Demineralized bone matrix composite grafting for posterolateral spinal fusion. A prospective study of Autologous Growth Factors (AGF) in lumbar interbody fusion. Comparison of OP-1 Putty (rhBMP-7) to Iliac Crest Autograft for Posterolateral Lumbar Arthrodesis: A Minimum 2-Year Follow-up Pilot Study The safety and efficacy of OP-1 (rhBMP-7) as a replacement for iliac crest autograft for posterolateral lumbar arthrodesis: minimum 4-year follow-up of a pilot study. The perioperative cost of Infuse bone graft in posterolateral lumbar spine fusion. A pilot safety and efficacy study of OP-1 putty (rhBMP-7) as an adjunct to iliac crest autograft in posterolateral lumbar fusions Randomized Radiostereometric Study Comparing Osteogenic Protein-1 (BMP-7) and Autograft Bone in Human Noninstrumented Posterolateral Lumbar Fusion: 2002 Volvo Award in Clinical Studies Accelerating lumbar fusions by combining rhBMP-2 with allograft bone: a prospective analysis of interbody fusion rates and clinical outcomes. Initial Fusion Rates With Recombinant Human Bone Morphogenetic Protein-2/Compression Resistant Matrix and a Hydroxyapatite and Tricalcium Phosphate/Collagen Carrier in Posterolateral Spinal Fusion Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 16: bone graft extenders and substitutes. A 2-year follow-up pilot study evaluating the safety and efficacy of op-1 putty (rhbmp-7) as an adjunct to iliac crest autograft in posterolateral lumbar fusions Anterior Lumbar Interbody Fusion Using rhBMP-2 With Tapered Interbody Cages Avoidance of large biases and large random errors in the assessment of moderate treatment effects: the need for systematic overviews. Use of Recombinant Human Bone Morphogenetic Protein-2 as an Adjunct in Posterolateral Lumbar Spine Fusion: A Prospective CT-Scan Analysis at One and Two Years Role of Activated Growth Factors in Lumbar Spinal Fusions Clinical Outcomes and Fusion Success at 2 Years of Single-Level Instrumented Posterolateral Fusions With Recombinant Human Bone Morphogenetic Protein-2/Compression Resistant Matrix Versus Iliac Crest Bone Graft Two-Year Fusion Rate Equivalency Between Grafton® DBM Gel and Autograft in Posterolateral Spine Fusion: A Prospective Controlled Trial Employing a Side-by-Side Comparison in the Same Patient Use of rhBMP-2 in combination with structural cortical allografts: clinical and radiographic outcomes in anterior lumbar spinal surgery. The Use of rhBMP-2 in Interbody Fusion Cages: Definitive Evidence of Osteoinduction in Humans: A Preliminary Report Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages. A Prospective Randomized Study of Posterolateral Lumbar Fusion Using Osteogenic Protein-1 (OP-1) Versus Local Autograft With Ceramic Bone Substitute: Emphasis of Surgical Exploration and Histologic Assessment Platelet Gel (AGF) Fails to Increase Fusion Rates in Instrumented Posterolateral Fusions Graft Resorption With the Use of Bone Morphogenetic Protein: Lessons From Anterior Lumbar Interbody Fusion Using Femoral Ring Allografts and Recombinant Human Bone Morphogenetic Protein-2 Radiographic Assessment of Interbody Fusion Using Recombinant Human Bone Morphogenetic Protein Type 2 Clinical and Radiographic Outcomes of Anterior Lumbar Interbody Fusion Using Recombinant Human Bone Morphogenetic Protein-2 A Pilot Study Evaluating the Safety and Efficacy of OP-1 Putty (rhBMP-7) as a Replacement for Iliac Crest Autograft in Posterolateral Lumbar Arthrodesis for Degenerative Spondylolisthesis
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 BACKGROUND Numerous pre clinical and clinical studies have reported on the use of platelet concentrates to promote tissue healing . The results in spinal fusion applications are limited and controversial . PURPOSE The purpose of the current prospect i ve clinical cohort study is to assess the effect of Autologous Growth Factors ( AGF ) on lumbar interbody fusion with specific attention paid to determination of clinical and radiographic outcomes . STUDY DESIGN / SETTING Prospect i ve clinical study PATIENT SAMPLE C and i date s for anterior-posterior lumbar fusion with diagnosis of degenerative disc disease and /or up to grade I spondylolytic spondylolisthesis based on positive provocative discography . OUTCOME MEASURES Clinical ( visual analogue pain scale/functional outcome assessment ) and radiographic outcomes ( fusion on computed tomography at 6 months and plain radiographs at 12 and 24 months ) . METHODS Thirty-seven patients were assigned to st and ard anterior-posterior interbody fusion L2-S1 ( single or two-level ) using iliac crest bone graft ( autograft group : 22 patients with 32 levels operated ) or allograft combined with autogenous growth factors ( AGF group : 15 patients with 25 levels operated ) . Radiographic outcomes were collected at 6 months postsurgery with computed tomography and at 12 and 24 months with plain radiographs . Pre- and postoperative clinical outcome measures included visual analog scores ( VAS ) for back and leg pain ( 0 - 10 ) , SF-36 scores , and Oswestry disability determination . Average clinical and radiographic follow-up for the autograft group was 24.3+/-5.6 months ( 12 - 36 months ) and AGF was 25.7+/-7.5 ( 6 - 40 months ) . RESULTS Fusion incorporation at each end plate was determined at 56 % in both autograft and AGF ( p = NS ) patients based on computed tomography at 6 months with minimal subsidence noted and no direct correlation between the incidence or degree of cage subsidence and bone graft technique . The 12- and 24-month radiographic results confirmed an 85 % arthrodesis rate for the autograft patients , whereas the AGF patients had an 89 % fusion rate ( p = NS ) . Clinical outcomes were similar for both groups and no significant differences were noted for pain or functional outcome improvements . CONCLUSIONS AGF combined with an allograft carrier is equivalent in radiographic and clinical outcomes to autograft in one- or two-level lumbar interbody fusion with supplemental posterior fixation and , thus , eliminates any morbidity from iliac crest bone graft harvesting . AGF combined with an appropriate carrier is a reasonable alternative to autograft and expensive bone induction technologies . Further research is still required to examine the optimum carriers , preparation and formulation , and platelet concentrations for this technology 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 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 related to the use of OP-1 Putty . CONCLUSION Despite the challenges associated with obtaining a solid uninstrumented fusion in patients with degenerative spondylolisthesis , the rates of radiographic fusion , clinical improvement , and overall success associated with the use of OP-1 Putty were at least comparable to that of the autograft controls for at least 48 months after surgery . These results appear to vali date the short-term results previously reported for OP-1 Putty and suggest that this material may potentially represent a viable bone graft substitute for certain fusion applications BACKGROUND CONTEXT There is mounting evidence supporting the efficacy of bone morphogenetic protein ( BMP ) for both anterior interbody and posterolateral lumbar fusion . However , the relative cost of BMP remains an important concern for physicians , hospitals , and payers . PURPOSE The purpose of this study is to report on the perioperative costs for patients treated with rhBMP-2 as compared with an iliac crest bone graft ( ICBG ) supplemented with graft extenders .  