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102. Radiostereometric radiographic and safety results 3 to 6 years following a randomized study comparing osteogenic protein1 and autograft bone in human noninstrumented posterolateral lumbar fusions
Proceedings of the NASS 19th Annual Meeting / The Spine Journal 4 (2004) 3S–119S
Fig. 2. Matrix mRNA levels. culture in DMEM/F12 media with 10% FBS. When the cells became confluent they were trypsinized and then seeded into 6-well plates (200,000 cells/well) for another 3 days. The media were changed to 1% FBS DMEM/F12 media for the experiment. rhBMP-2, 7, 12, and 13 at the concentration of 333ng/ml were added to the culture media on day 0 and day 3. Total sulfated glycosaminoglycan (sGAG) in culture media were analyzed on day 6 by the DMMB assay. RT-PCR was used to determine mRNA relative levels of aggrecan, collagen I and collagen II at day 6. The results were expressed as the ratios to non-treatment groups. RESULTS: BMP-2 and BMP-7 were much more effective than BMP-12 or BMP-13 in increasing sGAG production by human or rat cells (Figs. 1, 2). The pattern of stimulation was similar between species. Aggrecan mRNA levels were increased highly by BMP-2, BMP-7, and modestly by BMP-13, and not changed by BMP-12 for both species. Collagen II mRNA levels were increased by BMP-2 and BMP-7 but not by BMP-12 or BMP13. Collagen I mRNA levels were unchanged by any of the BMPs in both rat and human. CONCLUSIONS: Because much of current research on disc therapy involves growth factors, it is important to compare some of the most commonly used molecules. Our results clearly show that BMP-2 and BMP-7 are far more effective in stimulating a cartilaginous disc matrix production than BMP-12 and BMP-13. The pattern of response to the BMPs by human and rat disc cells were very similar. DISCLOSURES: Device or drug: BMP-2, -7, -12, and -13. Status: Investigational/Not approved. Device or drug: Status: Not approved for this indication. CONFLICT OF INTEREST: Author (SY) Grant Research Support: Medtronic Sofamor Danek Research Grant. doi: 10.1016/j.spinee.2004.05.102
Saturday, October 30, 2004 1:50–2:35 PM Concurrent Sessions 5B: Spine Surgery–Fusion Promoters and Disc Degeneration 1:50 102. Radiostereometric radiographic and safety results 3 to 6 years following a randomized study comparing osteogenic protein1 and autograft bone in human noninstrumented posterolateral lumbar fusions Ragnar Johnsson, Bjo¨rn Stro¨mqvist, Per Aspenberg; Lund University Hospital, Lund, Sweden BACKGROUND CONTEXT: Animal studies of osteoinductive proteins in noninstrumented posterolateral fusions have shown high fusion rates. No similar conclusive study on humans has been performed. PURPOSE: To determine whether Osteogenic Protein-1 (BMP-7) in the OP-1 Implant continues to yield better stabilizing bony fusion at 3 to 6 years postoperatively than autograft bone. STUDY DESIGN/SETTING: Randomized efficacy trial comparing two types of noninstrumented posterolateral fusion between L5 and S1 in
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patients with L5 spondylolisis and vertebral slip less than 50% as evaluated by radiostereometric analysis. PATIENT SAMPLE: 20 patients were randomized to noninstrumented posterolateral lumbar fusion with either OP-1 Implant or autograft bone from the iliac crest, 10 in each group. OUTCOME MEASURES: At surgery 0.8-mm metallic markers had been positioned in sacrum and L5 enabling follow-up with radiostereometric analysis (RSA). METHODS: The three-dimensional vertebral movements as measured by RSA induced by positional change from supine to standing and sitting were calculated with an accuracy of 0.5–0.7 mm and 0.5–2.0 degrees. Conventional radiography was added. RESULTS: At 1 year, those fusions healed showed no significant difference between the radiostereometric and radiographic results of fusion with the OP1 Implant and fusion with autograft bone. During the 3 to 6 year followup period, the rate of intervertebral stabilization as measured by RSA and signs of bridging bone on conventional radiography remained rigid over time. Increased intervertebral stability was added to fusions not rigid at one year as measured by RSA and radiography. No adverse effects of the OP-1 Implant and no pain at the iliac crest following bone harvest occured. CONCLUSIONS: Noninstrumented posterolateral lumbar fusion with OP1 Implant can provide lasting fusion