human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: In a prospect i ve series , the 24-month fusion status was evaluated radiographically among patients undergoing instrumented posterolateral lumbosacral spinal fusion . Seventy-three patients had a diagnosis of degenerative disk disease or degenerative spondylolisthesis and had supplemental bone grafting with demineralized bone matrix ( DBM ) putty ( Grafton DBM ; Osteotech , Eatontown , NJ ) enriched with aspirated bone marrow ( DBM bone marrow ) , DBM putty combined with iliac crest autograft ( DBM autograft ) , or autograft . Overall , approximately 63 % ( 12 of 19 ) of DBM bone marrow , 70 % ( 19 of 27 ) of DBM autograft , and 67 % ( 18 of 27 ) of autograft patients were fused at 24 months ( P = .875 ) . These findings suggest that both DBM composites offer similar performance to autograft in posterolateral spinal fusion Study Design . A prospect i ve , r and omized , controlled , multicenter clinical study . Objective . To compare the safety and clinical and radiographic outcomes of OP-1 ( BMP-7 ) Putty to autogenous iliac crest bone graft in a population of patients undergoing laminectomy and posterolateral fusion for symptomatic lumbar stenosis associated with degenerative spondylolisthesis . Summary of Background Data . Although the existing pre clinical and clinical data suggest that OP-1 is able to achieve osteoinduction and clinical fusion in a variety of situations , the efficacy of this recombinant protein in a clinical spine fusion population has not been fully eluci date d. This study directly compares the efficacy and safety of OP-1 putty to autograft bone for arthrodesis in patients with symptomatic stenosis in association with degenerative spondylolisthesis . Methods . Thirty-six patients with degenerative lumbar spondylolisthesis and symptoms of neurogenic claudication underwent laminectomy , bilateral medial facetectomy , and posterolateral fusion using either iliac crest autograft or OP-1 Putty .  Oswestry scores and SF-36 question naires were used to determine the clinical response to treatment . Independent , blinded neuroradiologists review ed both static and dynamic radiographs to determine the fusion status . Successful fusion was declared whenthe presence of continuous bridging bone between the transverse processes was observed and less than 5 ° of angular motion and 2 mm of translational movement was measured using digital calipers . Results . Efficacy data were tabulated for 27 patients at the 24-month time point and an additional 4 patients ( without evaluable 24-month results ) at the 36-month time point . One patient was not evaluable for radiology , so the data reflect clinical information for 31 patients and radiology for 30 patients .  Clinical success , defined as a 20 % improvement in the preoperative Oswestry score , was achieved by 17 of 20 ( 85 % ) OP-1 Putty patients and 7 of 11 ( 64 % ) autograft patients . A successful posterolateral fusion was achieved in 11 of 20 ( 55 % ) OP-1 Putty patients and 4 of 10 ( 40 % ) autograft patients . SF-36 scores showed similar clinical improvement in both groups . No systemic toxicity , ectopic bone formation , recurrent stenosis , or other adverse events specifically related to the use of the OP-1 Putty implant were observed . Conclusion . This study represents the first clinical trial to demonstrate the safety and similarity of OP-1 Putty as a replacement for autogenous bone graft in the posterolateral fusion environment with a minimum of 2-year follow-up . OP-1 Putty was able to achieve osteoinduction leading to a radiographically solid fusion in the absence of autogenous iliac crest bone graft in 55 % of the patients at 24 and 36 months . These results compare favorably to the historical fusion rates reported for uninstrumented arthrodesis in this challenging clinical scenario Study Design . Prospect i ve multicenter r and omized clinical trail . Objective . The goal of our 2-year prospect i ve study was to perform a r and omized clinical trial comparing the outcomes of Grafton demineralized bone matrix ( DBM ) Matrix with local bone with that of iliac crest bone graft ( ICBG ) in a single-level instrumented posterior lumbar fusion . Summary of Background Data . There has been