STUDY DESIGN / SETTING A prospect i ve r and omized controlled trial of rhBMP-2/ACS ( Infuse Bone Graft ; Medtronic Sofamor Danek , Memphis , TN ) versus ICBG+/-graft extender for lumbar spine fusion in patients over 60 years old . PATIENT SAMPLE One hundred two patients over 60 years old who required a posterolateral lumbar spine fusion r and omized between receiving rhBMP-2/ACS or ICBG .  OUTCOME MEASURES All health-care costs over the first 3 months after surgery . METHODS As part of a prospect i ve r and omized trial of rhBMP-2/ACS versus ICBG+/-graft extender for lumbar spine fusion , all costs over the first 3 months after surgery were directly recorded by a dedicated coder funded by Norton Healthcare , Louisville , KY . A dedicated research nurse also followed all patients throughout their hospital stay and posthospitalization recovery to identify any adverse events or additional outpatient medical care . RESULTS Fifty patients received rhBMP-2/ACS and 52 underwent ICBG harvest . The mean hospital cost for the index admission was $ 24,736 for the rhBMP-2/ACS group and $ 21,138 for the ICBG group . Mean inpatient physician costs were $ 5,082 in the rhBMP-2/ACS group and $ 5,316 in the ICBG group . Costs associated with posthospital rehabilitation averaged $ 4,906 in the rhBMP-2/ACS group versus $ 6,820 in the ICBG group . Total payer expenditure for the 3-month perioperative period averaged $ 33,860 in the rhBMP-2/ACS group and $ 37,227 in the ICBG group . CONCLUSIONS The hospital carries the cost burden associated with the utilization of rhBMP-2/ACS . In contrast , the payer in a Diagnosis-Related Group ( DRG ) model achieves a net savings , based primarily on the decreased payment for inpatient rehabilitation , but also on decreased hospital reimbursement , physician costs , and other outpatient services The ability of bone morphogenetic proteins ( BMPs ) to induce bone formation has led to an increasing interest in the potential for their use in fusion surgery . The purpose of this multi-center clinical pilot study was to evaluate the safety of one such BMP — osteogenic protein 1 , in the form of OP-1 putty — combined with autograft for intertransverse process fusion of the lumbar spine in patients with symptomatic spinal stenosis and degenerative spondylolisthesis following spinal decompression . Twelve patients with spinal stenosis and degenerative lumbar spondylolisthesis underwent laminectomy and partial or complete medial facetectomy as required for decompression of the neural elements followed by intertransverse process fusion by placing iliac crest autograft and OP-1 putty between the decorticated transverse processes . No instrumentation was used . Patients were followed clinical ly using the Oswestry scale and radiographically using static and dynamic radiographs to assess their fusion status . Independent and blinded radiologists assessed the films for the presence of bridging bone between the transverse processes and measured translation and angulation on dynamic films using digital calipers . In addition to bridging bone , less than or equal to 5 ° of angular motion and less than or equal to 2 mm of translation were required to classify the patients as successfully fused , as per the definition of successful fusion provided by the FDA for use in clinical trials involving investigational devices to attain spinal fusion . Radiographic outcome was compared to a historical control ( autograft alone fusion without instrumentation for the treatment of degenerative spondylolisthesis ) . All adverse events were recorded prospect ively . The results showed 9 of the 12 patients ( 75 % ) obtained at least a 20 % improvement in their preoperative Oswestry score , while 6 of 11 patients ( 55 % ) with radiographic follow-up achieved a solid fusion by the criteria used in this study . Bridging bone on the anteroposterior film was observed in 10 of the 11 patients ( 91 % ) . No systemic toxicity , ectopic bone formation , recurrent stenosis or other adverse events related to the OP-1 putty implant were observed . A successful fusion was observed in slightly over half the patients in this study , using stringent criteria without adjunctive spinal instrumentation . This study did not demonstrate the superiority of OP-1 combined with autograft over an autograft alone historical control , in which the fusion rate was approximately 45 % . The lack of adverse events related to the OP-1 putty implant in this study is in agreement with other studies supporting the safety of bone morphogenetic proteins in spinal surgery Study Design . R and omized efficacy trial comparing two types of noninstrumented posterolateral fusion between L5 and S1 in patients with L5 spondylolysis and vertebral slip less than 50 % , as evaluated by radiostereometric analysis . Objective . To determine whether osteogenic protein-1 ( BMP-7 ) in the OP-1 Implant yields better stabilizing bony fusion than autograft bone . Summary of Background Data . Animal studies of osteoinductive proteins in noninstrumented posterolateral fusions have shown high fusion rates . No similar conclusive study on humans has been performed . Methods . For this study , 20 patients were r and omized to fusion with either OP-1 Implant or autograft bone from the iliac crest , 10 in each group . The patients were instructed to keep the trunk straight for 5 months after surgery with the aid of a soft lumbar brace . At surgery 0.8-mm metallic markers were positioned in L5 and the sacrum , enabling radiostereometric follow-up analysis during 1 year . The three-dimensional vertebral movements , as measured by radiostereometric analysis induced by positional change from supine posture to st and ing and sitting , were calculated with an accuracy of 0.5 to 0.7 mm and 0.5 ° to 2.0 ° . Conventional radiography was added . Results . No significant difference was noted between the radiostereometric and radiographic results of fusion with the OP-1 Implant and fusion with autograft bone . There was a significant relation between reduced