1
RESULTS: Back pain improved from 8-10 VAS preoperatively to 1-3 one month after surgery. Patients reported a dramatic reduction of back pain within hours after transpedicular drainage, while pain was progressively decreased during the first month after open procedures. Patients with epidural abscess (n56) had complete recovery from radiculopathy. The patient with Frankel C paraparesis became ambulatory (Frankel D), and regained her previous activities. Clinical sequelae at the latest follow-up visit were classified as normal in 7 patients, and mild in 3. One patient treated with laminectomy and posterolateral fusion experience recurrence of infection, 9 months after initial treatment. CONCLUSIONS: Clinical manifestation of spinal brucellosis can include spondylitis, spondylodiscitis, discitis, epidural abscess, paraspinal abscess, and vertebral collapse. Pecutaneous transpedicular discectomy and drain- age is cost-effective, promoting relief of pain and healing in cases without severe neurological deficit. Though there are reports that almost half of the epidural abscesses are asymptomatic, we encountered neurological symp- toms in all our patients. Surgical drainage of the abscesses or discectomy and drainage of the infected disc herniation resolved neurological symp- toms in all patients in this series and led to uneventful recovery. Drainage of the abscess in the lumbar region was successfully performed through posterior approach and laminectomy. Relapse rate was 1.1%, which is far less than the reported range of 4% to 14%. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. CONFLICT OF INTEREST: No conflicts. doi: 10.1016/j.spinee.2006.06.315 P107. Augmentation of Osseous Phenotypes In Vivo With a Synthetic Peptide Brent Atkinson, PhD 1 , Xinhua Lin, PhD 1 , Louis Pena, PhD 2 , Casey Fox 3 , Kazuyuki Takahashi 1 , Paul Zamora, PhD 1 ; 1 BioSET Inc., Rockville, MD, USA; 2 Brookhaven National Laboratory, Upton, NY, USA; 3 Biomedical Enterprises, TX, USA BACKGROUND CONTEXT: There is clinical need for synthetic, os- teoinductive materials that eliminate the morbidity associated with harvest- ing autogenous bone. A combination of osteoconductive materials with B2A2, a multi-domain synthetic peptide, represents a potentially unique approach to address this need. B2A2 amplifies the in vitro effects of BMP-2, and could, in principle, amplify host BMPs during bone repair. PURPOSE: The present study evaluated if B2A2 peptide could improve osteogenic responses in rat and rabbit animal models. An improved osteo- genic response would provide a rationale for additional studies targeting spinal fusion. STUDY DESIGN/SETTING: Two animal studies were conducted under IACUC-approved protocols: ectopic mineralization in athymic rats and ulna defect repair in rabbits. Results were evaluated radiographically and histologically. In athymic rats, human demineralized bone matrix (DBM) was used as a source of BMPs. In the rabbit ulna model, the host was used as the ‘‘source’’ of endogenous BMPs (no exogenous source of BMP was used). PATIENT SAMPLE: N/A. OUTCOME MEASURES: N/A. METHODS: Rats (n56 per group) received bilateral subcutaneous im- plants on the upper flanks and into pouches. The animals were implanted with carrier only or carrier containing human demineralized bone matrix (DBM) with or without B2A2 (4 doses), then examined at 4 weeks. In rab- bits (n56 per group), ulnas were surgically exposed and 1/8’’ bicortical drill holes made. The defects were left unfilled or filled with carrier formu- lated with or without doses of B2A2. One additional group was filled with autograft. Animals were evaluated at 6 weeks. RESULTS: In the athymic rats, sites that received carrier only had low levels of mineralization as determined as low radio-opacity and low histo- logical staining with von Kossa’s stain. Mineralization, increased radio density, and von Kossa staining were detected in sites implanted with DBM plus carrier. However, a statistically significant increase in radio- opacity and von Kossa staining was seen when B2A2 was included with DBM/carrier as compared with DBM or carrier alone. The augmentation was observed with several doses of B2A2. In the rabbit ulna repair model, mineralization as detected radiographically was low in the untreated, empty defects sites. Similarly, defects treated with carrier only lacked opacity. However, increased opacity was found in the defects treated with B2A2. The increase in radiographic density was observed over a log of doses. Two doses demonstrated statistically significant increases above empty defects. The resultant defect closures were similar to those treated with autograft. Histologically, B2A2 also generally demonstrated more ac- tive bone healing compared with control or autograft treated sites. Little or no inflammation or foreign body giant cell response was observed in sites receiving B2A2, and no anti-peptide antibodies were detected (Fig. 1). CONCLUSIONS: B2A2 can augment osseous phenotypes when placed in osteoinductive environments in vivo. In the carrier used, B2A2 was bio- compatible and did not produce uncontrolled growth of new bone. While significant advanced studies are required, these results suggest that B2A2 may have clinical utility and current efforts are focused on spinal fusion applications. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. CONFLICT OF INTEREST: Authors (BA, LP, CF, KT, PZ, XL) Stock- holder: BioSurface Engineering Technologies, Inc.; Authors (BA, XL, KT, PZ) Employee: BioSurface Engineering Technologies, Inc.; Author (CF) Grant/Research Support: BioSurface Engineering Technologies, Inc. doi: 10.1016/j.spinee.2006.06.316 P108. Anterior Allograft Bone Dowel Treatment of Pyogenic Vertebral Osteomyelitis Michael Dabbah, MD 1 , Justin Tortolani, MD 2 , Ira L. Fedder, MD 3 , Farhan Siddiqi, MD 1 , Victor Hayes, MD 1 , Paul McAfee, MD 3 ; 1 Maryland Spinal Reconstructive Surgery Fellowship, Towson, MD, USA; 2 Union Memorial Hospital, Towson, MD, USA; 3 Spine and Scoliosis Center, Towson, MD, USA BACKGROUND CONTEXT: Pyogenic vertebral osteomyelitis is a rare clinical problem which usually responds to immobilization and intrave- nous antibiotics. Failure of medical management requires operative treat- ment consisting of anterior debridement and anterior column reconstruction. Structural iliac crest autograft is currently considered the gold standard but involves morbidity associated with the harvest. PURPOSE: The purpose of this study was to evaluate the use of allograft bone dowels for interbody reconstruction after anterior debridement in the treatment of pyogenic vertebral osteomyelitis. STUDY DESIGN/SETTING: Retrospective series. Fig. 1. Radiographic scores from rabbit ulna defects after 6 weeks. 135S Proceedings of the NASS 21st Annual Meeting / The Spine Journal 6 (2006) 1S–161S

