Kyphoplasty In Acute Kyphoplasty In Acute Osteoporotic Osteoporotic

Dorsolumbar FracturesDorsolumbar Fractures

ByBy

Elsayed MahgoubElsayed Mahgoub

SupervisorsSupervisors

Prof. Dr. Hassan Mustafa ElgamalProf. Dr. Hassan Mustafa Elgamal Prof. Dr. Wael Mohammed Tawfiek Prof. Dr. Wael Mohammed Tawfiek

KobtanKobtan Dr. Mohamed Ayman ElroubyDr. Mohamed Ayman Elrouby

(2014)(2014)

First, I would like to express my deepest thanks to "ALLAH", First, I would like to express my deepest thanks to "ALLAH", the most merciful. This would not be achieved without the most merciful. This would not be achieved without "ALLAH" willing and support."ALLAH" willing and support.

I would like to express my deep appreciation and gratitude I would like to express my deep appreciation and gratitude to Prof. Dr.to Prof. Dr. Hassan Mustafa Elgamal, Hassan Mustafa Elgamal, Professor of Professor of Orthopedics Surgery, Faculty of Medicine, Cairo University.Orthopedics Surgery, Faculty of Medicine, Cairo University.

I would like to welcome and thank Prof. Dr.I would like to welcome and thank Prof. Dr. Mohamed Mohamed wafa,wafa, Professor of Orthopaedic Surgery, Faculty of Professor of Orthopaedic Surgery, Faculty of Medicine, Ain Shams University. Medicine, Ain Shams University.

I would like to express my deep appreciation and gratitude I would like to express my deep appreciation and gratitude to Prof. Dr.to Prof. Dr. Hazem Elsebaey, Hazem Elsebaey, Professor of Orthopaedic Professor of Orthopaedic Surgery, Faculty of Medicine, Cairo University,Surgery, Faculty of Medicine, Cairo University,

Purpose of this study: -Purpose of this study: -

To study the role of kyphoplasty in To study the role of kyphoplasty in management of osteoporotic dorsolumbar management of osteoporotic dorsolumbar fractures, analyzing the clinical and fractures, analyzing the clinical and radiographic outcomes. We will evaluate the radiographic outcomes. We will evaluate the efficacy and safety of kyphoplasty for the efficacy and safety of kyphoplasty for the treatment of acute vertebral osteoporotic treatment of acute vertebral osteoporotic compression fractures, to test the hypothesis compression fractures, to test the hypothesis that kyphoplasty will result in diminishing that kyphoplasty will result in diminishing Pain, disability and improving the quality of Pain, disability and improving the quality of life.life.

Vertebral Compression Vertebral Compression FracturesFractures The most common complication of osteoporosisThe most common complication of osteoporosis

The National Osteoporosis Foundation has The National Osteoporosis Foundation has estimated that more than 100 million people estimated that more than 100 million people worldwide are at a risk for the development of worldwide are at a risk for the development of fractures secondary to osteoporosis.fractures secondary to osteoporosis.

Can result in spinal deformity: kyphosis/lordosisCan result in spinal deformity: kyphosis/lordosis

Cause acute and chronic pain leading to disabilityCause acute and chronic pain leading to disability

Cause of reduced vital capacityCause of reduced vital capacity

ComplicationsComplications

OsteoporosisOsteoporosis VCFsVCFs Spinal DeformitySpinal Deformity Decreased lung Decreased lung

capacitycapacity Decreased physical Decreased physical

functionfunction Early SatietyEarly Satiety

Sleep problemsSleep problems Decreased activityDecreased activity More bone lossMore bone loss Increased fracture Increased fracture

riskrisk Decreased Decreased

pulmonary functionpulmonary function Increased mortalityIncreased mortality

PreventionPrevention Bone Density Testing in women > 65 Bone Density Testing in women > 65

years, men > 70 yearsyears, men > 70 years

Adequate intake of calcium, vitamin D, Adequate intake of calcium, vitamin D, and regular weight bearing exerciseand regular weight bearing exercise

Pharmacology: e.g.(bisphosphonates and Pharmacology: e.g.(bisphosphonates and calcitonin).calcitonin).

