Radiographic Analysis of Fusion Mass Using Fresh Autologous Bone Marrow With Ceramic Composites as an Alternative to Autologous Bone Graft Comparative evaluation of bone–filled Polymethylmethacrylate implant, autograft fusion, and Polyetheretherketone cervical cage fusion for the treatment of single –level cervical disc disease. A preliminary comparative study of radiographic results using mineralized collagen and bone marrow aspirate versus autologous bone in the same patients undergoing posterior lumbar interbody fusion with instrumented posterolateral lumbar fusion. The Fusion Rate of Calcium Sulfate With Local Autograft Bone Compared With Autologous Iliac Bone Graft for Instrumented Short-Segment Spinal Fusion The First Clinical Trial of Beta-Calcium Pyrophosphate as a Novel Bone Graft Extender in Instrumented Posterolateral Lumbar Fusion Biocompatible Osteoconductive Polymer Versus Iliac Graft: A Prospective Comparative Study for the Evaluation of Fusion Pattern After Anterior Cervical Discectomy A Prospective Randomized Comparison of Coralline Hydroxyapatite With Autograft in Cervical Interbody Fusion A prospective consecutive study of instrumented posterolateral lumbar fusion using synthetic hydroxyapatite (Bongros-HA) as a bone graft extender. Comparative evaluation of microdiscectomy only, autograft fusion, polymethylmethacrylate interposition, and threaded titanium cage fusion for treatment of single-level cervical disc disease: a prospective randomized study in 125 patients. Healos graft carrier with bone marrow aspirate instead of allograft as adjunct to local autograft for posterolateral fusion in degenerative lumbar scoliosis: a minimum 2-year follow-up study. Short-Term Adverse Events, Length of Stay, and Readmission After Iliac Crest Bone Graft for Spinal Fusion GRADE guidelines: 3. Rating the quality of evidence. Single-Level Instrumented Posterolateral Fusion of Lumbar Spine With &bgr;-Tricalcium Phosphate Versus Autograft: A Prospective, Randomized Study With 3-Year Follow-up Efficacy of calcium sulfate plus decompression bone in lumbar and lumbosacral spinal fusion: preliminary results in 40 patients. Healos and Bone Marrow Aspirate Used for Lumbar Spine Fusion: A Case Controlled Study Comparing Healos With Autograft Correlative radiological, self-assessment and clinical analysis of evolution in instrumented dorsal and lateral fusion for degenerative lumbar spine disease. Autograft versus coralline hydroxyapatite A prospective comparative study of radiological outcomes after instrumented posterolateral fusion mass using autologous local bone or a mixture of beta-tcp and autologous local bone in the same patient Cage containing a biphasic calcium phosphate ceramic (Triosite) for the treatment of cervical spondylosis. Hydroxyapatite-Bioactive Glass Ceramic Composite as Stand-alone Graft Substitute for Posterolateral Fusion of Lumbar Spine: A Prospective, Matched, and Controlled Study Coralline hydroxyapatite and laminectomy-derived bone as adjuvant graft material for lumbar posterolateral fusion. Hybrid Grafting Using Bone Marrow Aspirate Combined With Porous &bgr;-Tricalcium Phosphate and Trephine Bone for Lumbar Posterolateral Spinal Fusion: A Prospective, Comparative Study Versus Local Bone Grafting A Comparison of Posterolateral Lumbar Fusion Comparing Autograft, Autogenous Laminectomy Bone With Bone Marrow Aspirate, and Calcium Sulphate With Bone Marrow Aspirate: A Prospective Randomized Study
Objective To determine whether a biphasic calcium phosphate ( BCP ) ceramic supplemented with fresh autologous bone marrow ( BMA ) can give rise to adequate bone to achieve a vertebral fusion mass . Material s and Methods A prospect i ve nonr and omized , radiographic study on 35 patients with posterolateral fusion using rigid transpedicular instrumentation for degenerative lumbar disease . At least 2-year follow-up . On the left side : autologous bone graft obtained from decompression . On the right side : a mixture of BCP and fresh autogenous bone marrow from the right iliac crest . Single-level fusion in 22 patients and two or more levels in 13 . Patients assessed with x-rays and computed tomography by an orthopedic surgeon and an independent radiologist .  Fusion mass was considered “ good ” when there was a continuous block of bone without radiolucent areas . No intersegmental bony bridging fusion was considered “ poor ” mass . McNemar , Fisher , and kappa tests were used for statistical analysis . Results The interobserver agreement ( κ ) had an average of 0.75 for the fusion masses . The interobserver average in the radiologic evaluation of ceramic resorption was 0.68 . No differences between smokers and nonsmokers were found . Plain radiography findings : good left fusion masses ( autologous bone ) in 31 patients and poor in 4 ; good right masses  ( BMA plus BCP ) in 31 patients and poor in 4 ( P>0.05 ) . Computed tomography evaluation : good left fusion masses in 28 patients and poor in 7 ; good right fusion masses in 31 patients and poor in 4 ( P>0.05 ) . One patient was