COMPREHENSIVE “PRIMARY CARE” VERTEBROPLASTY CLINIC IN A FREE-STANDING,

RADIOLOGIST OWNED DIAGNOSTIC IMAGING CENTER-DIAGNOSTIC, TREATMENT, PREVENTION

AND FOLLOW-UP OF VCFs

BYH. PAUL HATTEN, Jr., M.D.INDIAN RIVER RADIOLOGY

VERO BEACH, FLORIDA, USA

DISCLOSURE

INDIAN RIVER COUNTY

•Full Time Population 141,667 (est. 2009)•Seasonal Population 163,531 (est. 2009)

INDIAN RIVER RADIOLOGY

Free Standing Diagnostic Imaging Center (DIC)

6,268 square feet4 Board Certified Radiolgists

EQUIPMENT

CT – Marconi MX 8000Fluoro

DEXA – GE LunarPlain Films

Ultrasound – Sequoia AcusonMRI – 1.0 Tesla Philips Open

OFFICE PROCEDURES

• SI Joint Injections• ESI’s

- CT Guidance• Bone Biopsies• Soft Tissue Biopsies

- CT- Ultrasound

VERTEBROPLASTIES

• HPH – CAQ Neuroradiology• Started Vertebroplasties 2000• 951 Vertebroplasties as of 8/31/2010

AMBULATORY SURGERY CENTER (ASC)

•Radiolgist helped organize and design•Siemens 23” C-Arm

New Technologies:

Novel Vertebroplasty Materials

CERAMENT™ Bi-Phasic Ceramic Bone Substitute:-

Enhances the bulk of cancellous bone:-

- Biologically

- Biomechanically

Bio-Material Characteristics 60 wt % α-calcium sulfate hemihydrate (CaS) 40 wt % hydroxyapatite (HA)

High injectability allows for minimal invasive delivery and ensures good intraosseal spread Iohexol-based radio-opacity enhancing component (liquid)

Makes the material visible under fluoroscopy

CERAMENT™ U.S.A. Pilot Results

•90% of 20 patients treated have complete pain relief •Pain improved from VAS 8.5 av. pre-op to 1.8 av. at one week •17 patients at 6 months with av. VAS of 1.2 •16 patients at 12 months with av. VAS of 0.6 •One adjacent level fractures to date 11 months post-surgery

At 12 weeks, there is extensive new bone formation, cement resorption, and cement incorporation in the bi-phasic ceramic-filled defect

CRITICAL DEFECT IN RABBIT

Empty Bi-Phasic Ceramic

C

CnB

nB

nB

Progression of Resorption of Cerament™ and Bone Incorporation beyond 1 year

Axial CT Scan, L1:Day 1

Axial CT Scan, L1:13 Months

Professional Bowler: Levels L3 & L4 Treated

Post Operative CT ScanPre Operative MRI

Returns to Professional Bowling in Las Vegas Tournament 14 days Post Cerament™ Vertebroplasty.

“PRIMARY CARE” VERTEBROPLASTY CLINIC

• Osteoporosis Counseling - Reclast Infusion Center - Calcium & Vitamin D• Vertebroplasty• Pain Management (no pain meds)

REQUEST

• Imaging• Pain Treatment - Vertebroplasty - ESI’s - SI Joint Injection - Facet Injections

PATIENT FOLLOW-UP

• RN Nurse Coordinator calls all pain management patients day following procedure.

• All Verterbroplasty patients called by Dr. Hatten evening of procedure.

• Any new pain and/or VCF call RN Nurse Coordinator.

OSTEOPOROSIS COUNSELING

• Vitamin D• Calcium• Bisphosphonate Treatment (Reduces

risk of VCF’s by 50%)

RECLAST INFUSION CENTER

• Initiated February 2009• Reclast (Zoledronic Acid – Novartis

Pharaceutical)• Annual Infusion

“PRIMARY CARE” VERTEBROPLASTY CLINIC

• VCF- Verebroplasty - Prevention- Follow-up- New VCF’s

• Spine Interventional Procedures- ESI’s- SI Joint Injections

• General Radiology Procedures