extensive research and development in identifying a suitable substitute to replace autologous ICBG that is associated with known morbidities . DBMs are a class of commercially available grafting agents that are prepared from allograft bone . Many such products have been commercially available for clinical use ; however , their efficacy for spine fusion has been mostly based on anecdotal evidence rather than r and omized controlled clinical trials . Methods . Forty-six patients were r and omly assigned ( 2:1 ) to receive Grafton DBM Matrix with local bone ( 30 patients ) or autologous ICBG ( 16 patients ) . The mean age was 64 ( females [ F ] = 21 , males [ M ] = 9 ) in the DBM group and 65 ( F = 9 , M = 5 ) in the ICBG group . An independent radiologist evaluated plain radiographs and computed tomographic scans at 6-month , 1-year , and 2-year time points . Clinical outcomes were measured using Oswestry Disability Index ( ODI ) and Medical Outcomes Study 36-Item Short Form Health Survey . Results . Forty-one patients ( DBM = 28 and ICBG = 13 ) completed the 2-year follow-up .  Final fusion rates were 86 % ( Grafton Matrix ) versus 92 % ( ICBG ) ( P = 1.0 not significant ) . The Grafton group showed slightly better improvement in ODI score than the ICBG group at the final 2-year follow-up ( Grafton [ 16.2 ] and ICBG [ 22.7 ] ) ; however , the difference was not statistically significant ( P = 0.2346 at 24 mo ) . Grafton showed consistently higher physical function scores at 24 months ; however , differences were not statistically significant ( P = 0.0823 ) . Similar improvements in the physical component summary scores were seen in both the Grafton and ICBG groups . There was a statistically significant greater mean intraoperative blood loss in the ICBG group than in the Grafton group ( P < 0.0031 ) . Conclusion . At 2-year follow-up , subjects who were r and omized to Grafton Matrix and local bone achieved an 86 % overall fusion rate and improvements in clinical outcomes that were comparable with those in the ICBG group Study Design . Prospect i ve r and omized controlled trial of rhBMP-2/ACS ( Infuse bone graft ) versus iliac crest bone graft ( ICBG ) for lumbar spine fusion in patients over 60 years of age . Objective . To report on clinical , radiographic , and economic outcomes , at 2-year follow-up , in patients treated by posterolateral lumbar fusion with rhBMP-2/ACS versus ICBG .  Summary of Background Data . RhBMP-2/ACS is widely used “ off-label ” for posterolateral spinal fusion . Despite encouraging initial reports , outst and ing issues include the need for evidence regarding safety and efficacy in an older population ; and an assessment of cost-effectiveness . Methods . Patients over 60 years old were r and omized to rhBMP-2/ACS ( n = 50 ) or ICBG ( n = 52 ) .  Oswestry Disability Index , Short Form-36 , and numerical rating scales for back and leg pain were determined preoperatively and at 6 , 12 , and 24 months postoperatively . Fusion was evaluated by fine-cut computed tomography scan 2 years postoperatively by 3 review ers . All in-patient and subsequent out-patient event costs were recorded by a dedicated hospital coder . Results . Two-year postoperative improvement in Oswestry Disability Index averaged 15.8 in the rhBMP-2/ACS group and 13.0 in the ICBG group . Mean improvement in Short Form-36 physical component score was 6.6 in the rhBMP-2/ACS group and 7.5 in the ICBG group . There were 20 complications in the ICBG group and 8 complications in the rhBMP-2/ACS group ( P = 0.014 ) . Sixteen ICBG and 10 rhBMP-2/ACS patients required additional treatment for persistent back or leg symptoms . Two rhBMP-2/ACS patients had revision procedures , 1 for nonunion . Eight patients in the ICBG group had revision procedures , 5 for nonunion . Mean fusion grade on computed tomography scan was significantly ( P = 0.030 ) better in the rhBMP-2/ACS ( 4.3 ) compared with the ICBG group ( 3.8 ) . Mean cost of the initial admission was $ 36,530 in the rhBMP-2/ACS group and $ 34,235 in the iliac crest bone graft ( ICBG ) group . Total cost of care over 2 years was $ 42,574 for the ICBG group and $ 40,131 for the rhBMP-2/ACS group . Conclusion . RhBMP-2/ACS is a viable ICBG replacement in older patients in terms of