compression fractures welcome unc 椎体压缩性骨折欢迎北课件

Vertebral Compression Fractures What should we be doing? (or not doing .) Debra L. Bynum, MD Division of Geriatric Medicine University of North Carolina n“ I firmly believe that if the whole materia medica as now used, could be sunk to the bottom of the sea, it would be all the better for mankind, - and all the worse for the fishes” nOliver Wendell Holmes, address to the Massachusetts Medical Society, 1860 Objectives nUnderstand the theory and basic procedure involved in kyphoplasty and vertebroplasty nBe able to weigh the risks and benefits associated with these procedures nIdentify key management strategies in patients with compression fractures Case nAn 89 year old woman with HTN, mild cognitive impairment, and osteoporosis is admitted with 2 weeks of back pain and is found to have a new thoracic compression fracture. nHer daughter is a cardiologist at Duke and is interested in pursuing possible vertebroplasty. From one website n“A new therapy, Percutaneous Vertebroplasty, is very effective in the management of pain caused by vertebral compression fractures. Percutaneous vertebroplasty can result in relief of pain in 80-90% of patients. The relief is usually achieved within 3 days of the procedure. For more information about this advanced procedure, speak to your pain management physician” The case nYou ask a colleague about vertebroplasty, and you are told A nonblind but randomized study in March showed benefit, but two recent blinded, randomized controlled studies showed no benefit He recommends “shared decision making” talk to the daughter and let her decide Background: Vertebral Compression Fractures nOver 700,000 /year in U.S. n80% prevalence in women over age 80 nComplications: Acute pain and chronic pain Pulmonary dysfunction Loss of mobility Chronic spinal deformity Depression ?increased mortality (marker of frailty) Costly: $ 14 billion/year Background:Vertebroplasty nVertebroplasty (VP) introduced in France in 1984 by interventional neuroradiologist nVP used in US in 1993 n1997: First case series of VP in U.S. Kyphoplasty nAttempt to restore vertebral body height and reduce kyphosis by using inflatable balloon tamp nOrthopedic surgery 1998 nHeight restoration (may be only 3-4 mm) nMore expensive, often with general anesthesia nLess risk of cement leak Background Data (prior to recent studies of controversy) nMultiple small studies of VP demonstrating greater pain reduction, less analgesic use, and greater mobility compared to medical management (initially and at few months) n3 meta-analyses show reduction in pain nMinimal complications Background (cont) nKP with similar history: multiple small studies demonstrating benefit with quicker reduction in pain and mobilization compared to medical treatment nKP and VP: no studies clearly demonstrated any benefit 1-2 years later when compared to medical treatment nProcedures have increased exponentially Cement material previously FDA approved No FDA oversight for new procedures KP vs VP: Which is better? nKP: goal to restore height/reduce kyphosis, but may only increase by 2-4 mm (no sig difference with VP) nKP with less cement leak (1d/14d) 58%23%4%64%42%8% Combo analgesic 58%41%24%56%57%29% Opioid 16%5%4%12%8%5% FREE: problems nExcluded patients with dementia nNot blinded (patients and radiologists) nFunded by Medtronic Spine n12 months: 38 (33%) in KP group and 24 (25%) had new/worsening VCF (p=.22) Take Home (at the time) nDespite the problems, a well designed trial nAlthough no significant difference at 12 months nReduction in short term bedrest and need for opioid analgesics that may be significant in this population nRecommended as possible benefit to select patients New information nNEJM August, 2009 Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures n131 patients with 1-3 painful osteoporotic vertebral compression fractures nVertebroplasty vs simulated procedure nPrimary outcome: Disability Questionnaire (higher score=greater disability) and patients rating of pain RCT n1 month: no significant difference in RDQ score or pain rating (trend toward improved pain in 64 % VP group vs 48 % control, p =.06) nBoth groups had immediate improvement in disability and pain scores Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures nDouble blind, placebo controlled, RCT nPatients with 1-2 painful osteoporotic vertebral fractures less than 12 months and “unhealed” on MRI nPrimary outcome: Pain at 3 months n78 patients, 71 completed 6 month follow up Results nNo difference between groups nBoth had significant reduction in pain at 1 week, 1 month, 3 months, and 6 months n3 months (2.6 points in VP group, 1.9 in control group) nSimilar improvements in both groups with physical functioning, QOL, and