osteoporotic fractures - pennsylvania brain & spine...
TRANSCRIPT
Kyphoplastyyp p y
Richard M. Spiro, MDp ,Michael Horowitz, MD
Painf lPainful OsteoporoticOsteoporotic Compression Co p ess o
Fractures
Treatment Objectives & OptionsTreatment Objectives & Options
Orthopedic Fracture Care
Why have we been contentWhy have we been content to leave the spine in a
physiologically and biomechanically compromised condition?compromised condition?
VCF Treatment Objectives
R i f Restoration of anatomy Early diagnosis and treatment for optimal 1
outcomes Special care for geriatric patientsp g p
–frail physical status and comorbidities
1 Colton, CL. Ch. 1 in Skeletal Trauma. 19982 Brakoniecki et al. Ch. 7 in Skeletal Trauma. 1998
VCF Treatment OptionsManagement for Pain
M di l M
Management for Pain
Medical ManagementBed rest Narcotic analgesicsNarcotic analgesics Braces
Open Surgical Treatment
Vertebroplasty
Balloon KyphoplastyO i f T t t StOverview of Treatment Steps
1) Th b ll i i d i h f d b l b d1) The balloon is inserted into the fractured vertebral body
Balloon Kyphoplasty O i f T t t StOverview of Treatment Steps
2) h b ll fl d d h f d l h d l2) The balloon is inflated, reducing the fracture and elevating the endplates
Balloon Kyphoplasty Overview of Treatment StepsOverview of Treatment Steps
3) The balloon is deflated and withdrawn, leaving a cavity within the vertebra
Balloon KyphoplastyOverview of Treatment StepsOverview of Treatment Steps
4) The void is filled with KyphX® HV-R™ Bone Cement, creating an “internal cast”
Case StudyPatient: 73 YO FemaleDiagnosis: Primary OsteoporosisFracture Reduced: L1 6 months oldFracture Reduced: L1, 6 months old
Courtesy of Mohammad Majd, M.D., Jeffersonville, IN
Case StudyCase StudyPatient: 55 YO MaleDiagnosis: Secondary osteoporosisFracture Reduced: L-1, 3 day old
f l h lCourtesy of Ulrich Berlemann, M.D., Germany
Patient Selection d kand Work-Up
DiagnosisDiagnosis
Identify painful levelIdentify painful levelDefine fracture configuration
Define fracture age
Osteoporotic Fracture?
History and Physical ExamHistory and Physical Exam
Has there been a recent event, prior to onset of pain?
Does direct pressure on suspect vertebral bodies elicit pain?
Pain findings on physical exam should be concordant with radiographic findings.g p g
Some patients will have multiple painful vertebral bodiesbodies.
X-Rayy
Older films (if available) may be useful to assess fracture
progression
Case StudyCase StudyPatient: 80 YO MaleDiagnosis: Steroid-induced osteoporosisFracture Reduced: T-8, 10 weeks old
Courtesy of Eeric Truumees, M.D., Southfield, MI
Case StudyCase StudyPatient: 75 YO FemaleDiagnosis: Primary osteoporosisFracture Reduced: L-3, 4 week old
Courtesy of Jonathan Hyde, M.D., Miami Beach, FL
MRI T1 weighted shows high intensity for fat,
b t h t d G d li isubacute hematomas and Gadolinium enhanced substances T eighted sho s high intensit for T2 weighted shows high intensity for
conditions that increase free water, such as acute fractureacute fracture STIR MRI sequence is most sensitive for
water content when assessing fractureswater content when assessing fractures
MRINotice the high signal intensity around the fracture
T2T1
CT and Bone ScanCT and Bone Scan CT Scan
Diff ti t f t f th ft ti–Differentiates fat from other soft tissue–Shows structure of bone –Extremely high contrast between calcified structures (cortical and trabecular bone) and soft tissueEffectively limited to axial plane–Effectively limited to axial plane
Use CT plus Bone Scan to determine fracture when MRI cannot be used–Implantable metal devices
Balloon KyphoplastyBalloon KyphoplastySurgical Approaches and
Technique
Balloon Kyphoplasty Approaches
Transpedicular Extrapedicular
yp p y pp
p p
Both approaches are intended to be bilateral
TRANSPEDICULAR APPROACH AccessAccess
Use fluoroscopy to locate the pedicle oca e e ped c ecutaneously
Place a small incision lateral and superior tolateral and superior to the cutaneous pedicle locationThi ill ll This will allow proper convergence through the tissues to the pedicle entry pointpedicle entry point