reoperated , allowing biopsies to be performed : compact bone tissue was observed around hydroxyapatite in the right fusion mass . Conclusions The differences detected between right-side and left-side masses are not statistically significant . This indicates that , BMA and BCP , when mixed , behave like composite grafts and are able to generate sufficient bone mass for arthrodesis when a rigid instrumentation is used . However , a larger number of cases and longer follow-up are needed to generalize the indication Background : The objective of this study is to compare the clinical , functional , and radiological outcomes of using bone-filled Polymethylmethacrylate ( PMMA ) implant as an inexpensive alternative to Polyetheretherketone ( PEEK ) cage and Autologous bone graft ( ABG ) fusion after anterior cervical discectomy ( ACD ) for the treatment of single level cervical disc disease . Methods : 60 patients were prospect ively r and omized according to the material used for fusion after ACD into : 1 ) PMMA implant ; 2 ) ABG ; and 3 ) PEEK implant . The clinical outcomes were evaluated using Visual Analogue Scale ( VAS ) , whereas the functional outcomes were evaluated using Odom 's criteria . Radiological evaluations were also conducted using radiography and Computerized tomography ( CT ) scans and considered the following factors ; bony fusion , cervical stability and disc space height ( DSH ) changes . The post- operative outcomes were evaluated at the following intervals ; 2 weeks , 3 and 6 months . Results : The clinical outcomes demonstrated insignificant difference among the three treated groups throughout their follow up period . ABG group showed significant lower satisfactory functional outcomes ( 68.1 % ) compared to PMMA and PEEK groups ( 85 % and 88.9 % , respectively ) at the 2-week post operative evaluation , but the ABG group showed closer functional outcomes to the PMMA and PEEK groups at the 3 and 6-month post operative evaluations . Despite the inferior bony fusion rates of the PMMA group ( 30 % ) compared to ABG group ( 86.3 % ) and PEEK group ( 77.7 % ) at the 6-month post operative evaluation , the clinical and functional outcomes were comparable . Conclusions : Bone-filled PMMA implant is a reliable treatment option ; despite its inferior fusion rate at the 6-month postoperative evaluation , it still provides acceptable segmental stability , satisfactory clinical and functional outcomes that are comparable to ABG and PEEK grafting procedures BACKGROUND CONTEXT Multiple bone graft substitutes for spinal fusion have been studied with varying results . PURPOSE The purpose of this study was to assess the effectiveness of a mineralized collagen matrix combined with bone marrow , versus autologous bone , in the same patients undergoing a posterior lumbar interbody fusion and an instrumented posterolateral lumbar fusion . STUDY DESIGN / SETTING A prospect i ve , comparative study . PATIENT SAMPLE Patients indicated for one-level posterior lumbar interbody fusion and instrumented posterolateral lumbar fusion , serving as self-controls . OUTCOME MEASURES  Thin-cut computed tomographic scans with sagittal reconstruction and plain radiographs , including lateral flexion/extension views were performed and assessed at 12 and 24 months after surgery . Oswestry Disability Index and Visual Analog Scale question naires were completed by all patients preoperatively and at 12 and 24 months after surgery . METHODS After informed consent and failure of nonoperative treatment , 25 consecutive patients requiring one-level instrumented posterolateral fusion combined with posterior interbody fusion were enrolled in the study . Mineralized collagen bone graft substitute combined with bone marrow aspirate was used on one side of the posterolateral fusion , with iliac crest autograft on the contralateral side . RESULTS A fusion rate of 84 % ( 21/25 ) was achieved for the autologous bone grafts and 80 % ( 20/25 ) for the bone graft substitute . The interbody fusion rate was 92 % ( 23/25 ) . Mean Oswestry Disability Index ( ODI ) scores decreased 57.2 % at 12 months and 55.6 % at 24 months , compared with baseline . CONCLUSIONS Mineralized collagen bone graft substitute exhibited similar radiographic results compared with autograft in this model . Further trials incorporating bilateral fusion , as well as posterolateral fusion alone without interbody fusion are warranted to confirm the results of this study Study Design . A prospect i ve study . Objectives . To compare the efficacy of calcium sulfate pellets plus laminectomy bone chips with a fresh autologous iliac bone graft for short-segment lumbar fusion . Summary of Background Data . Bone graft substitute material can be used to exp and an existing quantity of available laminectomy bone chips . Methods . Seventy-four patients underwent surgery for instrumented one- or two-segment fusion with decompression .  Autologous iliac crest bone graft was placed in one posterolateral gutter , while on the other side , an equal quantity of autogenous laminectomy bone supplemented with calcium sulfate was placed .  