healing without adding any adverse effects of the OP-1 Implant. DISCLOSURES: Device or drug: OP-1 Implant. Status: Investigational/ Not approved. CONFLICT OF INTEREST: No Conflicts. doi: 10.1016/j.spinee.2004.05.103 1:57 103. Randomized prospective controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion Kevin Foley; Semmes-Murphey Clinic and Department of Neurosurgery, University of Tennessee, Memphis, Memphis, TN, USA BACKGROUND CONTEXT: Pulsed electromagnetic field stimulation (PEMF) has been demonstrated to improve lumbar fusion rates. There are no published studies regarding the use of PEMF as an adjunct to cervical fusion. PURPOSE: To determine the safety and efficacy of PEMF as an adjunct to cervical spine fusion. STUDY DESIGN/SETTING: Randomized, prospective, controlled, multicenter clinical trial. PATIENT SAMPLE: Patients with symptomatic radiculopathy and correlating radiographic evidence of cervical nerve root compression were candidates for entry into the study. All patients were either smokers (at least one pack/day) or required multi-level surgery and underwent anterior cervical discectomy and Smith-Robinson fusion using allograft bone and anterior cervical plating (single plating system). Three-hundred-twenty-three patients were enrolled in the study; 160 in the non-PEMF (control) group and 163 in the PEMF group. Both groups were comparable with regard to gender, age, race and risk factors. Equal numbers were lost to follow-up in both groups. OUTCOME MEASURES: Outcome measures included a focused neurological exam, a visual analogue scale for pain, the Oswestry Neck Disability Index (NDI) for function, and radiographs for fusion assessment. Radiographs were read blindly by two independent orthopedic spine surgeons as well as an independent radiologist and rated as “fused” or “not fused” based upon radiolucency, bony bridging, and motion on flexion-extension views. METHODS: Patients were randomized to receive pulsed electromagnetic field stimulation (PEMF) or not (non-PEMF). They were assessed preoperatively and at 1, 2, 3, 6, and 12 months postoperatively and annually thereafter until the last patient enrolled had reached 12 months follow-up. All patients were followed for adverse events to assess safety. RESULTS: Of the 240 patients available for evaluation at 6 months, the fusion rate was 83.6% (102/122) in the PEMF group and 68.6% (81/118)
Fig. 2. Matrix mRNA levels. culture in DMEM/F12 media with 10% FBS. When the cells became confluent they were trypsinized and then seeded into 6-well plates (200,000 cells/well) for another 3 days. The media were changed to 1% FBS DMEM/F12 media for the experiment. rhBMP-2, 7, 12, and 13 at the concentration of 333ng/ml were added to the culture media on day 0 and day 3. Total sulfated glycosaminoglycan (sGAG) in culture media were analyzed on day 6 by the DMMB assay. RT-PCR was used to determine mRNA relative levels of aggrecan, collagen I and collagen II at day 6. The results were expressed as the ratios to non-treatment groups. RESULTS: BMP-2 and BMP-7 were much more effective than BMP-12 or BMP-13 in increasing sGAG production by human or rat cells (Figs. 1, 2). The pattern of stimulation was similar between species. Aggrecan mRNA levels were increased highly by BMP-2, BMP-7, and modestly by BMP-13, and not changed by BMP-12 for both species. Collagen II mRNA levels were increased by BMP-2 and BMP-7 but not by BMP-12 or BMP13. Collagen I mRNA levels were unchanged by any of the BMPs in both rat and human. CONCLUSIONS: Because much of current research on disc therapy involves growth factors, it is important to compare some of the most commonly used molecules. Our results clearly show that BMP-2 and BMP-7 are far more effective in stimulating a cartilaginous disc matrix production than BMP-12 and BMP-13. The pattern of response to the BMPs by human and rat disc cells were very similar. DISCLOSURES: Device or drug: BMP-2, -7, -12, and -13. Status: Investigational/Not approved. Device or drug: Status: Not approved for this indication. CONFLICT OF INTEREST: Author (SY) Grant Research Support: Medtronic Sofamor Danek Research Grant. doi: 10.1016/j.spinee.2004.05.102