Reduce the risk of fallingReduce the risk of falling

Signs and SymptomsSigns and Symptoms

Consider VCF in any patient > 50 years if Consider VCF in any patient > 50 years if they complain of acute or chronic back painthey complain of acute or chronic back pain

Get AP and lateral x-ray of the spineGet AP and lateral x-ray of the spine

Look for wedge shaped vertebral bodiesLook for wedge shaped vertebral bodies

MRI with T2 sequence shows state of MRI with T2 sequence shows state of fracture healingfracture healing

Compression fracture in L2 (white arrow).

Tc-99m–bone scan image, posteriorTc-99m–bone scan image, posterior view, demonstrating increased view, demonstrating increased uptake uptake

at the level of a sub acute L2 at the level of a sub acute L2 VCF VCF

(White Arrow)(White Arrow)

Thin-section axial CT (a) and sagittalThin-section axial CT (a) and sagittal

reformatted CT images(b) demonstratingreformatted CT images(b) demonstrating

severe compression fracture of T12 severe compression fracture of T12

(a) (Sagittal T1-weighted MR image) demonstrating VCFs at (a) (Sagittal T1-weighted MR image) demonstrating VCFs at T9, T11, T12, and L1. The acutely compressed T9 and T11 T9, T11, T12, and L1. The acutely compressed T9 and T11 vertebrae demonstrate hypointense marrow signal. Old vertebrae demonstrate hypointense marrow signal. Old fractures of T12 and L1 demonstrate normal marrow signal fractures of T12 and L1 demonstrate normal marrow signal indicating healing). (b) T2-weighted MRI demonstrates indicating healing). (b) T2-weighted MRI demonstrates heterogeneously increased signal in the T9 and T11 heterogeneously increased signal in the T9 and T11 vertebral bodies, and L1 demonstrate normal marrow signal. vertebral bodies, and L1 demonstrate normal marrow signal. (c) Sagittal STIR MR image demonstrates edema in T9 and (c) Sagittal STIR MR image demonstrates edema in T9 and T11.T11.

Conservative TherapyConservative Therapy

NSAIDSNSAIDS Muscle relaxantsMuscle relaxants Bed restBed rest Orthotic bracingOrthotic bracing VCF healing should occur in 6-12 VCF healing should occur in 6-12

weeksweeks

KyphoplastyKyphoplasty

Minimally-invasiveMinimally-invasive PercutaneousPercutaneous Can restore lost vertebral heightCan restore lost vertebral height Immediate pain reductionImmediate pain reduction Fewer complications compared to Fewer complications compared to

vertebroplastyvertebroplasty Kyphoplasty was initially developed in the Kyphoplasty was initially developed in the

late 1990s as a modification of the late 1990s as a modification of the vertebroplasty procedure. vertebroplasty procedure.

Indications for Indications for KyphoplastyKyphoplasty Acute to subacute (usually <3 months old) Acute to subacute (usually <3 months old)

painful vertebral compression fractures painful vertebral compression fractures from osteoporosis, osteolysis or invasion from osteoporosis, osteolysis or invasion of benign or malignant tumorsof benign or malignant tumors

Kyphoplasty is second line approach Kyphoplasty is second line approach considered when the patient has failed considered when the patient has failed standard medical therapy. (after at least 4 standard medical therapy. (after at least 4 weeks).weeks).

However, some operators will intervene However, some operators will intervene more acutely.more acutely.

The contraindication for The contraindication for KyphoplastyKyphoplasty

Absolute contraindicationsAbsolute contraindications Asymptomatic vertebral compression Asymptomatic vertebral compression

fracturesfractures Ongoing local or systemic infectionOngoing local or systemic infection Uncorrectable coagulopathy the goal INR Uncorrectable coagulopathy the goal INR

should be ≤1.4 and the platelet count should be ≤1.4 and the platelet count should be ≥50,000. should be ≥50,000.