safety , clinical efficacy , and cost-effectiveness BACKGROUND CONTEXT Although autogenous bone is still considered to be the gold st and ard graft material for promoting spinal fusion , other bone graft substitutes have been developed in an attempt to improve arthrodesis rates and avoid the complications associated with the procurement of autograft . The bone morphogenetic proteins ( BMPs ) represent a family of osteoinductive growth factors that are known to stimulate the osteoblastic differentiation of stem cells . Osteogenic protein-1 ( OP-1 ) Putty is a commercially available BMP preparation that is already approved for use in humans . Previous clinical studies involving patients with degenerative spondylolisthesis have reported that the efficacy and safety of OP-1 Putty is comparable to that of autograft at both 1- and 2-year follow-up . PURPOSE The purpose of this study was to evaluate the intermediate-term efficacy and safety of OP-1 Putty as an alternative to autogenous bone by comparing the 4-year radiographic , clinical , and safety data of these same patients who underwent decompression and uninstrumented fusion with either OP-1 Putty or iliac crest autograft .  STUDY DESIGN / SETTING A prospect i ve , r and omized , controlled , multicenter clinical pilot study . PATIENT SAMPLE Thirty-six patients undergoing decompressive laminectomy and single-level uninstrumented fusion for degenerative spondylolisthesis and symptomatic spinal stenosis were r and omized in a 2:1 fashion to receive either OP-1 Putty ( 24 patients ) or autogenous iliac crest bone graft ( 12 patients ) . OUTCOME MEASURES Patient-reported outcome measures consisting of Oswestry Disability Index and Medical Outcomes Study 36-Item Short Form Health Survey ( SF-36 ) scores were used to evaluate clinical efficacy . Perioperative data including operative time , estimated blood loss , and duration of hospital stay were also recorded for each surgery . Postoperatively , a neurological examination and an assessment of donor-site pain ( if applicable ) were performed at every follow-up visit . Radiographic fusion success was defined as the presence of continuous bridging bone formation between the transverse processes at the level of the spondylolisthesis with minimal motion evident on dynamic lateral x-ray films . The primary efficacy endpoint was the overall success rate , a composite measure derived from both radiographic and clinical parameters . The safety of OP-1 Putty was confirmed by comparing the nature and frequency of all adverse events and complications that were prospect ively observed in either of the groups . METHODS Thirty-six patients with degenerative spondylolisthesis and symptoms of neurogenic claudication underwent decompressive laminectomy and single-level uninstrumented fusion with either OP-1 Putty or autograft . All patients were evaluated at 6 weeks and 3 , 6 , 9 , 12 , and 24 months , after which time they were instructed to return on a yearly basis . Multiple neuroradiologists blinded to the assigned treatment review ed static and dynamic X-ray films with digital calipers to assess fusion status according to the presence of continuous bridging bone across the transverse processes as well as the amount of residual motion evident at the level of interest . Oswestry Disability Index surveys and SF-36 question naires were used to assess clinical outcomes . RESULTS At the 48-month time point , complete radiographic and clinical data were available for 22 of 36 patients ( 16 OP-1 Putty and 6 autograft ) and 25 of 36 patients ( 18 OP-1 Putty and 7 autograft ) , respectively . Radiographic evidence of a solid arthrodesis was present in 11 of 16 OP-1 Putty patients ( 68.8 % ) and 3 of 6 autograft patients ( 50 % ) . Clinical ly successful outcomes defined as at least a 20 % improvement in preoperative Oswestry scores were experienced by 14 of 19 OP-1 Putty patients ( 73.7 % ) and 4 of 7 autograft patients ( 57.1 % ) ; these clinical findings were corroborated by similar increases in SF-36 scores . The respective overall success rates of the OP-1 Putty and autograft group were 62.5 % and 33.3 % . In this study , there were no incidents of local or systemic toxicity , ectopic bone production , or other adverse events directly 