vertebral movements and better bone formation . No adverse effects of the OP-1 Implant occurred . Persistent minor pain at the iliac crest was noticed in one patient . Conclusions . There was no significant difference between the two fusion versions . Thus , the OP-1 Implant did not yield better stabilizing bony fusion than autograft bone BACKGROUND CONTEXT Recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) is an osteoinductive protein approved for use in the anterior lumbar interspace . High fusion rates with rhBMP-2 have been reported with threaded interbody allograft dowels . There may be a clinical benefit for the patient by adding rhBMP-2 to the allograft . PURPOSE To compare the fusion rates and clinical outcomes of patients treated with allograft interbody fusions  with and without the addition of rhBMP-2 . STUDY DESIGN Prospect i ve consecutive patient enrollment with minimum 24-month follow-up . PATIENT SAMPLE Seventy-five patients with lumbar interbody fusions at 1 - 3 spinal segments . OUTCOMES MEASURES Clinical : Numerical Rating Scale ( NRS ) and Oswestry Disability Index ( ODI ) . Radiographic : X-ray and computed tomographic scan analysis using the Molinari-Bridwell fusion scale . METHODS Seventy-five patients scheduled for lumbar fusion were enrolled sequentially . Group 1 : 30 patients had anterior interbody allografts alone . Group 2 : 45 patients had anterior interbody allograft filled with rhBMP-2 . All cases had posterior pedicle screw instrumentation . A total of 165 surgical levels ( 62 allograft alone/103 allograft+BMP ) were included . Fusion data and clinical outcomes were collected for a minimum of 2 years after surgery . RESULTS Statistically higher fusion rates were observed in the patients with BMP at all time points compared with allograft alone . Group 2 ( + BMP ) fusion rates were 94 % , 100 % , and 100 % at 6 , 12 , and 24 months after surgery . Group 1 ( -BMP )  fusion rates were 66 % , 84 % , and 89 % at the same time intervals . Clinical outcomes were significantly improved in Group 2 compared with Group 1 at 6 months . There were no revisions ( 0 % ) in the BMP group and 4 revision fusion surgeries ( 13 % ) in the allograft group . No untoward effects were attributable to the rhBMP-2 . CONCLUSIONS Our study confirms the efficacy of an innovative lumbar fusion technique : an interbody femoral ring allograft , combined with an osteoinductive stimulant ( rhBMP-2 ) , protected by pedicle screws . This combination of a structural interbody allograft with rhBMP-2 eliminates the insult of iliac crest harvest , allows for reliable radiographic analysis , and results in successful fusion formation in 100 % of the cases in this study Study Design . Prospect i ve , r and omized , unblinded study of iliac crest bone graft ( ICBG ) versus recombinant human bone morphogenetic protein-2/compression resistant matrix (rhBMP-2/CRM)in a posterolateral instrumented fusion procedure . Objectives . Document initial radiographic characteristics , based on computed tomography , with rhBMP-2/CRM for posterolateral fusion at 6 and 12-month intervals . Summary of Background Data . As the acceptance of INFUSE bone graft as an ICBG replacement becomes more widespread , surgeons have begun to study applications for rhBMP-2 in posterior spinal fusion . Pre clinical studies have examined variables including carrier composition , rhBMP-2 concentration , and rhBMP-2 dose . Pilot studies have been performed with encouraging initial results . Methods . Patients with single level lumbar degenerative disease were enrolled in a r and omized study of ICBG versus rhBMP-2/CRM in a posterolateral instrumented fusion procedure . Computed tomography scans at 6 and 12 months were grade d as demonstrating no fusion ( grade 1 ) , partial or limited unilateral fusion ( grade 2 ) , partial or limited bilateral fusion ( grade 3 ) , solid unilateral fusion ( grade 4 ) , or solid bilateral fusion ( grade 5 ) . Results . At our institution , 74 patients ( 38 rhBMP-2/CRM  , 36 ICBG ) reached minimum 1-year follow-up and were included in this analysis . Mean fusion grade ( scale1–5 ) at 6 months after surgery was 4.35 in the rhBMP-2/CRM group versus 3.09 in the ICBG group ( P < 0.0001 ) . At 1 year after surgery mean fusion grade was 4.62 in the rhBMP-2/CRM group versus 3.77 in the ICBG group ( P < 0.0023 ) . Conclusions . These early results are encouraging and suggest a more rapid incorporation and development of the fusion mass with rhBMP-2/CRM than iliac crest autograft in a single level posterior instrumented fusion Despite the large volume of animal data regarding the use of synthetic bone graft substitutes or extenders , there are very few data regarding the use of these substances for fusion in lumbar degenerative disease . The best available data indicate that rhBMP-2 is a viable alternative to autograft bone for interbody fusion procedures . This same substance may also be a viable alternative to autograft for PLF ; however , definitive medical evidence is not yet available . There is little , if any , medical evidence to support the use of other biological agents at the present time . As promising new compounds are brought to market , well- design ed cohort studies and r and omized trials will be required to determine the actual usefulness of these compounds in clinical practice . It is important not to generalize the results obtained with one preparation or application to different preparations or applications . The use of synthetic calcium phosphate ceramics as graft extenders appears to be reasonable in certain situations . The medical evidence available regarding their use is limited and of poor quality . Further study will be required to establish their utility for use in spinal fusion The ability of bone morphogenetic proteins ( BMPs ) to induce bone formation has led to a multitude of investigations into their use as bone graft substitutes in spinal surgery . The purpose of this multi-center clinical pilot study was to evaluate the safety and efficacy of BMP-7 ( osteogenic protein 1 , OP-1 ) , in the form of a putty , combined with autograft for intertransverse process fusion of the lumbar spine in patients with symptomatic spinal stenosis and degenerative spondylolisthesis following spinal decompression . Twelve patients with spinal stenosis and degenerative lumbar spondylolisthesis underwent a laminectomy and partial or complete medial facetectomy as required for decompression of the neural elements , followed by an intertransverse process fusion by placing iliac crest autograft and OP-1 putty between the decorticated transverse processes . No instrumentation was used . Patients were followed clinical ly using the Oswestry scale and SF-36 outcome forms , and radiographically using static and dynamic