19 Harley St, London, W1G 9QJ, UK

Balloon Kyphoplasty & Vertebroplasty

Mr Mo Akmal
BSc (Hons) MD FRCS(Orth)

Consultant Orthopaedic Spinal Surgeon

Vertebral Compression Fractures
Fragility Fracture
• Definitions of Fragility Fracture;
– Fracture resulting from a low trauma event.
– Fall from a standing height or less

• Diagnosis of Osteoporosis;
– BMD measurement by DEXA on 2 sites preferably Spine and Hip.
– Conventional Xrays and Bone turnover biochemical markers have no role in the diagnosis of OP or in the section of patients for BMD measurement

Osteoporosis Epidemiology – UK
• Prevalence
– 1 in 3 women and 1 in 12 men over age 50

• Osteoporotic fracture every 3 minutes
– 70,000 hip fractures/year
– 50,000 wrist fractures/year
– 120,000 spinal fractures/year

• Costs the NHS and government over £1.7 billion each year (i.e. £5 million each day!)

? 438,750 clinically diagnosed VCFs per year in the EU (117 per 100 000 person years 1 )

Healthcare Implications
• Morbidity following symptomatic vertebral fracture
– 41% with constant pain
– 71% difficulty standing
– 75% early awakening due to pain
– 59% pain on walking

? Spinal deformity and pain impair function, decrease mobility1,2
? Decreased activity leads to more bone loss1
? Decreased appetite, sleep disorders1
? Increased depression, dependence on others3
? Diminished social roles, lower self esteem3

Morbidity
Cost to Society
• Annual incidence 1% patients at age 65 yrs
• 1/3rd clinically significant
• 1/3rd Hospitalised
• Cost £5000 to £7000 per hospitilisation
• Length of stay 6 days
• Cost of Hospital stay 63% of cost for hip fracture
THE HUMAN COST
Increased Pulmonary Disorders
VCF reduces pulmonary function1

? One thoracic VCF causes 9% loss of forced vital capacity 2

? Lung function (FVC, FEV1) is significantly reduced in patients with thoracic and lumbar fracture1
THE HUMAN COST
Downward Spiral
NICE Guidelines
• >75yrs – any fragility fracture alone

• 65-75 – fragility fracture + BMD T<-2.5

• 50-65 – fragility fracture + T <-3 or another risk factor
» Low body mass index (<19 Kg/m2)
» Family History of maternal hip Fracture before the age of 75 yrs
» Untreated premature menopause
» Certain medical disorders independently assoc with bone loss (ie chronic IBD, RA, Coeliac Disease, Hyperthyroidism)
» Conditions assoc with prolonged immobility
Is this a benign process?
“they all heal…..”

Signs of VCF

• Decrease in gait velocity1
• Change in balance1
• Increased muscle fatigue1
• Increased risk of falls and additional fractures1
• Risk of VCF increases 5 fold after first VCF2

• 23% of patients have further fracture within 2yrs

Vertebral Fractures Beget Vertebral Fractures
RR with 1 prevalent deformity = 3
RR with 2 prevalent deformities = 10
RR with 3 prevalent deformities = 23
when compared to patients without baseline deformity
Risk of Subsequent VCF’s
• Wide variation in clinical studies

– 3% future risk (Garfin et al 2001)

– 11% in Primary and 48% in Secondary (steroid induced) osteoporosis (Harrop et al 2004)

– 26% (Fribourg et al 2004)

– Risk of VCF increases 5 fold after first VCF

– 23% of patients have a further fracture within 2 years (Ross et al, Annals Int Med 1991 & Lindsay et al JAMA 2001)

Multicenter Balloon Kyphoplasty Study (FREE) 2 year Outcomes
• 155 Patients 214 fractures
• 85% pain free
• SF-36 and VAS scores significantly better.

• Following the procedure, patients had significant, immediate and sustained improvement in measurements of pain, function, and quality of life.

VCF Treatment
Careful patient assessment
Diagnosis
• Pain when erect posture
• Spinal tenderness
• Deformity
• XRAY
• MRI Scan
• DEXA
• Pain lying on back
• Exclude other pathology !