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: In a prospect i ve series , the 24-month fusion status was evaluated radiographically among patients undergoing instrumented posterolateral lumbosacral spinal fusion . Seventy-three patients had a diagnosis of degenerative disk disease or degenerative spondylolisthesis and had supplemental bone grafting with demineralized bone matrix ( DBM ) putty ( Grafton DBM ; Osteotech , Eatontown , NJ ) enriched with aspirated bone marrow ( DBM bone marrow ) , DBM putty combined with iliac crest autograft ( DBM autograft ) , or autograft . Overall , approximately 63 % ( 12 of 19 ) of DBM bone marrow , 70 % ( 19 of 27 ) of DBM autograft , and 67 % ( 18 of 27 ) of autograft patients were fused at 24 months ( P = .875 ) . These findings suggest that both DBM composites offer similar performance to autograft in posterolateral spinal fusion Study Design . A prospect i ve , r and omized , controlled , multicenter clinical study . Objective . To compare the safety and clinical and radiographic outcomes of OP-1 ( BMP-7 ) Putty to autogenous iliac crest bone graft in a population of patients undergoing laminectomy and posterolateral fusion for symptomatic lumbar stenosis associated with degenerative spondylolisthesis . Summary of Background Data . Although the existing pre clinical and clinical data suggest that OP-1 is able to achieve osteoinduction and clinical fusion in a variety of situations , the efficacy of this recombinant protein in a clinical spine fusion population has not been fully eluci date d. This study directly compares the efficacy and safety of OP-1 putty to autograft bone for arthrodesis in patients with symptomatic stenosis in association with degenerative spondylolisthesis . Methods . Thirty-six patients with degenerative lumbar spondylolisthesis and symptoms of neurogenic claudication underwent laminectomy , bilateral medial facetectomy , and posterolateral fusion using either iliac crest autograft or OP-1 Putty .  Oswestry scores and SF-36 question naires were used to determine the clinical response to treatment . Independent , blinded neuroradiologists review ed both static and dynamic radiographs to determine the fusion status . Successful fusion was declared whenthe presence of continuous bridging bone between the transverse processes was observed and less than 5 ° of angular motion and 2 mm of translational movement was measured using digital calipers . Results . Efficacy data were tabulated for 27 patients at the 24-month time point and an additional 4 patients ( without evaluable 24-month results ) at the 36-month time point . One patient was not evaluable for radiology , so the data reflect clinical information for 31 patients and radiology for 30 patients .  Clinical success , defined as a 20 % improvement in the preoperative Oswestry score , was achieved by 17 of 20 ( 85 % ) OP-1 Putty patients and 7 of 11 ( 64 % ) autograft patients . A successful posterolateral fusion was achieved in 11 of 20 ( 55 % ) OP-1 Putty patients and 4 of 10 ( 40 % ) autograft patients . SF-36 scores showed similar clinical improvement in both groups . No systemic toxicity , ectopic bone formation , recurrent stenosis , or other adverse events specifically related to the use of the OP-1 Putty implant were observed . Conclusion . This study represents the first clinical trial to demonstrate the safety and similarity of OP-1 Putty as a replacement for autogenous bone graft in the posterolateral fusion environment with a minimum of 2-year follow-up . OP-1 Putty was able to achieve osteoinduction leading to a radiographically solid fusion in the absence of autogenous iliac crest bone graft in 55 % of the patients at 24 and 36 months . These results compare favorably to the historical fusion rates reported for uninstrumented arthrodesis in this challenging clinical scenario Study Design . Prospect i ve multicenter r and omized clinical trail . Objective . The goal of our 2-year prospect i ve study was to perform a r and omized clinical trial comparing the outcomes of Grafton demineralized bone matrix ( DBM ) Matrix with local bone with that of iliac crest bone graft ( ICBG ) in a single-level instrumented posterior lumbar fusion . Summary of Background Data . There has been extensive