radiographs to assess their fusion status over a 2-year period . Independent and blinded radiologists assessed the films for the presence of bridging bone between the transverse processes and measured translation and angulation on dynamic films using digital calipers . Radiographic outcome was compared to a historical control ( autograft alone fusion without instrumentation for the treatment of degenerative spondylolisthesis ) . All adverse events were recorded prospect ively . The results showed eight of the nine evaluable patients ( 89 % ) obtained at least a 20 % improvement in their preoperative Oswestry score , while five of ten patients ( 50 % ) with radiographic follow-up achieved a solid fusion by the criteria used in this study . Bridging bone on the anteroposterior film was observed in seven of the ten patients ( 70 % ) . No systemic toxicity , ectopic bone formation , recurrent stenosis or other adverse events related to the OP-1 putty implant were observed . A successful fusion was observed in slightly over half the patients in this study , using stringent criteria without adjunctive spinal instrumentation . This study did not demonstrate the statistical superiority of OP-1 combined with autograft over an autograft alone historical control , in which the fusion rate was 45 % . There were no adverse events related to the OP-1 putty implant in this study , which supports findings in other studies suggesting the safety of bone morphogenetic proteins in spinal surgery In a multicenter , prospect i ve , r and omized , nonblinded , 2-year study , 279 patients with degenerative lumbar disc disease were r and omly divided into two groups that underwent interbody fusion using two tapered threaded fusion cages . The investigational group ( 143 patients ) received rhBMP-2 on an absorbable collagen sponge , and a control group ( 136 patients ) received autogenous iliac crest bone graft . Plain radiographs and computed tomographic scans were used to evaluate fusion at 6 , 12 , and 24 months after surgery . Mean operative time ( 1.6 hours ) and blood loss ( 109.8 mL ) were less in the investigational rhBMP-2 group than in the autograft control group ( 2.0 hours and 153.1 mL ) . At 24 months the investigational group 's fusion rate ( 94.5 % ) remained higher than that of the control group ( 88.7 % ) . New bone formation occurred in all investigational patients . At all intervals , mean postoperative Oswestry , back pain , and leg pain scores and neurologic status improved in both treatment groups with similar outcomes . In the control group , eight adverse events related to the iliac crest graft harvest occurred ( 5.9 % ) , and at 24 months 32 % of patients reported graft site discomfort and 16 % were bothered by its appearance . Lumbar fusion using rhBMP-2 and a tapered titanium fusion cage can yield a solid union and eliminate the need for harvesting iliac crest bone graft In order to avoid selective biases and to minimize r and om errors , inference about the effects of treatment on serious endpoints needs to be based not on one , or a few , of the available trial results , but on a systematic overview of the totality of the evidence from all the relevant unconfounded r and omized trials . But , only where coverage of all , or nearly all , r and omized patients in all relevant trials ( or a reasonably unbiased sample of such trials ) can be assured , is a systematic overview of trials reasonably trustworthy , for then any selective biases are likely to be small in comparison with any moderate effects of treatment . Checks for the existence of such biases can best be conducted if reasonably detailed data are available from each trial . Future trials should take into account the results of any relevant overviews in their design , and should plan to obtain sufficient numbers of events to contribute substantially to such overviews . In many cases , this implies the need for r and omized trials that are much larger than is currently st and ard Introduction This study determines whether recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) ( 12 mg at the rate of 1.5 mg/mL ) delivered on an absorbable collagen sponge with an added bulking agent can increase posterolateral lumbar spine fusion success rates and decrease time for fusion with autogenous bone grafts . Method A prospect i ve , single institution , clinical case-matched , radiographic , cohort study was undertaken . A total of 52 patients underwent posterolateral lumbar arthrodesis with pedicle screw instrumentation .  The experimental group ( n=41 ) underwent placement of Iliac crest bone graft ( ICBG ) with InFUSE ( 12 mg/level at the rate of 1.5 mg/mL ) . The control group ( n=11 ) consisted of sex-matched patients , consecutively collected over the same time period with an instrumented posterolateral arthrodesis and ICBG placed in the intertransverse space . Outcome Measures Thin-cut ( 2 mm ) axial , coronal , and sagittal reconstructions were blindly evaluated for evidence of bridging bone and cortication of the fusion mass by 3 separate review ers . Fusions were grade d and an overall score was given to the quality of the fusion mass . Results Fifty patients ( ICBG alone n=11 ; ICBG/rhBMP-2 n=39 ) were available for CT evaluation at 2-year follow-up . An overall 97 % ( 68/70 levels ; Definite+Probably Fused ) fusion rate in the rhBMP-2 group was achieved as compared to the 77 % fusion rate ( 17/22 levels ) in the ICBG alone group ( P<0.05 ) . In the rhBMP-2 group , 92 % of the patients ( 36/39 patients ) received an overall excellent subjective fusion rating as compared to 27 % ( 3/11 ) in the control group ( P<0.05 ) . There was no computed tomographic evidence of soft-tissue ossification , dural ossification , or laminar bone regrowth in any patient . Conclusions The adjunctive use of rhBMP-2 and ICBG seems to be safe and results in significantly larger and more consistent posterolateral fusion masses Background The concentration of platelets into an activated growth factor ( AGF ) gel may stimulate graft consolidation into a fusion mass . Preoperative hemodilution and intraoperative clot activation may also reduce the overall blood loss . Consequently , the need for postoperative transfusions may also be reduced . Objective The objective of this work was to report our experience with AGF platelet gels in transforaminal lumbar interbody fusion ( TLIF ) procedures . Methods A consecutive series of patients between 1996 and 1999 undergoing one- and two-level TLIFs with AGF were compared with a consecutive series of TLIF patients who did not receive AGF . Sixty-two control subjects who did not receive  AGF  and 22 patients who received an AGF platelet gel were compared after 41 and 34 months of follow-up , respectively . Results On average , the AGF group required 18 minutes of additional preincision anesthesia ( P = 0.0001 ) . No statistical differences in the operative times , estimated blood loss , postoperative drainage , percentage of patients requiring a transfusion , or length of hospitalization were appreciated between the two groups . The 19 % decrease in the arthrodesis rate of the AGF group , as compared with the control group , did not reach statistical significance . Platelet counts from the AGF platelet concentrates demonstrated an average 3.5-fold increase compared with preoperative serum levels . Conclusions The theoretical benefits of AGF platelet gel technology were not clinical ly appreciated . The cost of implementing this technology may therefore outweigh its theoretical benefits Study Design . This is a prospect i ve , r and omized study comparing iliac crest bone graft to bone morphogenetic protein (BMP)/compression resistant matrix in instrumented posterolateral fusions for single-level lumbar degenerative disease . A higher recombinant human bone morphogenetic protein (rhBMP)-2 dose and a carrier specific for posterior spine applications were used . Objectives . As part of a Food and Drug Administration IDE study , clinical outcomes and fusion rates of single-level instrumented posterolateral fusions using iliac crest bone graft or BMP/compression resistant matrix were evaluated . Summary of Background Data . Although iliac crest graft is the gold st and ard for lumbar fusion , alternatives to obviate the morbidity of graft harvest have become available . R and omized clinical trials have demonstrated equivalent fusion rates and clinical outcomes with rhBMP-2 and a collagen sponge versus autograft in anterior lumbar fusions . A human pilot study using rhBMP-2 with biphasic calcium phosphate demonstrated similar results for posterolateral fusions . Methods . Demographic and perioperative data , Short Form 36 , Oswestry Low Back Pain Disability Index , and leg and back pain scores were determined before surgery , and 1.5 , 3 , 6 , 12 , and 24 months after surgery . Independent neuroradiologists ’ evaluation of fine-cut computerized tomography scans with reconstructions were obtained at 6 , 12 , and 24 months . Results . There were 98 subjects , 45 in the iliac crest bone graft group and 53 in the BMP/compression resistant matrix group . There were no significant differences for age , weight , sex , smoking , or previous surgery between the groups . The average operative time ( 2.9 hours ) and blood loss ( 465 cc ) in the iliac crest bone graft group was greater than in the BMP/compression resistant matrix group ( 2.4 hours and 273 cc ) . There were no significant differences in any outcome measure at all time intervals . The fusion rate was lower in the iliac crest bone graft group ( 73 % ) than in the BMP/compression resistant matrix group ( 88 % ) at P = 0.051 . Conclusion . There was significant improvement of Short Form 36 ( physical component score and pain ) , Oswestry Low Back Pain Disability Index , and leg and back pain scores in both groups over all time intervals . Surgical time and blood loss were significantly less in the BMP/compression resistant matrix group . The fusion rate in the BMP/compression resistant matrix group was significantly higher than the iliac crest bone graft group Study Design . Multicenter , prospect i ve equivalency trial with each patient serving as his/her own control . Objectives . To compare the effectiveness of a Grafton ® DBM gel composite with iliac crest autograft in posterolateral spine fusion . Summary of Background Data . While autograft remains the preferred graft material to facilitate spine fusion , the supply is limited and harvesting produces undesirable clinical consequences . Methods . A total of 120 patients underwent posterolateral spine fusion with pedicle screw fixation and bone grafting . Iliac crest autograft was implanted on one side of the spine and a Grafton ® DBM/autograft composite was implanted on the contralateral side in the same patient . An independent , blinded review er evaluated anteroposterior and lateral flexion-extension radiographs . The fusion mass lateral to the instrumentation on each side was judged fused or not , and the mineralization of the graft was rated absent , mild , moderate , or extensive . The degree of correspondence in outcomes between sides was estimated by computing the percentage agreement and kappa statistic . Results . Nearly 70 % of patients ( 81 of 120 ) provided complete 24-month radiographic studies . The bone graft mass was fused in 42 cases ( 52 % ) on the Grafton ® DBMside and in 44 cases ( 54 % ) on the autograft side . The overall percentage agreement for fusion status between sides was approximately 75 % ( 61 of 81 ) , indicating moderately strong statistical correspondence ( kappa = 0.51 , P < 0.0001 ) . Bone mineralization ratings also were similar between treated sides . Perfect agreement was realized in almost 60 % of patients ( 48 of 81 ) with moderate statistical correspondence ( weighted kappa = 0.54 , P < 0.0001 ) . Conclusions . Grafton ® DBM can extend a smaller quantity of autograft than is normally required to achieve a solid spinal arthrodesis . Consequently , a reduced amount of harvested autograft may be required , potentially diminishing the risk and severity of donor site complications BACKGROUND Recombinant human bone morphogenetic protein-2 soaked into an absorbable collagen sponge ( rhBMP-2/ACS ) has been shown in a nonhuman primate study and in a pilot study in humans to promote new bone formation and incorporation of an allograft device when implanted in patients undergoing anterior lumbar interbody arthrodesis . However , a larger series with longer follow-up is needed to demonstrate its superiority to autogenous iliac crest bone graft . METHODS Between 1998 and 2001 , a two-part , prospect i ve , r and omized , multicenter study of 131 patients was conducted to determine the safety and efficacy of the use of rhBMP-2/ACS as a replacement for autogenous iliac crest bone graft in anterior lumbar spinal arthrodesis with threaded cortical allograft dowels . Patients were r and omly assigned to a study group that received rhBMP-2/ACS or to a control group that received autograft . The clinical and radiographic outcomes were determined with use of well-established instruments and radiographic assessment s. RESULTS The patients in the study group had significantly better outcomes than the control group with regard to the average length of surgery ( p < 0.001 ) , blood loss ( p < 0.001 ) , and hospital stay ( p = 0.020 ) . Fusion rates were significantly better in the study group ( p < 0.001 ) . The average Oswestry Disability Index scores , Short-Form-36 physical component summary scores , and low-back and leg-pain scores were significantly better in the study group ( p < 0.05 ) . CONCLUSIONS In patients undergoing anterior lumbar interbody arthrodesis with threaded allograft cortical bone dowels , rhBMP-2/ACS was an effective replacement for autogenous bone graft and eliminated the morbidity associated with graft harvesting Study Design . A prospect i ve r and omized controlled human clinical pilot trial . Objectives . To determine the feasibility of using rhBMP-2/collagen as a substitute for autogenous bone graft inside interbody fusion cages to achieve arthrodesis in humans . Summary of Background Data . Pre clinical studies have shown rhBMP-2 to be an effective substitute for autogenous bone graft , but there are no studies to date documenting such efficacy for human spine fusion . Methods . Fourteen patients with single-level lumbar degenerative disc disease refractory to nonoperative management were r and omized to receive lumbar interbody arthrodesis with a tapered cylindrical threaded fusion cage filled with rhBMP-2/collagen sponge or autogenous iliac crest bone . Patients were evaluated with radiographs , sagittally reformatted computed tomography scans , and Short Form-36 and Oswestry outcome question naires . Results . All 11 patients who received rhBMP-2 were judged by three independent radiologists to have solid fusions ( at 6 , 12 , and 24 months postimplantation ) , whereas only 2 of the 3 control patients , who received the st and ard treatment of autogenous iliac crest bone , were deemed to be fused . The Oswestry Disability Question naire scores of the rhBMP-2 group improved sooner ( after 3 months ) than those of the autograft group , with both groups demonstrating similar improvement at 6 months . Short Form 36 scores continued to improve up to 24 months . Conclusion . The arthrodesis was found to occur more reliably in patients treated with rhBMP-2–filled fusion cages than in controls treated with autogenous bone graft , although the sample size was limited . There were no adverse events related to the rhBMP-2 treatment . This study is one of the first to show consistent and unequivocal osteoinduction by a recombinant growth factor inhumans BACKGROUND CONTEXT In a large series of human patients undergoing open anterior lumbar interbody fusion with a tapered titanium fusion cage , recombinant human bone morphogenetic protein type 2 ( rhBMP-2 ) on an absorbable collagen sponge carrier has been shown to decrease operative time and blood loss , to promote osteoinduction and fusion and to be a safe and effective substitute for iliac crest harvesting . PURPOSE The purpose of the study was to determine the clinical and radiographic outcomes in patients treated for single-level degenerative lumbar disc disease with a posterior interbody fusion , using st and -alone cylindrical threaded titanium fusion cages with either autogenous bone graft or rhBMP-2 and an absorbable collagen sponge carrier . STUDY DESIGN / SETTING A prospect i ve , r and omized , nonblinded , 2-year pilot study at 14 investigational sites . PATIENT SAMPLE Between March 1999 and December 1999 , 67 patients with symptomatic , single-level degenerative lumbar disc disease of at least 6 months ' duration underwent a single-level posterior lumbar interbody fusion using two paired cylindrical threaded titanium fusion devices . Patients were r and omly assigned to one of two groups : one ( n=34 patients ) received rhBMP-2 on a collagen sponge carrier ; the other ( n=33 patients ) autogenous iliac crest bone graft . OUTCOME MEASURES Clinical outcomes were measured using low back and leg pain numerical rating scales , the Short Form (SF)-36 , Oswestry Low Back Pain Disability Question naire and work status . Plain radiographs and computed tomographic scans were used to evaluate fusion at 6 , 12 and 24 months after surgery . METHODS In this prospect i ve nonblinded study , 67 patients were r and omly assigned to one of two groups who underwent interbody fusion using two cylindrical threaded fusion cages : the investigational group ( 34 patients ) , who received rhBMP-2 on an absorbable collagen sponge , and a control group ( 33 patients ) , who received autogenous iliac crest bone graft . Clinical data were collected and analyzed by a commercial entity . RESULTS The mean operative time and blood loss for the investigational rhBMP-2 group was 2.6 hours and 322.8 ml , respectively . For the autograft control group , these values were 3.0 hours and 372.7 ml . The differences were not significant . Although not statistically different , at 24 months , the investigational group 's fusion rate of 92.3 % was higher than the control 's at 77.8 % . At all postoperative intervals , the mean Oswestry , back and leg pain scores and physical components of the SF-36 improved in both treatment groups compared with preoperative scores , but no significant differences were found between groups . A statistically significant difference in the change in back pain was found at 24 months for the investigational group . In the control group , two adverse events related to harvesting of the iliac crest graft occurred in two patients ( 6.1 % ) . CONCLUSIONS This small multicenter , r and omized , nonblinded trial showed few statistically significant differences between the study groups . Both groups showed comparable improvements on outcome scores . Overall results show that the use of rhBMP-2 can eliminate the need for harvesting iliac crest graft and may be an equivalent replacement for autograft for use in successful posterior lumbar interbody fusions . Further studies of the use of rhBMP-2 in posterior lumbar interbody fusion cage procedures are needed Study Design . A prospect i ve , r and omized and controlled study . Objectives . To evaluate the osteoinductive property of Osteogenic Protein-1 ( OP-1 or BMP-7 ) and fusion rate in human instrumented posterolateral lumbar fusion through radiographic examination , surgical exploration , and histologic assessment . Summary of Background Data . The use of osteoinductive agents is a current topic in spinal fusion . Numerous pre clinical investigations have demonstrated efficacy of osteoinductive proteins in spinal fusion , but few human clinical studies have been reported . Methods . Nineteen patients with L3–L4 or L4–L5 degenerative spondylolisthesis underwent posterolateral lumbar fusion using pedicle screw instrumentation .  