Kade Huntsman, MD a, Steven Scott, MD ab, Mauricio Berdugo, MD a, Stephen Roper, PA a Gregory Juda, PhD c

Transcription

1 EuroSpine 2011 Milan, Italy Kade Huntsman, MD a, Steven Scott, MD ab, Mauricio Berdugo, MD a, Stephen Roper, PA a Gregory Juda, PhD c a Salt Lake Orthopaedic Clinic, 1160 East 3900 South, Suite 5000, Salt Lake City, UT b Intermountain Healthcare, 5169 S. Cottonwood St, #430, Murray, UT, c Bacterin International, 600 Cruiser Lane, Belgrade, MT 59714

2 OsteoSponge consists of 100% human cancellous bone. Feature Benefit 100% Bone No carrier; most DBM putties/gels contain <50% bone. Osteoconductive Provides a natural interconnected, porous, cancellous scaffold with increased surface area for better cellular ingrowth, exposing bone growth inducing proteins to the healing environment. Osteoinductive Elastic, malleable properties Provides a host of signaling molecules that are involved in triggering the formation of new bone. May be shaped and compressed to fit in and around a variety of voids or spinal fusion devices. When compressed and inserted into a bone void, the graft will expand to fill the contours of the void, thus minimizing space between the void-graft interface. Sterile Convenient shelf life Delivery vehicle OsteoSponge is provided sterile in its final packaging. The product is sterilized by terminal gamma irradiation to provide a sterility assurance level of OsteoSponge is provided with a 5 year shelf life when stored at room temperature. May be loaded with BMA, PRP, or other cellular concentrates

3 OsteoSponge is regulated and approved as a bone void filler and can be used for any non structural bone grafting applications. Figure 1: A scanning electron microscope image of OsteoSponge demonstrates its open porous structure and large surface area. Figure 2: OsteoSponge can be easily compressed for Ideal product placement

4 Several grafting materials can be used in lumbar spinal fusion (i.e. allograft, autograft and rhbmp-2). To date no studies have compared the use of OsteoSponge vs. rhbmp-2 as an effective and comparable long-term option.

5 OsteoSponge (OS) as a graft material in a lumbar fusion model in conjunction with posterolateral fusion in single and multi-level procedures will be compared to rhbmp-2 (Infuse ) in a blinded manner to demonstrate equivalency.

6 STUDY DESIGN OUTCOME MEASURES Prospective, randomized, blinded two to three year cohort. Oswestry Disability Index (ODI) SF-36 v2 Visual Analog Scale (VAS) Radiologic findings such as: X-Ray (AP, Lat, Flex, Ext) Disc fusion Screw loosening, breakage or motion CT scan imaging of spine including Hounsfield scale units.

7 28 patients randomized: 16 to OsteoSponge 12 to rhbmp-2 PLIF procedure OsteoSponge or Infuse were placed in PEEK cages for anterior fusion. Posterolateral fusions were completed with synthetic bone graft. Clinical and radiologic data were analyzed. Figure 3: A PLIF cage loaded with OsteoSponge is inserted into the fusion site followed by an OsteoSponge block hydrated with BMA easily placed between the two cages.

8 Long-term data shows radiographic and CT scanning of OsteoSponge to be equivalent to rhbmp-2 in achieving an anterior fusion. Average X-Ray fusion rating: OsteoSponge (OS) = 3.85 rhbmp-2 = 3.72 (p=0.17) Figure 4. Example of a one-level rhbmp-2 fusion; solid fusion, good outcome Figure 5. Example of a one-level OsteoSponge fusion; solid interbody fusion.

9 VAS Leg Pain Leg pain (VAS score) in the OS group was reported as 2.46 compared to 2.83 for rhbmp-2 (p=0.21) *** SF-36 v2 score for OS group was 65.4 and for rhbmp-2 was ODI scores were 15.9 for OS and in the rhbmp-2 group 22.1, however the difference was not significant (p=0.45). Hounsfield unit measurements for fusion density were 194 for OS and 241 for rhbmp-2 (p=0.12); adjacent level density for OS was 178 and 163 for rhbmp-2. Back pain for the two groups was not statistically different year 2 year OS rhbmp-2

10 These results suggest that a comparable interbody fusion can be generated with OsteoSponge and bone marrow aspirate. OsteoSponge is not associated with ectopic bone formation, leg pain, or marked post-operative inflammatory response. Its use avoids the risk of an off-label procedure.

11 Kade Huntsman, MD DISCLOSURE 1) Consulting physician and patent holder for NuVasive, Inc 2) Shareholder, Bacterin, Inc. Steven Scott, MD DISCLOSURE Ownership Interest and paid board member, Bacterin, Inc. Authors Mauricio Berdugo, MD DISCLOSURE No conflicts of interest to report. Gregory Juda, PhD DISCLOSURE Paid salary employee of Bacterin, Inc. Stephen Roper, PA-C DISCLOSURE Ownership Interest/Shareholder for NuVasive, Inc.