P107. Augmentation of Osseous Phenotypes In Vivo With a Synthetic Peptide

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Page 1: P107. Augmentation of Osseous Phenotypes In Vivo With a Synthetic Peptide

RESULTS: Back pain improved from 8-10 VAS preoperatively to 1-3 one

month after surgery. Patients reported a dramatic reduction of back pain

within hours after transpedicular drainage, while pain was progressively

decreased during the first month after open procedures. Patients with

epidural abscess (n56) had complete recovery from radiculopathy. The

patient with Frankel C paraparesis became ambulatory (Frankel D), and

regained her previous activities. Clinical sequelae at the latest follow-up

visit were classified as normal in 7 patients, and mild in 3. One patient

treated with laminectomy and posterolateral fusion experience recurrence

of infection, 9 months after initial treatment.

CONCLUSIONS: Clinical manifestation of spinal brucellosis can include

spondylitis, spondylodiscitis, discitis, epidural abscess, paraspinal abscess,

and vertebral collapse. Pecutaneous transpedicular discectomy and drain-

age is cost-effective, promoting relief of pain and healing in cases without

severe neurological deficit. Though there are reports that almost half of the

epidural abscesses are asymptomatic, we encountered neurological symp-

toms in all our patients. Surgical drainage of the abscesses or discectomy

and drainage of the infected disc herniation resolved neurological symp-

toms in all patients in this series and led to uneventful recovery. Drainage

of the abscess in the lumbar region was successfully performed through

posterior approach and laminectomy. Relapse rate was 1.1%, which is

far less than the reported range of 4% to 14%.

FDA DEVICE/DRUG STATUS: This abstract does not discuss or include

any applicable devices or drugs.

CONFLICT OF INTEREST: No conflicts.

doi: 10.1016/j.spinee.2006.06.315

P108. Anterior Allograft Bone Dowel Treatment of Pyogenic

Vertebral Osteomyelitis

Michael Dabbah, MD1, Justin Tortolani, MD2, Ira L. Fedder, MD3,

Farhan Siddiqi, MD1, Victor Hayes, MD1, Paul McAfee, MD3; 1Maryland

Spinal Reconstructive Surgery Fellowship, Towson, MD, USA; 2Union

Memorial Hospital, Towson, MD, USA; 3Spine and Scoliosis Center,

Towson, MD, USA

BACKGROUND CONTEXT: Pyogenic vertebral osteomyelitis is a rare

clinical problem which usually responds to immobilization and intrave-

nous antibiotics. Failure of medical management requires operative treat-

ment consisting of anterior debridement and anterior column

reconstruction. Structural iliac crest autograft is currently considered the

gold standard but involves morbidity associated with the harvest.