TRANSPEDICULAR APPROACH Inflatable Bone Tamp InflationInflatable Bone Tamp Inflation
Place contralateral tools and IBTtools and IBT
Increase the volume in both IBTs in small (0.25-0.5 cc) incrementsA t i d Assess tamp size and position in lateral and AP views
Sequentially inflate until an inflation
d i i h dendpoint is reached
VCF TreatmentCementingCementing
Deflate and remove IBTs
Insert BFD to within 3-5mm of anterior cortex5mm of anterior cortex
Under continuous fluoroscopy slowly inject the cement mix
Leave the bone void filler device anterior
VCF Treatment Cementing APCementing AP
Final A-P view of cement fill
Cement fills in interstices of fractured boneof fractured bone
Balloon Kyphoplasty ExperienceExperience
Balloon Kyphoplastyyp p y
Since 1998Approximately 95,000 fractures
have been treated worldwidehave been treated worldwide
Patient OutcomesPatient Outcomes
Correction of Vertebral Body DeformityR d ti i P i Reduction in Pain Improvement in Quality of Life Improvement in Ability to Perform
Activities of Daily Livingy g High rates of Patient Satisfaction Low Complication Rate Low Complication Rate
Percent Lost Height Restoredg
Based on the mean height measurement of the closestmeasurement of the closest, unfractured vertebrae above and below the treated leveland below the treated level
A i idli d i Anterior, midline, and sometimes posterior measurements are taken
Example: Percent Lost Height Restoredp g
20 mm 24 mmAvg. 30 mm
% L t H i ht R t d% Lost Height Restored = (24 – 20) / (30 - 20) or 4/10 = 40%40%
Vertebral Body Height RestorationPercent of Lost Vertebral Body Height RestoredPercent of Lost Vertebral Body Height Restored
In a U.S. Multicenter, Prospective Single Arm Study– 65 patients treated – 30.2% of the average lost65 patients treated 30.2% of the average lost
midline height was restored for all fractures– Among reducible fx’s*, ( 78% of all fx’s), an g , ( ),
average of 58% of lost midline height was restored– Mean fracture age was 4.3 monthsg– No evidence of loss of improvement at two year
follow-up
Kyphon U.S. Study; Data on file at Kyphon Inc.
* “Reducible” refers to measurable fractures where at least 15% of predicted height was lost due to fracture.
Vertebral Body Height RestorationPercent of Lost Vertebral Body Height RestoredPercent of Lost Vertebral Body Height Restored
Lieberman et al (2001) states of 70 fractures treated, average lost midline height restored wastreated, average lost midline height restored was 35%– In the group of fx’s that were reducible g p
(70% of all fx’s treated), lost midline height restored was 47%*
– Mean fracture age was 5.9 months*A reducible fracture is defined by Lieberman as having restored at least 10% of lost vertebral body height at the midline with kyphoplasty.
Lieberman et al. (2001) Spine 26: 2, 1631-1638
Vertebral Body Height RestorationPercent of Lost Vertebral Body Height RestoredPercent of Lost Vertebral Body Height Restored
Theodorou et al (2002) reported that among 24 f l h i h d 52%fractures average lost height restored was 52%– Average lost anterior height restored was 52%– Average lost midline height restored was 66%– Mean fracture age was 3.2 months
Theodorou et al (2002) J Clin Imaging 26:1-5
Significant Pain Reduction
Following Balloon Kyphoplasty, Ledlie, et. al. (2003) Reports the mean pre-operative pain VAS score was 8.6 (96 cases). The post-operative mean VAS scores were 2.7 (89 cases) at 1 week and 1.4 (29) at 1 year follow up(29) at 1 year follow-up
I t ti l i G fi t l (2001) In a retrospective analysis, Garfin, et. al. (2001) reported “most patients have gone from narcotic analgesics to over the counter medication”analgesics to over the counter medication
1. Garfin SR (2001), 2. Ledlie J (2003)
Significant Pain Reductiong Multi-center prospective single-arm U.S. study
A f 60% d ti i i
1
– Average of 60% reduction in pain– Pre-operative VAS score = 7.5, one-week post-op follow-up VAS = 3 (p<0.01)– Results persisted for two years. (n=100)