VCF Treatment Objectives
• Relief of Pain
• Restoration of anatomy1
– Early diagnosis and treatment2

1 Colton, “The History of Fracture Treatment,” Skeletal Trauma, Ch. 1, Vol. 1, Pg. 25, ©1998 W.B. Saunders Company

2 Brakoniecki, “Anesthetic Management of the Trauma Patient with Skeletal Injuries,” Skeletal Trauma, Ch. 7, Vol. 1, Pg. 171-172, ©1998 W.B. Saunders Company
VCF Treatment Options
Management for Pain
Medical management
? Bed rest — Exacerbates bone loss
? Narcotic analgesics — May fail to relieve pain, cause confusion
? Braces — May not provide long-term functional improvement

Open Surgical Treatment

Only in very rare cases of neurological deficit —
Invasive procedure with poor outcomes in osteopenic bone

II VCF Treatment Options
Management for Pain

Vertebroplasty

Deramond & Galibert, France, 1984

Vertebroplasty

? Pain ? in 80% of patients
? No cement failures
? Well-tolerated

BUT
? Up to 65% extra-vertebral cement leak
? Transient radicular pain in 3%
? Cement pulmonary embolism reported
? Cement in canal reported
Pulmonary Effects of Vertebroplasty
• Pressurized cement into cancellous bone
– Cement embolism
– Fat/marrow embolism
– PMMA monomer effects on lungs

Levine SA et al.Manag Care 2000
Padovani B et al. Am J Neuroradiol 1999
Perrin C et al. Rev Mal Respir 1999
Aebli N et al. Spine Vol. 27#5 2002
Vertebroplasty
Shortcomings

Vertebroplasty

Cement leakage

BALLOON KYPHOPLASTY Surgical Technique
Duration
• Injection: 10-15 minutes
• Cement to set: 7 minutes
• Whole procedure = 30 minutes
• Check neurology
• Sit up after procedure
• As out patient need 4-6 hours
Rehabilitation
• No specific precautions
• Back care advice
• Gradual strengthening of muscles
• Rapid return to normal function

ANAESTHETIC CONSIDERATIONS
? Local Anaesthesia
– Patient preference
– Patient may move
– Severe cardiopulmonary compromise

? Sedation + Local Anaesthetic
– Preferred method
– Patient most comfortable

Balloon Kyphoplasty
Balloon Kyphoplasty

IBT Insertion

? Insert IBT to within 4 mm of anterior cortex

? Inflate balloon to 50 psi (3.4 atm) to secure position while placing instruments through opposite pedicle into the vertebral body

IBT Inflation
? Once contralateral balloon is placed, inflate both IBT’s in 0.5cc increments

? Take A-P, lateral, and oblique images to monitor IBT position in relation to cortices

? Sequentially inflate until an inflation endpoint is reached
IBT Inflation Endpoints
? Realignment of vertebral endplates

? Maximum 400 psi (20.4 atm) without decay

? Maximum volume of balloon: 4cc for 15/3 and 10/3; 6cc for 20/3

Cementing
? Prepare a cement mix that is visible under fluoroscopy

? WAIT
– It is CRITICAL to wait until cement becomes highly viscous before delivery (does not drip from distal end of BFD).

– Impatience will result in extravasation (leakage) into the venous system or spinal canal.

Kyphoplasty vs Vertebroplasty
The issues
• Pain reduction
• Deformity correction
– Sagittal balance
– Risk of future fractures
– Risk of cement migration
• Safety
– Cement leakage
– Incident reporting
• Cost

Deformity Correction
Cases
Cases
Cases

Deformity Correction
Pre-op Post-op o Change
Thoracic VCFs 38o 29o +9o
Lumbar VCFs 10o 17o +7o
All VCFs +8o
Reducible VCFs* +14o
Degree of compression measurement
Correct Measurements
Deformity Correction
Kyphoplasty – Deformity Correction
• Studies have suggested that kyphoplasty will restore vertebral body height by about 50% in 70% patients with VCFs

– Lieberman et al. Spine 2001
– Wong & Garfin J. Womens Imaging, 2000

Adjacent and New Fractures
Future Fracture Risk

Complications

Complications of Leakage
Costs
Costs
• Kyphoplasty reduces risk of further fracture by 50%.
• Bisphosphonates reduce risk of further fracture by 30%

• At 1year – cost neutral
• After 1 year – cost saving
Why a surgeon ?

– Diagnosis ! Exclude other pathology !
– Decisions on when to operate
– Options of treatment
– Biomechanics
– We know bone !

– Multidisciplinary approach !
Is this an osteoporotic Fracture ?
Staph Osteomyelitis
Availability of surgical facilities
• Operating Room – sterility, safety,

Imperial  College Protocol for VBCF’s
Multidisciplinary Working
Vertebroplasty for subsidence
Case 8 : LS 85 yrs old Female TB
Our practice
• High thoracic
• Minimal compression
• Early fractures without compression
• Previous multilevel fractures
• Unsuitable for GA