ࡱ> Y\Z]'` @bjbjLULU 4H.?.?l"4"bp/"1"1"1"1"1"1"$$h'ZU"9~~~U""fff~/"f~/"ffV P$"# "0",p(Fp(p(`r;fCgU"U"\ "~~~~  Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft Amir H. Fayyazi, MD, Rudolph Buckley, MD, Morgan Lorio, MD, PhilipYuan, MD, John G. DeVine, MD and Keisha K. Smith, BS Amir H. Fayyazi, MD, VSAS Orthopaedics, 1250 S. Cedar Crest Blvd., Suite 110, Allentown, PA 18104, Phone 610-435-1003, Fax 610-435-3188,  HYPERLINK "mailto:amirfayyazi@yahoo.com" amirfayyazi@yahoo.com Rudolph Buckley MD Hamilton Orthopaedic Surgery and sports Medicine 85 College Street Hamilton, NY 13346 Office: 315-824-1250 Email:  HYPERLINK "mailto:buckspine@aol.com" buckspine@aol.com Morgan Lorio, MD Neuro Spine Solutions 240 Medical Park Blvd, Suite 2700 Bristol, TN 37620 Office: 423-844-0501 Email:  HYPERLINK "mailto:drlorio@neurospinesolutions.net" drlorio@neurospinesolutions.net PhilipYuan, MD Orthopaedic Spine Surgeon Memorial Orthopaedic Surgical Group 2760 Atlantic Ave Long Beach, CA 90806 Office: 562-426-4145 Email:  HYPERLINK "mailto:psyuan@aol.com" psyuan@aol.com John G. DeVine, MD Eisenhower Army Medical Center Orthopedic Service 300 East Hospital Road Ft Gordon, GA 30905 Office: 706-787-1859 Email:  HYPERLINK "mailto:john.devine@us.army.mil" john.devine@us.army.mil Keisha K. Smith, BS Exactech, Inc. 2320 NW 66th Court Gainesville, FL 32653 Office: 352-377-1140 Email:  HYPERLINK "mailto:keisha.smith@exac.com" keisha.smith@exac.com Background Context: Theres been a widespread initiative to mitigate complications and costs associated with the harvest of autograftmainly iliac crest bone graft (ICBG)in spinal fusions. A demineralized bone matrix (DBM), when used as an extender of autogenous bone, can aid in minimizing harvesting requirements, thus avoiding the complications associated with ICBG harvest. Despite the wide spread use of DBM, there is little published data supporting its effectiveness. Optecure (Exactech Inc., Gainesville, FL) is a commercially available DBM product. Purpose: The purpose of this study is to compare a DBM autograft extender to autograft alone in patients undergoing 1 or 2 level fusion of the lumbar spine. Study Design/Setting: Single Blind, Multi-Center, Randomized, Prospective Clinical Study implemented at 6 US sites. Patient Sample: Ninety-four patients were enrolled, 82 randomized, 76 with at least 6 month follow-up. Outcome Measures: Oswestry Disability Index (ODI), SF-12 patient health surveys, and perceived pain noted on visual analog scales (VAS) were collected preoperatively and at 6-week, 3, 6, 12 and 24-month postoperative time points. Anteroposterior, lateral, flexion, and extension radiographs were taken. CT scan was obtained at 1-year. The amount of motion and the quality of the boney fusion was evaluated by an independent radiologist utilizing both films and CT. Methods: Patients suffering from lumbar stenosis and instability, failing conservative treatment and indicated for primary lumbar fusion, were enrolled into the study. All participating centers obtained IRB approval prior to initiation of study procedures. Patients were randomized to DBM+autograft or autograft only (21 local bone, 10 ICBG, and 5 local bone+ICBG). Surgical approaches include: posterolateral fusion (PLF), anterior lumbar interbody fusion (ALIF), combined posterolateral and interbody fusion (PLF/ILF), and interbody fusion (ILF). Operated levels ranged from L2-S1 and in each case instrumentation was utilized. Fusion was based on presence of continuous bridging trabecular bone in the interbody or posterolateral fusion, <5 degree angular motion, and d" 3mm translational motion on the flexion/extension radiographs. Statistical analysis was performed using independent t-test and chi-square. A p-value < 0.05 is considered statistically significant. Results: Seventy-six per protocol patients, with minimum 6 month follow-up, were evaluated. Thirty PLF, 18 ALIF, 24 PLF/ILF, and 4 ILF cases were enrolled into the study. There were 49 single level (27 DBM, 22 autograft) and 27 two level (17 DBM, 10 autograft) procedures. Intraoperative complications were noted in 7 patients; dural tear (4), pedicle fracture (1), coagulopathy (1), and unspecified (1). Significant improvement in VAS, ODI, and SF-12 measures were noted in both groups when compared to the pre-operative time point (Table 1). There were no statistically significant differences in clinical outcomes between the treatment groups. At 6 months, 22% of levels were noted to be fused (DBM 22%, autograft 23%), at 1 year, 64% of the levels were noted to be fused (DBM 65%, autograft 63%), and at 2 years, 83% of levels were noted to be fused (DBM 88%, autograft 79%). Similar fusion rates were noted in overall single-level (88%) and two-level (86%) cases at 2 years. One 2-level patient graded as fused was noted to have partial fracture of instrumentation at 12 and 24 months. There were no statistically significant differences in fusion between the DBM and autograft group at 6, 12 and 24 months (p=0.974, p=0.852 and p=0.311, respectively). 