Ledlie et al (2002) reported similar results pain reduction was noted at oneLedlie et al. (2002) reported similar results, pain reduction was noted at one week follow-up, with a continuation in improvement at one year 2
1. Kyphon U.S. Study, Data on file at Kyphon Inc. 2. Ledlie et al. (2003) J Neurosurg (Spine 1) 98: 36-42
Improvement in Quality of Life Coumans et al (2003) report on 78 patients and 188 procedures,
Patient quality of life is reflected by marked improvement in seven measures of SF-36 scores
Black bar= pre-opGray bar =post-op
Higher score indicates better performancePF= Physical Functioning, V= Vitality, RF=Role Functioning, SF= Social Functioning
Coumans et al. (2003) J Neurosurg (Spine 1) 99:44-50
BP= Bodily Pain, RE= Role Emotional, GH =General Health, MH=Mental Health
Activities of Daily LivingActivities of Daily Living Ambulatory Status
St di i di t th t b l t t t i i kl i d ft B ll–Studies indicate that ambulatory status is quickly improved after Balloon Kyphoplasty and persists at one year
–In a retrospective analysis following 79 patients treated (Ledlie et al), 80% f ll ti t f ll b l t t k f ll d 27 f th•80% of all patients fully ambulatory at one week follow-up and 27 of the
patients followed for one year maintained full ambulatory status •90% of patients (10 out of 12) who were wheelchair-bound preoperatively were ambulatory at one week follow-up
Ledlie et al. (2003) J Neurosurg (Spine 1) 98: 36-42
Improved Activities of Daily LivingF tiFunction
Coumans et al report 15% improvement in function as shown by O t Di bilit I d (ODI)Oswestry Disability Index (ODI)
• Measurements in the early post-operative period and continuing through long term follow-up (12-18 month f/u)
Coumans et al. (2003) J Neurosurg (Spine 1) 99:44-50
Improved Activities of Daily LivingF tiFunction
A multicenter prospective single arm U S study measured back function A multicenter, prospective single-arm U.S. study measured back function– Evaluated the ability to bend forward, lift 10 pounds and
stand for one hour both pre and post-operatively – Significant improvement was noted at one month and
persisted at two- year follow-up in all three areas
Kyphon U.S. Study, Data on file at Kyphon Inc.
Patient SatisfactionPatient Satisfaction
In a prospective U.S. study, patients were asked to rate their level of satisfaction with the outcome of their k h l t dkyphoplasty procedure – Scale of 1-20
• 1 = “completely dissatisfied”20 “ l t l ti fi d”• 20 = completely satisfied
The mean score at one week post-operative was 17.5 and persisted throughout two year follow-up (n=100 patients)
Kyphon U.S. Study, Data on file at Kyphon Inc.
Low Complication RateLow Complication Rate
In a literature review of 1342 vertebrae treated withIn a literature review of 1342 vertebrae treated with balloon kyphoplasty– Total adverse events are 1% per fracture (2% per patient)
Bone cement leaks associated with injury are < 0 2% per fracture– Bone cement leaks associated with injury are < 0.2% per fracture (<0.3% per patient)
Balloon kyphoplasty can compact cancellous bone and Balloon kyphoplasty can compact cancellous bone and create a cavity
The low complication rate is also related to the way in which viscous bone cement is delivered into the cavity under fine manual control
ConclusionsConclusions
Kyphoplasty is a safe and effective treatment for osteoporotic compression fractures Safe and effective for pathological fractures p g Usually 1 night stay in hospital and can be
done as outpatientdone as outpatient
Case StudyCase StudyPatient: 61 YO FemaleDiagnosis: Multiple MyelomaFracture Reduced: T11-L2, 1 ½ yrs old
Courtesy of Kent Grewe, M.D., Portland, OR
Case StudyCase Study
Patient: 76 YO FemalePatient: 76 YO FemaleDiagnosis: Metastatic Lung CancerFracture Reduced: T8, 8 weeks old
Courtesy of Henry Small, M.D., Houston, TX
Case Studyy
Patient: 80 YO FemaleDiagnosis: Primary OsteoporosisFracture Reduced: L1, 2 months old
Courtesy of James Hazel, M.D., Richland, WA
Case Studyy
