Postoperative Rehabilitation following Lumbar Disc Arthroplasty A Clinical Reasoning & Best Evidence Approach Outline Prevalence Indications for lumbar disc arthroplasty Surgical procedures Post-op rehabilitation Emilio Louie Puentedura, PT, DPT Board Certified Specialist in Orthopedic Physical Therapy Fellow of the American Academy of Orthopedic Manual Physical Therapists Assistant Professor UNLV Dept. of PT Instructor International Spine Pain Institute, USA Instructor Neuro Orthopedic Institute, USA Spinal Surgery in the US 350 300 250 200 150 100 50 0 <18 18-44 45-64 > 64 All inpatient back surgeries, by age, in thousands for 2001 CMS data Surgery Stats Elective lumbar spine surgery rates decreased by 2% in one year 1 Costs increased by 6.8% 1 Back surgery (not fusion) Back fusion surgery Totals DRG 499 500 497 498 2005 35,159 46,742 33,214 21,973 137,088 Avg Cost $26,631 $17,541 $73,209 $55,493 $172,874 2006 34,477 44,733 32,665 22,230 134,105 Avg Cost $28,645 $19,615 $76,011 $60,406 $184,667 Top 30 Elective Inpatient Hospital DRGs, 2005 and 2006 data 1 An international comparison showed that the rate of back surgery in the United States was at least 40% higher than in any other country and was more than five times those in England and Scotland 2 Why? Back pain is a universal phenomenon in the world Can treatment for LBP be sub-standard in the US? Maybe the opposite? Information from Centers for Medicare & Medicaid Services (CMS) http://www.cms.hhs.gov copied without permission 1
Ratio of rates for back surgery in the US average Spinal Surgery in the US Deyo et al 4 showed that the greatest predictor of surgery was the number of surgeons in the local population Substantiated by studies linking availability of high-tech scanning g devices and surgeons to rates of spinal surgery in different areas of the country Lower rates for back surgery observed in East coast, while highest rates of spinal surgery are recorded on the West coast 4 From: Weinstein et al 3 Can it be that your zip code is the deciding factor in determining if you undergo spinal surgery? Show me the money? What if surgeons can profit from spinal implants and devices? Spinal surgery reimbursement higher for orthopedic and neurosurgeons compared to most other surgical procedures they perform 4 A good example late 80 s WA state implemented new workman s comp program with more stringent t guidelines for use and payment tfor back fusions Rate of fusions immediately declined by 33% whereas other spine surgery rates stayed unchanged The market for spinal implants and devices is estimated at $2 billion per year, with an annual growth of 18 20% per year Riding the gravy train? Diagnosis & Indication for Surgery? In a recent study, Mitchell 5 compared utilization rates for complex and simple spinal fusion procedures in Oklahoma and three other states with a high concentration of physicianowned specialty hospitals (KS, SD, and AZ) to utilization rates for back surgery performed on Medicare patients t who reside in the Northeast region Entry of physician-owned specialty hospitals followed by substantial increases in the market area utilization rates for complex spinal fusion surgery copied without permission 2
Spinal Fusion Courtesy of Tim Flynn, PT, PhD CSM 2008 Nashville Artificial Discs - What's on the Horizon? Today, there are 4 "types" of artificial disc being studied and tested. They include composite, hydraulic, elastic and mechanical discs. Total Disc Replacement CHARITÉ Artificial Disc approved for use in the U.S. in October 2004 Aggressively marketed by spine surgeons Charité PDN Prosthetic Disc Nucleus Acroflex Disc Prodisc - L Relatively l new technology and procedure and has a number of unknown risks One major intended benefit of artificial disc replacement (ADR) surgery over spine fusion is that it does not change the biomechanics of the lower spine, allowing the spine to maintain its normal range of motion and thereby reducing or eliminating the risk of degeneration in adjacent segments of the spine Theoretical advantages of the Artificial Disc Designed to mimic the functionality of the patient s own intervertebral disc