research and development in identifying a suitable substitute to replace autologous ICBG that is associated with known morbidities . DBMs are a class of commercially available grafting agents that are prepared from allograft bone . Many such products have been commercially available for clinical use ; however , their efficacy for spine fusion has been mostly based on anecdotal evidence rather than r and omized controlled clinical trials . Methods . Forty-six patients were r and omly assigned ( 2:1 ) to receive Grafton DBM Matrix with local bone ( 30 patients ) or autologous ICBG ( 16 patients ) . The mean age was 64 ( females [ F ] = 21 , males [ M ] = 9 ) in the DBM group and 65 ( F = 9 , M = 5 ) in the ICBG group . An independent radiologist evaluated plain radiographs and computed tomographic scans at 6-month , 1-year , and 2-year time points . Clinical outcomes were measured using Oswestry Disability Index ( ODI ) and Medical Outcomes Study 36-Item Short Form Health Survey . Results . Forty-one patients ( DBM = 28 and ICBG = 13 ) completed the 2-year follow-up .  Final fusion rates were 86 % ( Grafton Matrix ) versus 92 % ( ICBG ) ( P = 1.0 not significant ) . The Grafton group showed slightly better improvement in ODI score than the ICBG group at the final 2-year follow-up ( Grafton [ 16.2 ] and ICBG [ 22.7 ] ) ; however , the difference was not statistically significant ( P = 0.2346 at 24 mo ) . Grafton showed consistently higher physical function scores at 24 months ; however , differences were not statistically significant ( P = 0.0823 ) . Similar improvements in the physical component summary scores were seen in both the Grafton and ICBG groups . There was a statistically significant greater mean intraoperative blood loss in the ICBG group than in the Grafton group ( P < 0.0031 ) . Conclusion . At 2-year follow-up , subjects who were r and omized to Grafton Matrix and local bone achieved an 86 % overall fusion rate and improvements in clinical outcomes that were comparable with those in the ICBG group Study Design . Prospect i ve r and omized controlled trial of rhBMP-2/ACS ( Infuse bone graft ) versus iliac crest bone graft ( ICBG ) for lumbar spine fusion in patients over 60 years of age . Objective . To report on clinical , radiographic , and economic outcomes , at 2-year follow-up , in patients treated by posterolateral lumbar fusion with rhBMP-2/ACS versus ICBG .  Summary of Background Data . RhBMP-2/ACS is widely used “ off-label ” for posterolateral spinal fusion . Despite encouraging initial reports , outst and ing issues include the need for evidence regarding safety and efficacy in an older population ; and an assessment of cost-effectiveness . Methods . Patients over 60 years old were r and omized to rhBMP-2/ACS ( n = 50 ) or ICBG ( n = 52 ) .  Oswestry Disability Index , Short Form-36 , and numerical rating scales for back and leg pain were determined preoperatively and at 6 , 12 , and 24 months postoperatively . Fusion was evaluated by fine-cut computed tomography scan 2 years postoperatively by 3 review ers . All in-patient and subsequent out-patient event costs were recorded by a dedicated hospital coder . Results . Two-year postoperative improvement in Oswestry Disability Index averaged 15.8 in the rhBMP-2/ACS group and 13.0 in the ICBG group . Mean improvement in Short Form-36 physical component score was 6.6 in the rhBMP-2/ACS group and 7.5 in the ICBG group . There were 20 complications in the ICBG group and 8 complications in the rhBMP-2/ACS group ( P = 0.014 ) . Sixteen ICBG and 10 rhBMP-2/ACS patients required additional treatment for persistent back or leg symptoms . Two rhBMP-2/ACS patients had revision procedures , 1 for nonunion . Eight patients in the ICBG group had revision procedures , 5 for nonunion . Mean fusion grade on computed tomography scan was significantly ( P = 0.030 ) better in the rhBMP-2/ACS ( 4.3 ) compared with the ICBG group ( 3.8 ) . Mean cost of the initial admission was $ 36,530 in the rhBMP-2/ACS group and $ 34,235 in the iliac crest bone graft ( ICBG ) group . Total cost of care over 2 years was $ 42,574 for the ICBG group and $ 40,131 for the rhBMP-2/ACS group . Conclusion . RhBMP-2/ACS is a viable ICBG replacement in older patients in terms of safety , clinical