Improving pain on medical therapyImproving pain on medical therapy Fractures of the posterior elements (without Fractures of the posterior elements (without

vertebral body fracture)vertebral body fracture)..

Relative contraindicationsRelative contraindications

Retropulsed osseous fragment or Retropulsed osseous fragment or intracanalicular tumor extension with greater intracanalicular tumor extension with greater than one-third spinal canal.than one-third spinal canal.

Burst fractures compromise (high incidence Burst fractures compromise (high incidence of cement leakage).of cement leakage).

Malignant osteolytic lesions with posterior Malignant osteolytic lesions with posterior cortical destruction. cortical destruction.

Loss of greater than two thirds of the Loss of greater than two thirds of the vertebral body height increases the technical vertebral body height increases the technical difficulty of kyphoplasty.difficulty of kyphoplasty.

ComplicationsComplications Nontarget PMMA EmbolizationNontarget PMMA Embolization Intradiscal cement leakage.(increase Intradiscal cement leakage.(increase

incidence of adjacent level fracture).incidence of adjacent level fracture). Anterior and posterior vertebral body Anterior and posterior vertebral body

margins.margins. Posterior epidural passage of cement.Posterior epidural passage of cement.

(Intradural cement leakage has been rarely (Intradural cement leakage has been rarely reported). reported).

Cement extravasation is usually Cement extravasation is usually asymptomatic (96% of vertebroplasty and asymptomatic (96% of vertebroplasty and 89% of kyphoplasty cases) 89% of kyphoplasty cases)

Embolization of PMMA material into Embolization of PMMA material into paraspinal veins(common in vertebroplasty).paraspinal veins(common in vertebroplasty).

Adjacent Vertebral Body or Rib Adjacent Vertebral Body or Rib Fractures.Fractures.

InfectionInfection Rupture of the inflatable balloon tamp.Rupture of the inflatable balloon tamp. Noncement pulmonary emboli are rare Noncement pulmonary emboli are rare

but can be secondary to bone marrow but can be secondary to bone marrow or fat particles displaced from the or fat particles displaced from the vertebral body into the venous vertebral body into the venous circulation.circulation.

There is also a small risk of epidural There is also a small risk of epidural hematoma with both vertebral hematoma with both vertebral augmentation procedure.augmentation procedure.

Materials & MethodsMaterials & Methods

We performed a prospective analysis We performed a prospective analysis of 30 patients treated with of 30 patients treated with Kyphoplasty. They had VCFs at levels Kyphoplasty. They had VCFs at levels T7 to L4 due to osteoporosis arising T7 to L4 due to osteoporosis arising from primary and secondary from primary and secondary osteoporosis. There were 41 VCFs in osteoporosis. There were 41 VCFs in these 30 patients. these 30 patients.

Radiographic Radiographic evaluation:-evaluation:- Standing films were used to measure Standing films were used to measure

kyphosis of the fracture vertebral body. In kyphosis of the fracture vertebral body. In some patients, pre-op standing films could some patients, pre-op standing films could not be obtained due to their pain. In these not be obtained due to their pain. In these cases measurements were taken from the cases measurements were taken from the available supine films. available supine films.

Not all patients underwent magnetic Not all patients underwent magnetic resonance imaging due to financial issues resonance imaging due to financial issues

Computed tomography scans were done as Computed tomography scans were done as a study in patients we thought that they a study in patients we thought that they could have posterior wall fracture. could have posterior wall fracture.

Kyphotic angles across the fractured Kyphotic angles across the fractured level were calculated using the Cobb level were calculated using the Cobb technique.technique.