Prosthesis intended to maintain the normal movement between the vertebral bodies and prevent them from collapsing (and thereby irritating or damaging the nerve root) by maintaining the disc space height between the bones Main theoretical advantage preserve mobility of adjacent discs and delay the onset of arthritic changes adjacent to a fused level Theoretical disadvantages of the Artificial Disc Disc is a very complicated structure, therefore considerable engineering challenge to partially or fully replace a disc Because disc injury is a common cause of back pain in younger adults (age 30 to 50), an artificial disc needs to be designed to last for decades Because of nearby vascular structures and scar tissue from original surgery, revision procedures for a lumbar artificial disc can be very dangerous Outcome of surgery relies on the accurate or precise diagnosis of the source of pain rarely possible in chronic non-specific low back pain There are also psychological, physical, and social factors involved in the successful treatment of chronic pain copied without permission 3
Consensus opinion on indications for TDR Diagnosis of degenerative disc disease or post-laminectomy syndrome at either L4-L5 or L5-S1 levels of the lumbar spine Aged 18 60 Low back pain as the major complaint (rather than leg pain) Not responded to a minimum of 6 months conservative treatment (nonsurgical care, such as physical therapy, pain medications, etc.) Are a candidate for spine surgery (such as a lumbar fusion) Have only one level disc disease (either L5-S1 or L4-L5) Long-term clinical results, radiographic results, and incidence of complications in a large patient cohort with one-level lumbar total disc replacement (TDR) 6 108 patients (mean age of 36.4 years) underwent lumbar TDR with the CHARITE Artificial Disc 106 follow-up Mean follow-up time 13.2 years (10-16.8 years) 87 (82.1%) excellent or good clinical outcome 86/96 returned to work (89.6%) Mean ROM in flexion-extension 10.1 degrees, lateral bending 4.4 degrees (90.6% of implanted prostheses were still mobile) 8 (7.5%) required posterior instrumented fusion 5 cases (4.6%) of postoperative facet arthrosis 3 cases (2.8%) of subsidence 3 cases (2.8%) of adjacent-level disease 2 cases (1.9%) of core subluxation 2006 Systematic review 7 2 RCTs, 2 previous systematic reviews, 7 prospective cohort studies, 11 retrospective cohort studies and 8 case series For DDD at L4/5 or L5/S1, both the clinical outcome and the incidence of major neurological complications following insertion of the Charite artificial i disc were found to be equivalent to those observed following a single level ALIF 2 years following surgery Only 57% of patients undergoing ADR and 46% of patients undergoing fusion met the four criteria listed for success To date, no study has shown total disc replacement to be superior to spinal fusion in terms of clinical outcome long-term benefits of total disc replacement in preventing adjacent level disc degeneration have yet to be realised Negative selection study 8 75 patients with persistent leg and back pain after insertion of an artificial disc Complications subsidence, wear, adjacent disc degeneration, facet joint degeneration and migration 15 posterior fusion without disc removal 22 removed prostheses and performed a posterior and anterior fusion Negative selection study 8 VAS and ODI pre and post revision surgery ODI Scores (1 yr follow up) Post Fusion only (n = 10) Removal prosthesis and 360 fusion (n = 14) Pre-op 57.0 (SD 17.0) 56.3 (SD 14.0) Post-op 44.6 (SD 20.4) 43.0 (SD 20.7) Removal of the disc prosthesis gave slightly better results than posterior fusion alone after a follow-up of at least 1 year Total lumbar disc replacement: different results for different levels 9 level and the number of lumbar disc replacements influence postoperative outcome significantly Good outcomes single segment L4-L5 and L5-S1 disc replacement procedures with best results achieved following TDR at L4-L5 Bi-segmental TDR complication rates significantly higher and inferior postoperative results Post-op pain from posterior joint structures: 9.1% (n = 2) for L4-L5 TDR 28.1% (n = 16) following L5-S1 60.0% (n = 12) for bi-segmental-tdr at L4-L5 + L5-S1 copied without permission 4