perceived improvement Why the difference? The RCT as Gold Standard n1753: naval surgeon James Lind publishes account of comparative treatment of 12 scurvy patients: “their cases as similar as I could have them the most sudden and visible good effects were perceived from the use of the oranges and lemons” The RCT n1930: Sollman suggests approach to problem of investigator bias: use of blinded observer and a placebo control n1932-1937: Harry Gold at Cornell refines the double blind method and use of placebo n1935: Ronald Fishers “The Design of Experiments” argues for use of strictly randomized allocation The RCT nRandomization made test groups more comparable and “ethical” n1947: limited supply of streptomycin for British patients, Bradford Hill in the BMJ pushed for studies with a randomized design: “precluded the biases introduced by our personal idiosyncracies, consciously or unconsciusly applied, or lack of judgment” RCT n1960s: increase value on statistical evidence in interpreting evidence n1990s: Evidence Based Medicine Wont get fooled again nHip protectors and decreased hip fractures nEstrogen use in postmenopausal women decreases the risk of CAD (women on estrogens live 1.5 years longer than those not) nEarly coronary intervention must be good for patients with diabetes and evidence for significant but asymptomatic coronary disease on angiography nMaybe trephination. Problems with prior studies looking at VP and KP nNot blinded Bias on part of investigators (evidence that it“works”) Bias of participants (advertised “evidence” that this works) nUnderestimated placebo effect nEmphasis on “bioplausibility” (like HRT studies) nFavorable natural history of this disease nConfounders that no math can control for (HERS study) Are the results really different? nAlthough not “significant”, some suggestion that pain is decreased at 1 month (similar to FREE study) Care with “not significant” as studies may not have the power to see a difference Although effect likely to be small Are we assuming too much that KP and VP are similar in effect? Concerns about the Validity of most recently reported studies nOutpatients (inpatients may have more severe pain) nPatients received 4 weeks of medical treatment patients on average had 9-16 weeks of symptoms in the 2 recent VP studies (compared to 6 weeks for the Lancet KP study) nCounter: no difference in subgroup analysis between patients with less than or more than 6 weeks of symptoms Take Home nVP likely not much better than conservative treatment, pain control, PT nTime will heal nUnclear what to do with KP, although likely similar nVP and KP not without risk Other Treatments Calcitonin for pain: Fact or Lore? nSystematic review, only 5 decent randomized, controlled studies nReduced pain, immobility, analgesic use nMay help, take with a grain of salt Calcium and Vitamin D nEvidence that Ca and Vitamin D reduce fractures n1200 mg/day Calcium Vitamin D nMounting evidence that deficiency is pandemic nRisk factors: darker skin, obesity, older age, institutionalization nReceptors in every organ nRelationship with sarcopenia and wasting nRelationship to falls Vitamin D refresher nD2 Ergocalciferol Plants, dietary nD3 Cholecalciferol Sun exposure (UVB) and animal (salmon, cod liver) nMetabolized 25 (OH) D in liver 1,25 (OH) D in kidneys Vitamin D: deficiency n25 (OH) D levels n 30: not deficient nMany need supplementation Cannot recommend increase sun exposure Difficult to get enough in diet Vitamin D: replacement n400 IU with MVI nDaily recommendations for those at risk: 800- 1000 IU nReplacement: 50,000 IU /week for 4-6 weeks, recheck Many will need to continue 50,000 /month Other Treatment options nBraces Poor adherence If cord compromise/retropulsion, may need shell Less restrictive: Jewitt May reduce pain by decreasing postural flexion Jewitt Brace Treating Osteoporosis nAntiresorptive agents Block osteoclastic activity Bisphosphonates Estrogen/hormone therapy Raloxifene Calcitonin nAnabolic agents Stimulation of osteoblastic activity Teriparatide (recombinant PTH) Treating Osteoporosis nDespite evidence that multiple agents decrease future vertebral fractures, few patients evaluated or treated after first fragility fracture. What Next? nHow do we truly evaluate the efficacy of procedures? Health Technology Assessment (HTA) program nWashington state legislature 2006 nGovernment sponsored program using formal methods to conduct critical appraisals of surgical devices and procedures, medical equipment, and diagnostic tests nFDA: low standards for devices, and surgical procedures not regulated HTA nPediatric bariatric surgery nLumbar fusion nCT colonography nArthroscopy for OA of knee nCoronary CT angiography Obstacles nIndustry pressure (pressure put on Medicare to cover )