The operation was considered to be indicated in the The operation was considered to be indicated in the

presence of painful thoracic or lumbar osteoporotic presence of painful thoracic or lumbar osteoporotic fractures without the involvement of the posterior fractures without the involvement of the posterior vertebral edge, classified after the AO classification;vertebral edge, classified after the AO classification;

   A1.1 Endplate impactionA1.1 Endplate impaction A1.2 Wedge impaction fracture A1.2 Wedge impaction fracture A1.3 Vertebral body collapse A1.3 Vertebral body collapse A3.1 Incomplete burst fracture (depending on the A3.1 Incomplete burst fracture (depending on the

degree of the posterior wall involvement)degree of the posterior wall involvement)

Device design:-Device design:-

The kyphoplasty system consists of a balloon, of which one or two each are inserted bilaterally into the vertebral body.

Surgical technique:-Surgical technique:-

A radiolucent table and 2 C-arm A radiolucent table and 2 C-arm fluoroscopy machines Mobile Digital C-fluoroscopy machines Mobile Digital C-Arm were requested for every Arm were requested for every kyphoplasty procedure at our kyphoplasty procedure at our institute. The 2 fluoroscopy machines institute. The 2 fluoroscopy machines placed orthogonally across the placed orthogonally across the radiolucent table allowed radiolucent table allowed simultaneous viewing of simultaneous viewing of anteroposterior and lateral projections anteroposterior and lateral projections of the fractured level.of the fractured level.

General anesthesia was used in 17 General anesthesia was used in 17 procedures and local anesthesia with procedures and local anesthesia with heavy sedation in 13 interventions. heavy sedation in 13 interventions.

The patient was carefully turned prone The patient was carefully turned prone and all bony prominences were protected and all bony prominences were protected to prevent infection, a preoperative single to prevent infection, a preoperative single shot I.V dose of a third generation shot I.V dose of a third generation cephalosporin was administered. cephalosporin was administered.

Two fluoroscopy machines were then Two fluoroscopy machines were then wheeled into position, and the fractured wheeled into position, and the fractured level was centered in both the level was centered in both the anteroposterior and lateral projections. anteroposterior and lateral projections.

ApproachApproach The access instruments can be inserted The access instruments can be inserted

through either a transpedicular or through either a transpedicular or extrapedicular approach. Identify the extrapedicular approach. Identify the anatomical landmarks of the affected anatomical landmarks of the affected segment(s) under imaging. segment(s) under imaging.

Option A: Transpedicular Option A: Transpedicular The incision should facilitate insertion directly The incision should facilitate insertion directly

through the pedicle. Do not breach the through the pedicle. Do not breach the pedicle wall or anterior cortical wall of the pedicle wall or anterior cortical wall of the vertebral body during the approach. vertebral body during the approach.

Option B: Extrapedicular Option B: Extrapedicular The trocar assembly should enter the The trocar assembly should enter the

vertebral body lateral to the pedicle.vertebral body lateral to the pedicle.

Insert the tip of the access Insert the tip of the access

instrumentation through the incision instrumentation through the incision until it contacts the posterolateral until it contacts the posterolateral border of the vertebral body. border of the vertebral body.

Determine access path Determine access path

Access options include trocar or Access options include trocar or guide wire access. The trocar option guide wire access. The trocar option allows access in a single step. The allows access in a single step. The guide wire access can be used to guide wire access can be used to create a path for the access create a path for the access instruments.instruments.

Prepare the inflation systemPrepare the inflation system Attach the stopcock to the inflation system Attach the stopcock to the inflation system Fill the inflation system Fill the inflation system Connect a balloon catheter to the inflation Connect a balloon catheter to the inflation

system and create a vacuumsystem and create a vacuum Inflate Vertebral Body balloons Inflate Vertebral Body balloons

with fluidwith fluid Inflate the balloon, slowly rotate the handle Inflate the balloon, slowly rotate the handle

of the inflation system clockwise while of the inflation system clockwise while monitoring the pressure and volume. Proceed monitoring the pressure and volume. Proceed with inflation slowly, stopping every few with inflation slowly, stopping every few seconds to allow the bone to adjust to the seconds to allow the bone to adjust to the pressure/volume changes. Use fluoroscopy to pressure/volume changes. Use fluoroscopy to monitor balloon inflation. monitor balloon inflation.