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Fayyazi, MD, Rudolph Buckley, MD, Morgan Lorio, MD, PhilipYuan, MD, John G. DeVine, MD and Keisha K. Smith, BS Amir H. Fayyazi, MD, VSAS Orthopaedics, 1250 S. Cedar Crest Blvd., Suite 110, Allentown, PA 18104, Phone 610-435-1003, Fax 610-435-3188,  HYPERLINK mailto:amirfayyazi@yahoo.comamirfayyazi@yahoo.com Rudolph Buckley MD Hamilton Orthopaedic Surgery and sports Medicine 85 College Street Hamilton, NY 13346 Office: 315-824-1250 Email:  HYPERLINK mailto:buckspine@aol.combuckspine@aol.com Morgan Lorio, MD Neuro Spine Solutions 240 Medical Park Blvd, Suite 2700 Bristol, TN 37620 Office: 423-844-0501 Email:  HYPERLINK mailto:drlorio@neurospinesolutions.netdrlorio@neurospinesolutions.net PhilipYuan, MD Orthopaedic Spine Surgeon Memorial Orthopaedic Surgical Group 2760 Atlantic Ave Long Beach, CA 90806 Office: 562-426-4145 Email:  HYPERLINK mailto:psyuan@aol.compsyuan@aol.com John G. DeVine, MD Eisenhower Army Medical Center Orthopedic Service 300 East Hospital Road Ft Gordon, GA 30905 Office: 706-787-1859 Email:  HYPERLINK mailto:john.devine@us.army.miljohn.devine@us.army.mil Keisha K. Smith, BS Exactech, Inc. 2320 NW 66th Court Gainesville, FL 32653 Office: 352-377-1140 Email:  HYPERLINK mailto:keisha.smith@exac.comkeisha.smith@exac.com Background Context: There s been a widespread initiative to mitigate complications and costs associated with the harvest of autograft mainly iliac crest bone graft (ICBG) in spinal fusions. A demineralized bone matrix (DBM), when used as an extender of autogenous bone, can aid in minimizing harvesting requirements, thus avoiding the complications associated with ICBG harvest. Despite the wide spread use of DBM, there is little published data supporting its effectiveness. Optecure (Exactech Inc., Gainesville, FL) is a commercially available DBM product. Purpose: The purpose of this study is to compare a DBM autograft extender to autograft alone in patients undergoing 1 or 2 level fusion of the lumbar spine. Study Design/Setting: Single Blind, Multi-Center, Randomized, Prospective Clinical Study implemented at 6 US sites. Patient Sample: Ninety-four patients were enrolled, 82 randomized, 76 with at least 6 month follow-up. Outcome Measures: Oswestry Disability Index (ODI), SF-12 patient health surveys, and perceived pain noted on visual analog scales (VAS) were collected preoperatively and at 6-week, 3, 6, 12 and 24-month postoperative time points. Anteroposterior, lateral, flexion, and extension radiographs were taken. CT scan was obtained at 1-year. The amount of motion and the quality of the boney fusion was evaluated by an independent radiologist utilizing both films and CT. Methods: Patients suffering from lumbar stenosis and instability, failing conservative treatment and indicated for primary lumbar fusion, were enrolled into the study. All participating centers obtained IRB approval prior to initiation of study procedures. Patients were randomized to DBM+autograft or autograft only (21 local bone, 10 ICBG, and 5 local bone+ICBG). Surgical approaches include: posterolateral fusion (PLF), anterior lumbar interbody fusion (ALIF), combined posterolateral and interbody fusion (PLF/ILF), and interbody fusion (ILF). Operated levels ranged from L2-S1 and in each case instrumentation was utilized. Fusion was based on presence of continuous bridging trabecular bone in the interbody or posterolateral fusion, <5 degree angular motion, and # 3mm translational motion on the flexion/extension radiographs. Statistical analysis was performed using independent t-test and chi-square. A p-value < 0.05 is considered statistically significant. Results: Seventy-six per protocol patients, with minimum 6 month follow-up, were evaluated. Thirty PLF, 18 ALIF, 24 PLF/ILF, and 4 ILF cases were enrolled into the study. There were 49 single level (27 DBM, 22 autograft) and 27 two level (17 DBM, 10 autograft) procedures. Intraoperative complications were noted in 7 patients; dural tear (4), pedicle fracture (1), coagulopathy (1), and unspecified (1). Significant improvement in VAS, ODI, and SF-12 measures were noted in both groups when compared to the pre-operative time point (Table 1). There were no statistically significant differences in clinical outcomes between the treatment groups. At 6 months, 22% of levels were noted to be fused (DBM 22%, autograft 23%), at 1 year, 64% of the levels were noted to be fused (DBM 65%, autograft 63%), and at 2 years, 83% of levels were noted to be fused (DBM 88%, autograft 79%). Similar fusion rates were noted in overall single-level (88%) and two-level (86%) cases at 2 years. One 2-level patient graded as fused was noted to have partial fracture of instrumentation at 12 and 24 months. There were no statistically significant differences in fusion between the DBM and autograft group at 6, 12 and 24 months (p=0.974, p=0.852 and p=0.311, respectively). Conclusions: The pain and morbidity associated with ICBG harvest site can be avoided by using a DBM graft as a graft extender. The results show that Optecure is an effective adjuvant to autogenous bone in single and 2-level lumbar fusions. 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