diver database • Cost of care for 90 days prior to surgery: • ~$3,445 per patient • Equally split between diagnostic & therapeutic • Cost of discectomy: $7,841 Spine Journal 2010
Real World Circumstances • HNP sustained in the course of normal daily life. • HNP sustained with injury at work. • HNP sustained during an MVA. What might come of these three different hypothetical folks in the real world today?
John Doe gets HNP while doing yard chores… • Tries rest, OTC meds, comes home from the office due to pain. • Sees 1 0 MD: • Oral steroids, Tramadol and Flexeril. • PT referral. • Work excuse. • No sustained relief: Referred to Pain Management: • ESI #1: Partial benefit • ESI #2: Still miserable • Consults a spine surgeon: Microdiscectomy
Jane Doe lifts a box at work… • Sees the W/Comp. panel with acute severe LBP: • Oral steroids, Tramadol and Flexeril. • PT referral. • Work excuse. • Repeated F/U with panel doc: • More of the same. • Remains miserable. • Referred for ESIs • After a few ESIs, facet blocks, MBBs and bilateral RFAs she’s not sig. better. • And let’s not forget the OPIATES! • Surgical referral (Approval is delayed). Retains an attorney. • Surgical consultation: Surgery recommended • Approval awaits hearing with W/Comp judge. • More time off from work • Angry, frustrated patient receiving compensation. • Eventually gets a microdiscectomy
Mr. Commuter is rear-ended by an city bus during rush hour… • Acute severe LBP and leg pain at scene. • EMS transport to ER. • Oral steroids, Tramadol and Flexeril. • PT referral. • Work excuse. • Retains a personal injury attorney (name & phone number were on the side of the bus): • Referred to chiropractor by attorney. Sees him 5 days/week for 8-12 weeks. • Still miserable. Attorney refers him to preferred Pain Specialist: • After a few ESIs, facet blocks, MBBs and bilateral RFAs she’s not sig. better. • Surgical referral by attorney: • Microdiscectomy recommended. Estimated charges $120,000!!! • Surgery performed. • Auto med pay policy stuck with the bill
Real World Circumstances: What ought we to do for these people? • HNP sustained in the course of normal daily life. • Reasonable course as it played out. People in control of their own destiny will do what they need to do in order to restore their lifestyle/function • HNP sustained with injury at work. • “The System” treats these people differently: Viewed with skepticism. • Delay/deny tactics hurt everyone, especially the employee and employer. • Less satisfactory outcomes for all. • Defined protocols & timelines for care with exceptions for outliers. • Avoid manufacturing problems. Get them back in the game ASAP! • HNP sustained during an MVA. • A rapidly emerging blight on our profession. • Venture capital funds for the uninsured in this scenario! • Unethical collusion between legal & medical profession. • No oversight for “medical necessity” or “usual & customary fees” • Patient, auto insurance company & we are the victims!
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