efficacy , and cost-effectiveness BACKGROUND CONTEXT Although autogenous bone is still considered to be the gold st and ard graft material for promoting spinal fusion , other bone graft substitutes have been developed in an attempt to improve arthrodesis rates and avoid the complications associated with the procurement of autograft . The bone morphogenetic proteins ( BMPs ) represent a family of osteoinductive growth factors that are known to stimulate the osteoblastic differentiation of stem cells . Osteogenic protein-1 ( OP-1 ) Putty is a commercially available BMP preparation that is already approved for use in humans . Previous clinical studies involving patients with degenerative spondylolisthesis have reported that the efficacy and safety of OP-1 Putty is comparable to that of autograft at both 1- and 2-year follow-up . PURPOSE The purpose of this study was to evaluate the intermediate-term efficacy and safety of OP-1 Putty as an alternative to autogenous bone by comparing the 4-year radiographic , clinical , and safety data of these same patients who underwent decompression and uninstrumented fusion with either OP-1 Putty or iliac crest autograft .  STUDY DESIGN / SETTING A prospect i ve , r and omized , controlled , multicenter clinical pilot study . PATIENT SAMPLE Thirty-six patients undergoing decompressive laminectomy and single-level uninstrumented fusion for degenerative spondylolisthesis and symptomatic spinal stenosis were r and omized in a 2:1 fashion to receive either OP-1 Putty ( 24 patients ) or autogenous iliac crest bone graft ( 12 patients ) . OUTCOME MEASURES Patient-reported outcome measures consisting of Oswestry Disability Index and Medical Outcomes Study 36-Item Short Form Health Survey ( SF-36 ) scores were used to evaluate clinical efficacy . Perioperative data including operative time , estimated blood loss , and duration of hospital stay were also recorded for each surgery . Postoperatively , a neurological examination and an assessment of donor-site pain ( if applicable ) were performed at every follow-up visit . Radiographic fusion success was defined as the presence of continuous bridging bone formation between the transverse processes at the level of the spondylolisthesis with minimal motion evident on dynamic lateral x-ray films . The primary efficacy endpoint was the overall success rate , a composite measure derived from both radiographic and clinical parameters . The safety of OP-1 Putty was confirmed by comparing the nature and frequency of all adverse events and complications that were prospect ively observed in either of the groups . METHODS Thirty-six patients with degenerative spondylolisthesis and symptoms of neurogenic claudication underwent decompressive laminectomy and single-level uninstrumented fusion with either OP-1 Putty or autograft . All patients were evaluated at 6 weeks and 3 , 6 , 9 , 12 , and 24 months , after which time they were instructed to return on a yearly basis . Multiple neuroradiologists blinded to the assigned treatment review ed static and dynamic X-ray films with digital calipers to assess fusion status according to the presence of continuous bridging bone across the transverse processes as well as the amount of residual motion evident at the level of interest . Oswestry Disability Index surveys and SF-36 question naires were used to assess clinical outcomes . RESULTS At the 48-month time point , complete radiographic and clinical data were available for 22 of 36 patients ( 16 OP-1 Putty and 6 autograft ) and 25 of 36 patients ( 18 OP-1 Putty and 7 autograft ) , respectively . Radiographic evidence of a solid arthrodesis was present in 11 of 16 OP-1 Putty patients ( 68.8 % ) and 3 of 6 autograft patients ( 50 % ) . Clinical ly successful outcomes defined as at least a 20 % improvement in preoperative Oswestry scores were experienced by 14 of 19 OP-1 Putty patients ( 73.7 % ) and 4 of 7 autograft patients ( 57.1 % ) ; these clinical findings were corroborated by similar increases in SF-36 scores . The respective overall success rates of the OP-1 Putty and autograft group were 62.5 % and 33.3 % . In this study , there were no incidents of local or systemic toxicity , ectopic bone production , or other adverse events directly 
    Output:
    