Disc Replacement & PT TDR Post-Op Rehabilitation After disc replacement surgery, it has been reported in the European experience and in the U.S. clinical trials that patients can typically expect: Return to daily function soon after surgery, usually without the need for prolonged postoperative bracing Rehabilitation usually starts about four days after surgery No research Similar guidelines as fusion Surgeons are ordering spinal stabilization exercises Avoid extension exercises (ALL disrupted) Hospital stay of about 1 to 4 days Unlike spinal fusion, bone graft is not used so there is no potential for pain or discomfort from the bone donor site Evidence-based Rehabilitation An evidence-based approach Artificial disc replacement surgery is only indicated for a select group of subjects Increasing numbers of spine surgeons and surgery options increase supply. Is there a concerted effort to increase demand? Physical Therapists tend to see the failures rather than the successes Post-Op rehab involves addressing the common complications (failures) Pain Disability/Function ROM Psychological General Health Neurological Motor control/muscles Use appropriate outcome measures Oswestry Disability Index Roland-Morris Questionnaire FABQ Baseline measures and at regular follow ups Focus on functional impairments Emphasize self-management and return to normal activities Patient education, education, education. Managing Pain and ROM Modalities Pain science education Manual Therapy Motor Control for Stability/ Mobility Segmental Stabilization Training (SST) Initial focus on deep corset contraction (DCC) Progression of DCC to weightbearing closed-chain environment Progression to functional activities Leave the open-chain activities until last! copied without permission 5
Case Study 50 yr old male w/ recurrent LBP 7 weeks status post endoscopic nucleoplasty (Dascor Dynadisc) Oswestry 56% NPRS 3/10 Intermittent daily pain Significant difficulty with bending forward, prolonged standing, prolonged sitting, rising from sitting, and walking Dascor curable polyurethane nucleus replacement Evacuation of the degenerative nucleus Balloon emptied of fluid and prepared for injection of polymer Annulus of the disc left intact Final polymer injected into polyurethane bladder Polyurethane balloon inserted and fluid volume calculated Disc height corrected DCC Local Segmental Control DCC Seated and weightbearing DCC Closed chain exercises DCC Closed chain exercises copied without permission 6
DCC Closed chain exercises Case Study Outcome 9 PT visits Oswestry 4% NPRS 0/10 ROM within normal limits Returned to full duties as A/C technician One year follow up Oswestry 0%, NPRS 0/10, no symptoms, back to normal References References 1. http://www.cms.hhs.gov (Accessed 5/14/2008) 2. Cherkin DC, Deyo RA, Loeser JD, Bush T, Waddell G. An international comparison of back surgery rates. Spine 1994 Jun 1;19(11):1201-6 3. Weinstein JN, Lurie JD, Olson PR, Bronner KK, Fisher ES. United States' trends and regional variations in lumbar spine surgery: 1992-2003. Spine. 2006 Nov 1;31(23):2707-14 4. Deyo RA, Nachemson A, Mirza SK. Spinal-fusion surgery - the case for restraint. N Engl J Med 350 (7): 722-6, 2004. 5. Mitchell JM Utilization changes following market entry by physician-owned specialty hospitals. Med Care Res Rev 64 (4): 395-415, 2007. 6. David T. Long-term results of one-level lumbar arthroplasty: minimum 10-year follow-up of the CHARITE artificial disc in 106 patients. Spine 32 (6): 661-6, 2007. 7. Freeman BJ, Davenport J. Total disc replacement in the lumbar spine: a systematic review of the literature. Eur Spine J 15 Suppl 3: S439-47, 2006. 8. Punt IM, Visser VM, van Rhijn LW, Kurtz SM, Antonis J, Schurink GW, van Ooij A. Complications and reoperations of the SB Charite lumbar disc prosthesis: experience in 75 patients. Eur Spine J 17 (1): 36-43, 2008. 9. Siepe CJ, Mayer HM, Heinz-Leisenheimer M, Korge A. Total lumbar disc replacement: different results for different levels. Spine 32 (7): 782-90, 2007. copied without permission 7