Stop increasing pressure when Stop increasing pressure when any of the following happens:any of the following happens:

The desired clinical outcome is The desired clinical outcome is

reached reached The pressure reaches 30 atm (440 The pressure reaches 30 atm (440

psi) psi) The maximum volume is achieved The maximum volume is achieved 4.0 ml for the small balloon 4.0 ml for the small balloon 4.5 ml for the medium balloon 4.5 ml for the medium balloon 5.0 ml for the large balloon 5.0 ml for the large balloon

Deflate and Remove Vertebral Body Deflate and Remove Vertebral Body BalloonsBalloons

Gradually decrease the pressure by turning Gradually decrease the pressure by turning the handle of the inflation system the handle of the inflation system counterclockwise, until the manometer counterclockwise, until the manometer indicates approximately 10 atm (150 psi). indicates approximately 10 atm (150 psi). Slide the wings forward while pulling the Slide the wings forward while pulling the handle all the way back slowly, to fully handle all the way back slowly, to fully collapse the balloon and draw a vacuum. collapse the balloon and draw a vacuum. Release the wings with the handle pulled all Release the wings with the handle pulled all the way back, to seal the vacuum. the way back, to seal the vacuum.

Hold the working sleeves in place and remove Hold the working sleeves in place and remove the catheters to retrieve the balloons.the catheters to retrieve the balloons.

Inject PMMA Bone Inject PMMA Bone CementCement

Under lateral fluoroscopy, inject Under lateral fluoroscopy, inject PMMA cement. The direction of the PMMA cement. The direction of the PMMA flow can be changed by PMMA flow can be changed by orienting the handle of the side-orienting the handle of the side-opening cannula. The arrow on the opening cannula. The arrow on the handle of the side opening needle handle of the side opening needle corresponds to the side of the corresponds to the side of the opening. The PMMA should be opening. The PMMA should be contained within the vertebral body.contained within the vertebral body.

Postoperative scar.

Diagram showing steps of balloon kyphoplasty.

Maximal fracture reduction technique for a patient with L1 vertebral fracture due to osteoporosis.

Clinical Outcome Clinical Outcome measurements:-measurements:- VASVAS Patients were asked to mark their pain on a scale of 0.0 to Patients were asked to mark their pain on a scale of 0.0 to

10.0 cm where 0.0 cm being no pain at all and 10.0 cm is 10.0 cm where 0.0 cm being no pain at all and 10.0 cm is the worst pain imaginable. VAS scores were assessed the worst pain imaginable. VAS scores were assessed before the procedure, and at 1, 4, 12 and 24 weeks after before the procedure, and at 1, 4, 12 and 24 weeks after the procedure.the procedure.

ODIODI The ODI is a low back pain specific questionnaire The ODI is a low back pain specific questionnaire

that assesses the ability of the patient to perform that assesses the ability of the patient to perform various activities of daily living. The ODI has been various activities of daily living. The ODI has been shown to have high test-retest reliability and is shown to have high test-retest reliability and is the most commonly recommended condition-the most commonly recommended condition-specific outcome measure in patients with chronic specific outcome measure in patients with chronic low back pain. low back pain.

SCORE INTERPRETATION OF THE OSWESTRY LBP DISABILITY QUESTIONNAIRE

0-20% Minimal disability

20-40% Moderate disability

40-60% Severe disability

60-80% Crippled Back pain

80-100% These patients are either bed-bound or exaggerating their symptoms. Data compiled from Fairbanks et al, 1980.

Study populationStudy population

A total of 30 patients with 41 VCFs A total of 30 patients with 41 VCFs underwent kyphoplasty at our underwent kyphoplasty at our institution from Feb 2011 to Jun institution from Feb 2011 to Jun 2013. The study population included 2013. The study population included (10) male (33.3%) and (20) female (10) male (33.3%) and (20) female (66.6%). The median age of the (66.6%). The median age of the patients was 69 years (range 53–87 patients was 69 years (range 53–87 years). The follow up period was 24 years). The follow up period was 24 weeks.weeks.