The patients were r and omized to receive either OP-1 Putty ( 3.5 mg OP-1/g of collagen matrix per side ) alone ( n = 9 ) , or local autograft with HA-TCP granules ( n = 10 ) . Fusion status was evaluated using plain radiography and CT scan . Radiographic fusion criteria included less than 5 ° of angular motion , less than 2 mm of translation , and evidence of bridging bone in the posterolateral lumbar area in which the graft material s were placed following decortication . After a minimum 1-year follow-up , the patients who showed radiographic evidence of fusion underwent instrumentation removal and surgical exploration of the fusion site . Biopsy specimens were taken from the fusion mass and evaluated histologically . Results . Radiographic fusion rate was 7 of 9 OP-1 patients and 9 of 10 control patients . Based on surgical exploration of these 16 patients , new bone formation was macroscopically observed in the posterolateral lumbar region in all cases ; however , solid fusion was observed in 4 of 7OP-1 and 7 of 9 HA-TCP/autograft patients . Histologic assessment demonstrated viable bone in 6 of 7 OP-1 patients . All the control ( HA-TCP/autograft ) specimens contained viable bone and fibrous tissue surrounding ceramic granules , suggesting slow incorporation of the graft material . Conclusions . In a human posterolateral lumbar spine trial , OP-1 reliably induced viable amounts of new bone formation , but the fusion success rate evaluated by surgical exploration was only 4 of 7 Study Design . Retrospective cohort study . Objective . To determine the effect on fusion of adding platelet gel to autologous iliac crest graft . Summary of Background Data . Platelet gel is an osteoinductive material prepared by ultra-concentration of platelets and contains multiple growth factors . Proprietary commercial methods are available for harvesting autologous platelet gel concentrates for use as graft supplement in spine fusions . Methods . We review ed 76 consecutive patients who underwent instrumented posterolateral lumbar fusion with autologous iliac crest bone graft mixed with autologous growth factor ( AGF ) . A control group was r and omly selected from patients who underwent instrumented posterolateral lumbar fusion with autologous bone graft alone .  The groups were matched for age , sex , smoking history , and number of levels fused . Demographic , surgical , and clinical data were collected from medical records . Diagnosis of nonunion was based on exploration during revision surgery or evidence of nonunion on computerized tomography . The Fisher exact test was used to compare fusion rates . Results . In both groups , mean age was 50 years , and 24 % were smokers . The nonunion rate was 25 % in the AGF group and 17 % in the control group . This difference was not statistically significant ( P = 0.18 ) . Conclusions . Platelet gel preparation requires blood draws from the patient . This procedure adds to the risk and cost of surgery . The technique for AGF harvest evaluated in this study provides the highest concentration of platelets among the commercially available methods . Despite this , we showed that platelet gel failed to enhance fusion rate when added to autograft in patients undergoing instrumented posterolateral spinal fusion . The authors do not recommend the use of platelet gel to supplement autologous bone graft during instrumented posterolateral spinal fusion Study Design . This is a prospect i ve cohort study examining the results and radiographic characteristics of anterior lumbar interbody fusion ( ALIF ) using femoral ring allografts ( FRAs ) and recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) . This was compared to a historical control ALIF using FRAs with autologous iliac crest bone graft ( ICBG ) . Objective . To determine whether the use of rhBMP-2 can enhance fusion ALIF with st and -alone FRAs . Summary of Background Data . ALIF is a well-accepted procedure in reconstructive spine surgery . Advances in spinal surgery have produced a multitude of anterior interbody implants . The rhBMP-2 has promoted fusion in patients undergoing ALIF with cages and threaded allograft dowels . The FRA still remains a traditional alternative for anterior support . However , as a st and -alone device , the FRA has fallen into disfavor because of high rates of pseudarthrosis . With the advent of rhBMP-2 , the FRA may be more attractive because of its simplicity and remodeling potential . It is important to underst and the implication s when rhBMP-2 is used with such structural allografts . Methods . A total of 36 consecutive patients who underwent ALIF with st and -alone FRAs by a single surgeon ( E.G.D. ) at 1 institute were included . A cohort of 9 consecutive patients who received FRAs filled with rhBMP-2 was followed prospect ively . After noticing suboptimal results , the senior author terminated this method of lumbar fusion . A total of 27 prior consecutive patients who received FRAs  filled with autogenous ICBG were used for comparison . Analyzing sequential radiographs , flexion-extension radiographs , and computerized tomography with multiplanar reconstructions determined nonunions . Minimum follow-up was 24 months . Results . Pseudarthrosis was identified in 10 of 27 ( 36 % ) patients who underwent st and -alone ALIF with FRAs and ICBG . Nonunion rate was higher among patients who received FRAs with rhBMP-2 ( i.e. , 5 of 9 [ 56 % ] ) . Statistical significance was not established because of the early termination of the treatment group ( P > 0.3 ) . Of interest , radiographs and computerized tomography revealed early and aggressive resorption of the FRAs when used with rhBMP-2 . This preceded graft fracture and even disintegration , result ing in instability and eventual nonunion . Conclusion . The use of rhBMP-2 did not enhance the fusion rate in st and -alone ALIF with FRAs . In fact , the trend was toward a higher nonunion rate with rhBMP-2 , although this was not significant with the numbers available . This result appears to be caused by the aggressive resorptive phase of allograft incorporation , which occurs before the osteoinduction phase Study Design . A prospect i ve r and omized study investigated the radiographic progress of fusion at 6 , 12 , and 24 months in 42 patients who underwent a single-level anterior lumbar interbody fusion using cylindrical interbody fusion cages . Objective . To determine the patterns and rates of osteoinduction associated with the use of recombinant human bone morphogenetic protein type 2 ( rhBMP-2 ) and an absorbable collagen sponge carrier in anterior lumbar interbody fusion with a tapered cylindrical fusion device . Summary of Background Data . Studies have shown that rhBMP-2 used with allograft dowels increases the rate of interbody fusion by promoting osteoinduction and enhancing incorporation of the allograft . In a small series of human patients undergoing anterior lumbar interbody fusion with a tapered cylindrical fusion cage , rhBMP-2 has been shown to promote osteoinduction and fusion . Methods . In this prospect i ve nonblinded study , 42 patients were r and omly divided into two groups . The