Saturday, October 30, 2004 1:50–2:35 PM Concurrent Sessions 5B: Spine Surgery–Fusion Promoters and Disc Degeneration 1:50 102. Radiostereometric radiographic and safety results 3 to 6 years following a randomized study comparing osteogenic protein1 and autograft bone in human noninstrumented posterolateral lumbar fusions Ragnar Johnsson, Bjo¨rn Stro¨mqvist, Per Aspenberg; Lund University Hospital, Lund, Sweden BACKGROUND CONTEXT: Animal studies of osteoinductive proteins in noninstrumented posterolateral fusions have shown high fusion rates. No similar conclusive study on humans has been performed. PURPOSE: To determine whether Osteogenic Protein-1 (BMP-7) in the OP-1 Implant continues to yield better stabilizing bony fusion at 3 to 6 years postoperatively than autograft bone. STUDY DESIGN/SETTING: Randomized efficacy trial comparing two types of noninstrumented posterolateral fusion between L5 and S1 in
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patients with L5 spondylolisis and vertebral slip less than 50% as evaluated by radiostereometric analysis. PATIENT SAMPLE: 20 patients were randomized to noninstrumented posterolateral lumbar fusion with either OP-1 Implant or autograft bone from the iliac crest, 10 in each group. OUTCOME MEASURES: At surgery 0.8-mm metallic markers had been positioned in sacrum and L5 enabling follow-up with radiostereometric analysis (RSA). METHODS: The three-dimensional vertebral movements as measured by RSA induced by positional change from supine to standing and sitting were calculated with an accuracy of 0.5–0.7 mm and 0.5–2.0 degrees. Conventional radiography was added. RESULTS: At 1 year, those fusions healed showed no significant difference between the radiostereometric and radiographic results of fusion with the OP1 Implant and fusion with autograft bone. During the 3 to 6 year followup period, the rate of intervertebral stabilization as measured by RSA and signs of bridging bone on conventional radiography remained rigid over time. Increased intervertebral stability was added to fusions not rigid at one year as measured by RSA and radiography. No adverse effects of the OP-1 Implant and no pain at the iliac crest following bone harvest occured. CONCLUSIONS: Noninstrumented posterolateral lumbar fusion with OP1 Implant can provide lasting fusion healing without adding any adverse effects of the OP-1 Implant. DISCLOSURES: Device or drug: OP-1 Implant. Status: Investigational/ Not approved. CONFLICT OF INTEREST: No Conflicts. doi: 10.1016/j.spinee.2004.05.103 1:57 103. Randomized prospective controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion Kevin Foley; Semmes-Murphey Clinic and Department of Neurosurgery, University of Tennessee, Memphis, Memphis, TN, USA BACKGROUND CONTEXT: Pulsed electromagnetic field stimulation (PEMF) has been demonstrated to improve lumbar fusion rates. There are no published studies regarding the use of PEMF as an adjunct to cervical fusion. PURPOSE: To determine the safety and efficacy of PEMF as an adjunct to cervical spine fusion. STUDY DESIGN/SETTING: Randomized, prospective, controlled, multicenter clinical trial. PATIENT SAMPLE: Patients with symptomatic radiculopathy and correlating radiographic evidence of cervical nerve root compression were candidates for entry into the study. All patients were either smokers (at least one pack/day) or required multi-level surgery and underwent anterior cervical discectomy and Smith-Robinson fusion using allograft bone and anterior cervical plating (single plating system). Three-hundred-twenty-three patients were enrolled in the study; 160 in the non-PEMF (control) group and 163 in the PEMF group. Both groups were comparable with regard to gender, age, race and risk factors. Equal numbers were lost to follow-up in both groups. OUTCOME MEASURES: Outcome measures included a focused neurological exam, a visual analogue scale for pain, the Oswestry Neck Disability Index (NDI) for function, and radiographs for fusion assessment. Radiographs were read blindly by two independent orthopedic spine surgeons as well as an independent radiologist and rated as “fused” or “not fused” based upon radiolucency, bony bridging, and motion on flexion-extension views. METHODS: Patients were randomized to receive pulsed electromagnetic field stimulation (PEMF) or not (non-PEMF). They were assessed preoperatively and at 1, 2, 3, 6, and 12 months postoperatively and annually thereafter until the last patient enrolled had reached 12 months follow-up. All patients were followed for adverse events to assess safety. RESULTS: Of the 240 patients available for evaluation at 6 months, the fusion rate was 83.6% (102/122) in the PEMF group and 68.6% (81/118)