The causes of injury were either simple The causes of injury were either simple fall on the ground in (14) patients(46.7%) fall on the ground in (14) patients(46.7%)

RTA in (6) patients (20%), RTA in (6) patients (20%),

(4) patients(13.3%) gave a history of (4) patients(13.3%) gave a history of lifting heavy object preceding their lifting heavy object preceding their feeling of pain and feeling of pain and

(6) patients (20%) developed sudden (6) patients (20%) developed sudden onset of pain without precipitating onset of pain without precipitating incidentincident

Age of fracturesAge of fractures

15 patients (50%) presented with a 15 patients (50%) presented with a history of fracture of less than 10 history of fracture of less than 10 days whereas (11) patients (36.7%) days whereas (11) patients (36.7%) gave a history of fracture from 10-30 gave a history of fracture from 10-30 days. 2 Patients (6.7%) presented days. 2 Patients (6.7%) presented with a history of fracture from 30-40 with a history of fracture from 30-40 days. Note that in 2 patients (6.7%), days. Note that in 2 patients (6.7%), the exact age of fracture couldn't be the exact age of fracture couldn't be estimated estimated

Level of fractureLevel of fracture

The clinical outcomes:-The clinical outcomes:-

Change in spinal sagittal Change in spinal sagittal alignmentalignment

The median kyphosis angle was 21.8 The median kyphosis angle was 21.8 degrees before the procedure and degrees before the procedure and decreased by a median of 6.7 degrees decreased by a median of 6.7 degrees after the operation. 60% of patients after the operation. 60% of patients experienced a reduction in kyphosis experienced a reduction in kyphosis of more than 5 degrees of more than 5 degrees

Improvement in Spinal Sagittal Alignment

Changes in kyphotic angle

The median VAS scores. went from The median VAS scores. went from 8.7 preoperatively to 3.5 at one week 8.7 preoperatively to 3.5 at one week postoperatively , to 1.7 at 12 weeks postoperatively , to 1.7 at 12 weeks following the procedure and to 1.5 at following the procedure and to 1.5 at 24 weeks and last follow up. 24 weeks and last follow up.

The mean preoperative ODI score The mean preoperative ODI score was 80, decreasing to 32 at 1 month was 80, decreasing to 32 at 1 month post-op, and improving to 21 and 17 post-op, and improving to 21 and 17 at 3-month and last follow- up, at 3-month and last follow- up, respectively.respectively.

The median preoperative ODI score The median preoperative ODI score was 85.00, improving to 32.6 at 1 was 85.00, improving to 32.6 at 1 month postoperatively, and month postoperatively, and decreasing 22 and 18 at 3-month decreasing 22 and 18 at 3-month and last follow-up, respectivelyand last follow-up, respectively

Complications:-Complications:-

Cement leakage:-Cement leakage:-

Location of cement leakage:-Location of cement leakage:-Location of leakage Number Percentage Complications

Adjacent intervertebral disc 3 27% No

Anterior to vertebral body 4 36% No

Lateral to vertebral body 3 27% No

In the spinal canal 1 9% No

Total 11 100% No

Failure of balloon distension:-Failure of balloon distension:- We treated 41 fractures with BKP. We treated 41 fractures with BKP.

Failure of balloon distension occurred Failure of balloon distension occurred in 6 fractures (14%), so we in 6 fractures (14%), so we managed these fractures with managed these fractures with conventional vertebroplastyconventional vertebroplasty

Fracture of bone filler:Fracture of bone filler: We treated 41 fractures with BKP. We treated 41 fractures with BKP.