investigational group underwent interbody fusion using two tapered cylindrical fusion cages ( LT – CAGE ) and rhBMP-2 on an absorbable collagen sponge , and a control group underwent the procedure , receiving the devices and autogenous iliac crest bone graft . Plain radiographs and computed tomographic scans were used to evaluate the pattern of osteoinduction in the interbody space and the progression of fusion 6 , 12 , and 24 months after surgery . Results . All the patients who received rhBMP-2 showed radiographic evidence of osteoinduction in the interbody cages 6 months after surgery . The density in the cages had increased an average of 142 Hounsfield units by 6 months . At 12 months , the increase had reached 228.7 Hounsfield units New bone formation occurred in the disc space outside the cages by 6 months in 18 of the patients in the investigational group ( 18/22 ; 82 % ) . By 24 months , all the investigational patients showed new formation outside the cages . In the autograft control group , the density in the cages increased an average of 42 Hounsfield units , and 10 patients ( 10/20 ; 50 % ) showed evidence of bone formation outside the cages . Conclusions . The use of rhBMP-2 is a promising method for facilitating anterior intervertebral spinal fusion in patients who have undergone anterior lumbar fusion surgery Study Design . A prospect i ve , nonblinded , multicenter study of outcomes in patients undergoing single-level anterior lumbar discectomy and interbody fusion with InFUSE ™ Bone Graft .  Objective . To determine the safety and effectiveness of InFUSE ™ Bone Graft applied to an absorbable collagen sponge in anterior lumbar interbody fusion with threaded cortical allografts . Summary of Background Data . In primates , InFUSE ™ Bone Graft used with allograft dowels was shown to increase rates of interbody fusion by promoting osteoinduction and enhancing incorporation of the allograft . Recently , in a small series of human patients undergoing anterior lumbar interbody fusion with a tapered cylindrical metal fusion cage , InFUSE ™ Bone Graft has been shown to promote osteoinduction and fusion . Methods . Forty-six patients underwent a single-level anterior lumbar discectomy and interbody fusion at five investigational sites . They were r and omly assigned to one of two groups , and the results in the investigational patients who received threaded cortical allograft dowels with InFUSE ™ Bone Graft were compared with those in the control patients who received threaded allograft dowels with autogenous iliac crest bone graft . Patients ’ clinical outcomes were assessed using neurologic status , work status , and Oswestry Low Back Pain Disability , Short Form-36 , and back and leg pain question naires . Anteroposterior , lateral , flexion-extension radiographs , and computed tomography scans were used to evaluate the progression of fusion at 6 , 12 , and 24 months after surgery . Results . All patients who received InFUSE ™ Bone Graft  showed radiographic evidence of bony induction and early incorporation of the cortical allografts . All patients in this group had fusions at 12 months that remained fused at 24 months . At 12 and 24 months , the investigational group showed higher rates of fusion and improved neurologic status and back and leg pain when compared with the control group . There were no unanticipated adverse events related to the use of InFUSE ™ Bone Graft . Conclusion . The use of InFUSE ™ Bone Graft is a promising method of facilitating anterior intervertebral spinal fusion , decreasing pain , and improving clinical outcomes in patients who have undergone anterior lumbar fusion surgery with structural threaded cortical allograft bone dowels Study Design . A prospect i ve , r and omized , controlled , multicenter clinical study was conducted . Objective . To compare the clinical and radiographic outcomes of patients treated with OP-1 ( BMP-7 ) Putty to autogenous iliac crest bone graft for one-level uninstrumented posterolateral fusion of the lumbar spine following decompressive laminectomy for the treatment of symptomatic degenerative spondylolisthesis with spinal stenosis . Background . Pre clinical studies have demonstrated that osteoinductive recombinant human osteogenic protein1 in the form of OP-1 Putty is successful at achieving a posterolateral fusion in rabbits and dogs without any significant safety concerns . Methods . Thirty-six patients with degenerative lumbar spondylolisthesis and symptoms of neurogenic claudication were r and omized ( 2:1 ) to either OP-1 Putty ( 3.5 mg of OP-1 per side ) or autogenous iliac crest bone graft for one-level uninstrumented posterolateral fusion following a decompressive laminectomy . Enrollment in the study was complete when 24 OP-1 Putty patients and 12 autograft patients had been r and omized and treated . A patient administered Oswestry scale and SF-36 scale were used to determine clinical outcomes . Independent , blinded neuroradiologists review ed both static and dynamic radiographs to determine fusion status . Results . At the 1-year follow-up , 32 patients were available for clinical analysis and 29 patients were available for radiographic review .  Clinical success as measured on the Oswestry scale was achieved by 18 of 21 ( 86 % ) OP-1 Putty patients and 8 of 11 ( 73 % ) autograft patients . SF-36 pain index scores showed similar results . Fourteen of 19 ( 74 % ) OP-1 Putty patients and 6 of 10 ( 60 % ) autograft patients achieved a successful posterolateral fusion fulfilling all fusion criteria . Of the 29 evaluable patients , 15 were both clinical and radiographic successes , 5 were radiographic successes but were clinical failures , 1 patient was both a radiographic and clinical failure , and 8 patients were radiographic failures but were clinical successes . No systemic toxicity , ectopic bone formation , recurrent stenosis , or other adverse events related to the OP-1 Putty implant were observed . Conclusion . Although the posterolateral spine is a challenging fusion environment in patients with degenerative spondylolisthesis , successful radiographic fusion was obtained using OP-1 Putty at a rate that was similar to autograft given the number of patients in this study . Importantly , there were no apparent adverse consequences related to the use of the OP-1 Putty implant in this patient population
OBJECT Autograft and allograft , the st and ard approaches for lumbar fusion procedures , have important disadvantages .
Bone graft substitutes such as recombinant human bone morphogenetic proteins ( rhBMP-2 and rhBMP-7 ) have emerged as viable alternatives .
The authors conducted a systematic review to compare the efficacy and safety of osteoinductive bone graft substitutes using autografts and allografts in lumbar fusion .