Patient: 65 YO FemaleDiagnosis: Primary OsteoporosisFracture Reduced: L2, 9 weeks old
C f Vi L idi M D Philli b NJCourtesy of Vito Loguidice, M.D., Phillipsberg, NJ
Case StudyCase StudyPatient: 61 YO MaleDiagnosis: Multiple MyelomaFracture Reduced: T11, 5 weeks old
C f P l P M D H TXCourtesy of Paul Pagano, M.D., Houston, TX
Case StudyCase StudyPatient: 79 YO FemaleDiagnosis: Primary osteoporosisFracture Reduced: T-11, 7 weeks old
f dCourtesy of James Hamada, M.D., Torrance, CA
Case StudyCase Study
Patient: 61 YO MalePatient: 61 YO MaleDiagnosis: Multiple MyelomaFracture Reduced: T-11, 5 weeks old
Courtesy of Donald Schomer, M.D., Houston, TX
Case StudyCase StudyPatient: 81 YO MaleDiagnosis: Primary osteoporosisFracture Reduced: L-1, 10 days old
f kCourtesy of Bruce Orisek, M.D., Santa Cruz, CA
Case StudyCase StudyPatient: 89 YO FemaleDiagnosis: Primary osteoporosisFracture Reduced: T-7, 1 year old Fx (2 Stage Inflation)
f d llCourtesy of Wade Wong, DO, La Jolla, CA
Literature Review ReferencesLiterature Review References
Boszczyk et al (2004) Microsurgical interlaminary vertebro and kyphoplastyBoszczyk et al. (2004) Microsurgical interlaminary vertebro- and kyphoplasty for severe osteoporotic fractures. J Neurosurg (Spine 1) 100:32-37
Coumans et al (2003) Kyphoplasty for vertebral compression fractures: 1-year clinical outcomes from a prospective study. J Neurosurg (Spine 1) 99:44-50
D dene et al (2002) K phoplast in the treatment of osteol tic ertebralDudeney et al. (2002) Kyphoplasty in the treatment of osteolytic vertebral compression fractures as a result of multiple myeloma. J Clin Oncol 20:2382-2387
Fourney et al. (2003) Percutaneous vertebroplasty and kyphoplasty for painful vertebral body fractures in cancer patients J Neurosurg (Spine 1) 98:21-30vertebral body fractures in cancer patients. J Neurosurg (Spine 1) 98:21-30
Garfin SR, Yuan HA, Reiley MA (2001) Kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures. Spine 26:1511-1515
Komp et al (2004) Minimally invasive therapy for functionally unstableKomp et al. (2004) Minimally invasive therapy for functionally unstable osteoporotic vertebral fracture by means of kyphoplasty: Prospective comparative study of 19 surgically and 17 conservatively treated patients. J Miner Stoffwechs 11 (Suppl 1):13-15
Kyphon U.S. Multicenter Prospective Single Arm Study. Data on file atKyphon U.S. Multicenter Prospective Single Arm Study. Data on file at Kyphon Inc.
Lane et al. (2002) Minimally invasive options for the treatment of osteoporotic vertebral compression fractures. Orthop Clin N Am 33:431-438
Literature Review ReferencesLiterature Review ReferencesLedlie J, Renfroe M (2003) Balloon Kyphoplasty: One Year Outcomes in
Vertebral Body Height Restoration, Chronic Pain, and Activity Levels. J y g , , yNeurosurg (Spine 1) 98: 36-42
Lieberman et al (2001) Initial Outcome and Efficacy of Kyphoplasty in the Treatment of Osteoporotic VCFs. Spine 26: 2, 1631-1638
Lieberman IH, Reinhardt M-K (2003) Vertebroplasty and kyphoplasty for , ( ) p y yp p yosteolytic vertebral collapse. Clin Orthop 415(Suppl):S176-S186
Phillips et al. (2003) Early radiographic and clinical results of balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. Spine 28, 19: 2260-2267
Phillips et al. (2002) An In Vivo Comparison of the Potential for Extravertebral Cement Leak After Vertebroplasty and Kyphoplasty. Spine 27, 19: 2173-2179
Theodorou DJ, Theodorou SJ, Duncan T, Garfin SR, Wong W (2002) Percutaneous Balloon Kyphoplasty for the Correction of Spinal Deformity in yp p y p yPainful Vertebral Compression Fractures. J Clin Imaging 26:1-5
Voggenreiter G, Sadik M, Majetschak M, et al. (2004) Treatment results of the kyphoplasty balloon technique. MedReview:17-18
Wilhelm K, Stoffel M, Ringel F, et al. (2003) Preliminary experience with balloon , , g , ( ) y pkyphoplasty for the treatment of painful osteoporotic compression fractures. Fortschr Rontgenstr 175:1690-1696
Wong W, Reiley MA, Garfin SR (2000) Vertebroplasty / Kyphoplasty. J Women’s Imaging 2(3)