Fracture of bone filler occurred only Fracture of bone filler occurred only in one patient in one patient

Case presentationCase presentation CASE 1CASE 1 Name: MA Age: 76. Number:1Name: MA Age: 76. Number:1 Age of fracture: 13 days.Age of fracture: 13 days. M.O.I: did not recall specific injury.M.O.I: did not recall specific injury. Medical history of D.M, H.T.N, Old CVA & Medical history of D.M, H.T.N, Old CVA &

Renal impairment. Renal impairment. X-ray: Osteoporotic Compression fractures X-ray: Osteoporotic Compression fractures

T12.T12. Operated with : BKP (T12). But, there was Operated with : BKP (T12). But, there was

cement leakage towards inter vertebral cement leakage towards inter vertebral disc and the patient presented without disc and the patient presented without neurological manifestation.neurological manifestation.

Case 2Case 2 Name: A.H Age: 84 Number: Name: A.H Age: 84 Number:

66 Age of fracture: 3 days.Age of fracture: 3 days. M.O.I.: No obvious cause.M.O.I.: No obvious cause. Medical history of D.M, H.T.N & Medical history of D.M, H.T.N &

Cardiac problems. Cardiac problems. X-ray: Osteoporotic Compression X-ray: Osteoporotic Compression

fractures L2, 3.fractures L2, 3. Operated with : BKP pain improved Operated with : BKP pain improved

after surgery. Patient started assisted after surgery. Patient started assisted weight bearing 48hrs after surgery.weight bearing 48hrs after surgery.

CASE 3CASE 3 Name: M.S Age: 65. Number: Name: M.S Age: 65. Number:

2626 Age of fracture: 10 days.Age of fracture: 10 days. M.O.I: Simple fall on the ground.M.O.I: Simple fall on the ground. Medical history; D.M, HTN.Medical history; D.M, HTN. X-ray: Osteoporotic Compression X-ray: Osteoporotic Compression

fractures L1.fractures L1. Operated with: BKP pain dramatically Operated with: BKP pain dramatically

improved after surgery. Patient improved after surgery. Patient started assisted weight bearing started assisted weight bearing 48hrs after surgery.48hrs after surgery.

DiscussionDiscussion The first experience with the use of The first experience with the use of

kyphoplasty was published by kyphoplasty was published by Wong et Wong et al. al. in the Journal of Women’s Imaging in in the Journal of Women’s Imaging in 2000. They report on the experience of 2000. They report on the experience of

85 patients. Over 90% of patients 85 patients. Over 90% of patients report good or excellent pain relief. The report good or excellent pain relief. The height restoration was 62%. height restoration was 62%. Lieberman Lieberman

et alet al. presents a prospective clinical . presents a prospective clinical investigation the treatment of 30 investigation the treatment of 30

patients with 70 kyphoplasty patients with 70 kyphoplasty procedures performed. Local cement procedures performed. Local cement

leakage was observed in 8.6%leakage was observed in 8.6%

Theodorou et alTheodorou et al. reports on the treatment of . reports on the treatment of 15 patients with 24 BKP. Height restoration 15 patients with 24 BKP. Height restoration was best in the mid- vertebral body with was best in the mid- vertebral body with 65%. Kyphosis correction was 9.5° in 65%. Kyphosis correction was 9.5° in average or by 62%. Pain was improved in all average or by 62%. Pain was improved in all patients at a follow-up of 6– 8 months. patients at a follow-up of 6– 8 months.

Coumans et al. Coumans et al. presents a prospective study presents a prospective study with kyphoplasty with a minimal follow-up of with kyphoplasty with a minimal follow-up of 1 year. Of 78 patients with 188 kyphoplasty 1 year. Of 78 patients with 188 kyphoplasty procedures, 62% were available for a follow-procedures, 62% were available for a follow-up evaluation. They report five cases of up evaluation. They report five cases of asymptomatic extravasation. Oswestry asymptomatic extravasation. Oswestry score and pain (VAS) improved immediately score and pain (VAS) improved immediately postoperatively with lasting effect at FU. postoperatively with lasting effect at FU. The kyphosis correction is not mentioned The kyphosis correction is not mentioned