PURPOSE: The purpose of this study was to evaluate the use of allograft

bone dowels for interbody reconstruction after anterior debridement in the

treatment of pyogenic vertebral osteomyelitis.

STUDY DESIGN/SETTING: Retrospective series.

135SProceedings of the NASS 21st Annual Meeting / The Spine Journal 6 (2006) 1S–161S

P107. Augmentation of Osseous Phenotypes In Vivo With a Synthetic

Peptide

Brent Atkinson, PhD1, Xinhua Lin, PhD1, Louis Pena, PhD2, Casey Fox3,

Kazuyuki Takahashi1, Paul Zamora, PhD1; 1BioSET Inc., Rockville, MD,

USA; 2Brookhaven National Laboratory, Upton, NY, USA; 3Biomedical

Enterprises, TX, USA

BACKGROUND CONTEXT: There is clinical need for synthetic, os-

teoinductive materials that eliminate the morbidity associated with harvest-

ing autogenous bone. A combination of osteoconductive materials with

B2A2, a multi-domain synthetic peptide, represents a potentially unique

approach to address this need. B2A2 amplifies the in vitro effects of

BMP-2, and could, in principle, amplify host BMPs during bone repair.

PURPOSE: The present study evaluated if B2A2 peptide could improve

osteogenic responses in rat and rabbit animal models. An improved osteo-

genic response would provide a rationale for additional studies targeting

spinal fusion.

STUDY DESIGN/SETTING: Two animal studies were conducted under

IACUC-approved protocols: ectopic mineralization in athymic rats and

ulna defect repair in rabbits. Results were evaluated radiographically and

histologically. In athymic rats, human demineralized bone matrix (DBM)

was used as a source of BMPs. In the rabbit ulna model, the host was used

as the ‘‘source’’ of endogenous BMPs (no exogenous source of BMP was

used).

PATIENT SAMPLE: N/A.

OUTCOME MEASURES: N/A.

METHODS: Rats (n56 per group) received bilateral subcutaneous im-

plants on the upper flanks and into pouches. The animals were implanted

with carrier only or carrier containing human demineralized bone matrix

(DBM) with or without B2A2 (4 doses), then examined at 4 weeks. In rab-

bits (n56 per group), ulnas were surgically exposed and 1/8’’ bicortical

drill holes made. The defects were left unfilled or filled with carrier formu-

lated with or without doses of B2A2. One additional group was filled with

autograft. Animals were evaluated at 6 weeks.

RESULTS: In the athymic rats, sites that received carrier only had low

levels of mineralization as determined as low radio-opacity and low histo-

logical staining with von Kossa’s stain. Mineralization, increased radio

density, and von Kossa staining were detected in sites implanted with

DBM plus carrier. However, a statistically significant increase in radio-

opacity and von Kossa staining was seen when B2A2 was included with

DBM/carrier as compared with DBM or carrier alone. The augmentation

was observed with several doses of B2A2. In the rabbit ulna repair model,

mineralization as detected radiographically was low in the untreated,

empty defects sites. Similarly, defects treated with carrier only lacked

opacity. However, increased opacity was found in the defects treated with

B2A2. The increase in radiographic density was observed over a log of

doses. Two doses demonstrated statistically significant increases above

empty defects. The resultant defect closures were similar to those treated

with autograft. Histologically, B2A2 also generally demonstrated more ac-

tive bone healing compared with control or autograft treated sites. Little or

no inflammation or foreign body giant cell response was observed in sites

receiving B2A2, and no anti-peptide antibodies were detected (Fig. 1).

CONCLUSIONS: B2A2 can augment osseous phenotypes when placed in

osteoinductive environments in vivo. In the carrier used, B2A2 was bio-

compatible and did not produce uncontrolled growth of new bone. While

significant advanced studies are required, these results suggest that

B2A2 may have clinical utility and current efforts are focused on spinal

fusion applications.

FDA DEVICE/DRUG STATUS: This abstract does not discuss or include

any applicable devices or drugs.

CONFLICT OF INTEREST: Authors (BA, LP, CF, KT, PZ, XL) Stock-

holder: BioSurface Engineering Technologies, Inc.; Authors (BA, XL, KT,

PZ) Employee: BioSurface Engineering Technologies, Inc.; Author (CF)

Grant/Research Support: BioSurface Engineering Technologies, Inc.

doi: 10.1016/j.spinee.2006.06.316

Fig. 1. Radiographic scores from rabbit ulna defects after 6 weeks.