In our study, we found that the median In our study, we found that the median kyphosis angle was 21.8 degrees before kyphosis angle was 21.8 degrees before the procedure and decreased by a median the procedure and decreased by a median of 6.7 degrees after the operation. 60% of of 6.7 degrees after the operation. 60% of patients experienced a reduction in patients experienced a reduction in kyphosis of more than 5 degrees kyphosis of more than 5 degrees (Interquartile range 10 degrees). In an (Interquartile range 10 degrees). In an analysis of this subgroup of patients, analysis of this subgroup of patients, faster pain relief was achieved compared faster pain relief was achieved compared with patients who showed minimal to no with patients who showed minimal to no reduction in Kyphotic angle. reduction in Kyphotic angle.

The VCFs were then analyzed by spinal The VCFs were then analyzed by spinal region (thoracic or lumbar).region (thoracic or lumbar).

Long-term follow-up will be required to Long-term follow-up will be required to determine whether the improvement in determine whether the improvement in spinal kyphosis will reduce the disability, spinal kyphosis will reduce the disability, morbidity, or risk of subsequent VCFs morbidity, or risk of subsequent VCFs associated with kyphotic deformity from associated with kyphotic deformity from osteoporotic vertebral fractures. The osteoporotic vertebral fractures. The clinical and radiographic results showed clinical and radiographic results showed that the effects of BKP are immediate and that the effects of BKP are immediate and dramatic, and showed no evidence of dramatic, and showed no evidence of deteriorating with time. Alleviation of pain, deteriorating with time. Alleviation of pain, reduction in the use of pain medications, reduction in the use of pain medications, and improved mobility occurred within the and improved mobility occurred within the first few postoperative days to weeks and first few postoperative days to weeks and remained stable for the entire length of remained stable for the entire length of study.study.

Pain relief after BKP was rapid and Pain relief after BKP was rapid and evident within the first week after the evident within the first week after the procedure. The pain relief was sustained procedure. The pain relief was sustained for up to 6 months after the procedure. for up to 6 months after the procedure. The majority of patients also reported a The majority of patients also reported a return to pre-fracture functional levels. return to pre-fracture functional levels. This effect was shown by at least a 4-This effect was shown by at least a 4-point decrease in the VAS pain score and point decrease in the VAS pain score and ODI score.ODI score.

In our study, Evaluation of intraoperative In our study, Evaluation of intraoperative and postoperative radiographs and postoperative radiographs revealed extra vertebral cement leaks in revealed extra vertebral cement leaks in 11 levels (27%) of 41 vertebral fractures 11 levels (27%) of 41 vertebral fractures treated. from our experience, it seems treated. from our experience, it seems that the using of BKP limit the occurrence that the using of BKP limit the occurrence of extravasation. As our results about of extravasation. As our results about extravasation are decreased than those extravasation are decreased than those reported from conventional reported from conventional vertebroplasty.vertebroplasty.

Conclusion:-Conclusion:-

The important thing that has to be in mind is that The important thing that has to be in mind is that the device is expensive an issue that needs to be the device is expensive an issue that needs to be considered in times of cost problems in nearly considered in times of cost problems in nearly every health care system; therefore, the use of every health care system; therefore, the use of these techniques appears restricted to selected these techniques appears restricted to selected cases. The BKP system is designed to treat cases. The BKP system is designed to treat painful vertebral body compression fractures, painful vertebral body compression fractures, ideally after failed period of conservative ideally after failed period of conservative treatment for 4 weeks which includes short treatment for 4 weeks which includes short periods of bed rest, followed by gradual increase periods of bed rest, followed by gradual increase in mobilization, braces, analgesics, narcotics in mobilization, braces, analgesics, narcotics and physical therapy. This failure is manifested and physical therapy. This failure is manifested by progressive increase in deformity and by progressive increase in deformity and persistent of the same pain intensity.persistent of the same pain intensity.

Thank You!Thank You!