Radiographic assessment included radiographs alone ; this was performed every 3 months ( 3 months to 12 months ) , then annually . The status of fusion and the relative size of the fusion bone mass on either side of the vertebra were compared . Results . Using iliac crest bone graft ( control side ) versus autograft laminectomy bone with calcium sulfate ( test side ) , there was no significant difference between the fusion rate and sizes of the fusion bone mass ( P > 0.05 ) . Follow-up periods ranged from 30 months to 34 months , averaging 32.5 months . For the 39 patients who received single-segment fusion , 34 patients ( 87.2 % ) exhibited bone fusion on the test side , and 35 patients ( 89.7 % ) had evidence of fusion on the control side . For the 35 patients who received two-segment fusion , 29 patients ( 82.9 % ) exhibited bone fusion on the test side and 30 patients ( 85.7 % ) demonstrated complete fusion on the control side . Conclusions . The fusion rate and fusion size between the two groups are similar . Calcium sulfate pellets may play a role as a bone graft extender in short-segment spinal fusion Background Porous β-calcium pyrophosphate ( β-CPP ) was developed to improve the fusion success of posterolateral lumbar fusion ( PLF ) . The possibility of accomplishing PLF using a mixture of porous β-CPP and iliac bone was studied . This paper reports the radiologic results of PLF using the β-CPP plus autograft for lumbar degenerative disease as a bone graft extender . Methods A prospect i ve , case-matched , radiographic study evaluating the results of short segment lumbar fusion using a β-CPP plus autograft was performed to compare the efficacy of β-CPP plus autograft with that of an autograft alone for short segment lumbar fusion . Thirty one consecutive patients ( 46 levels ) underwent posterolateral fusion with pedicle screw fixation and additional posterior lumbar interbody fusion .  In all patients , 3 mL of β-CPP plus 3 mL of autogenous bone graft was placed r and omly in one side of a posterolateral gutter , and 6 mL of autogenous iliac bone graft was placed on the other . The fusion rates , volumes of fusion masses , and bone absorption percentage were evaluated postoperatively using simple radiographs and 3 dimensional computed tomography ( 3D-CT ) scans . Results The control sides treated with an autograft showed significantly better Lenke scores than the study sides treated with β-CPP at 3 and 6 months postoperatively , but there was no difference between the two sides at 12 months . The fusion rates ( confirmed by 3D-CT ) were 87.0 % in the β-CPP group and 89.1 % in the autograft group , which were not significantly different . The fusion mass volumes and bone absorption percentage at 12 months postoperatively were 2.49 mL ( 58.4 % ) and 1.89 mL ( 69.5 % ) for the β-CPP and autograft groups , respectively , and mean fusion mass volume was significantly higher in the β-CPP group . Conclusions β-CPP combined with an autograft is as effective as autologous bone for grafting during instrumented posterolateral spinal fusion . These findings suggest that β-CPP bone chips can be used as a novel bone graft extender for short-segment posterolateral spinal fusion Study Design One hundred fifteen patients having symptomatic cervical disc disease were recruited prospect ively for this study . They were allocated r and omly for either autologous iliac bone graft or biocompatible osteoconductive polymer implants . Both groups were compared clinical ly and radiologically . Objectives Complications , long‐term clinical and radiologic outcome , and hospital stay were compared to determine if biocompatible osteoconductive polymer was an improvement on iliac bone graft in terms of reduced donor site pain and shortened hospital stay . Summary of Background Data Donor site morbidity is a significant problem in anterior cervical fusion . Hospital stay is another factor in the recent era of cost consciousness . Biocompatible osteoconductive polymer has been used in many centers as a biodegradable implant to circumvent these problems . Methods  Smith‐Robinson technique was used in 74 patients , and Cloward technique was used in 41 patients . Sixty‐five patients had biocompatible osteoconductive polymer implants , and 50 patients had iliac bone graft . Patients were followed‐up routinely in the outpatient clinic where pain visual analogue scale and Odom 's criteria were used for outcome evaluation . Plain radiography , computed tomography scan , and magnetic resonance imaging were used for radiologic evaluation . Results The mean hospital stay was 4.8 days for those with iliac bone graft and 4.7 days for those with biocompatible osteoconductive polymer . Clinical outcome was identical in both groups . The incidence of partial graft protrusion and postoperative intersegmental kyphosis was statistically higher with iliac bone graft ( P = 0.018 and P = 0.02 , respectively ) . “ Sclerosis ” started to form around biocompatible osteoconductive polymer like a “ halo ” at 2 months . It increased with time , and sometimes was associated with new osteophyte formation ; however , there was no biocompatible osteoconductive polymer incorporation or biodegradation . Conclusions Biocompatible osteoconductive polymer acts as a good “ spacer ” that reduces graft collapse and intersegmental kyphosis . However , it did not show any radiologic evidence of biodegradation or incorporation during the follow‐up period of 24 months Study Design . A prospect i ve r and omized trial with independent clinical and radiographic outcome review of patients receiving either hydroxyapatite or tricortical iliac crest graft for cervical interbody fusion was conducted . Objective . To determine whether coralline-derived hydroxyapatite is a suitable bone graft substitute in cervical interbody fusion . Summary of Background Data . Tricortical iliac crest bone is the “ gold st and ard ” graft material for cervical interbody fusion . Various bone substitutes have been used for this procedure to avoid potential donor site morbidity . ProOsteon 200 is a coralline-derived hydroxyapatite product , the use of which remains unclear for cervical interbody fusion . Methods . In this study , 29 patients undergoing anterior cervical fusion and plating were r and omized to receive either ProOsteon 200 or iliac crest grafts . The SF-36 and Oswestry Disability Index were used to measure clinical outcome . Postoperative radiographs were analyzed for graft fragmentation , loss of height , angular alignment , and hardware failure to assess structural integrity of the graft material . Plain radiographs and computed tomography scans were used to evaluate fusion . Results . Both the ProOsteon 200 and iliac crest groups demonstrated significant improvement in clinical outcome scores . There was no significant difference in clinical outcome or fusion rates between the two groups . Graft fragmentation occurred in 89 % of the hydroxyapatite grafts and 11 % of the autografts ( P = 0.001 ) . Significant graft settling occurred in 50 % of the hydroxyapatite grafts , as compared with 11 % of the autografts ( P = 0 . 009 ) . One patient in the ProOsteon 200 group required revision surgery for graft failure . Conclusions . ProOsteon 200 does not possess adequate structural integrity to resist axial loading and maintain disc height or segmental lordosis during cervical interbody fusion A prospect i ve , single institution , clinical case-matched , radiographic study was undertaken . Thirty-two patients underwent posterior lumbar interbody fusion with cages containing laminectomized bone chips and posterolateral lumbar fusion with pedicle screws . Autogenous bone graft ( 3 mL ) plus 3 mL of hydroxyapatite was placed in one side of a posterolateral gutter , and 6 mL of autogenous iliac bone graft was placed on the other side . Bony union , volumes of fusion mass , and bone absorption rates were postoperatively evaluated using simple radiographs and 3D-CT scans . Average postoperative Lenke scores at 3 and 6 months in the hydroxyapatite group were statistically higher than in the autograft group , but at 12 months no difference was found between the hydroxyapatite and autograft groups in terms of fusion rate . Complete fusion rates by 3D-CT were 86.7 % in the hydroxyapatite group and 88.9 % in the autograft group , which are not significantly different . Volumes of fusion mass and bone absorption rates at 12 months were 2.35 mL in the hydroxyapatite group and 1.31 mL in the autograft group . The mean fusion mass volume was greater in the hydroxyapatite group than in the autograft group . Lumbar posterolateral fusion using a mixture of hydroxyapatite artificial bone and autogenous bone graft showed good bony union similar to that shown with autogenous bone only . This study suggests that hydroxyapatite bone chips could be used usefully as a bone-graft extender in short-segment posterolateral spinal fusion OBJECT The need for interbody fusion or stabilization after anterior cervical microdiscectomy is still debated . The objectives of this prospect i ve r and omized study were 1 ) to examine whether combined interbody fusion and stabilization is more beneficial than microdiscectomy only ( MDO ) and 2 ) if fusion is found to be more beneficial than MDO , to determine which is the best method of fusion by comparing the results achieved using autologous bone graft ( ABG ) , polymethylmethacrylate ( PMMA ) interposition , and threaded titanium cage ( TTC ) . METHODS A total of 125 patients with a single-level cervical disc disease were included in this prospect i ve study . All patients were r and omized and assigned to one of the four following groups : Group 1 ( 33 patients ) , MDO ; Group 2 ( 30 patients ) , microdiscectomy followed by ABG ; Group 3 ( 26 patients ) , microdiscectomy followed by injection of PMMA ; and Group 4 ( 36 patients ) , microdiscectomy followed by placement of a TTC .  Clinical outcome according to Odom criteria was summarized as 1 ) excellent and good or 2 ) satisfactory and poor . One-year follow-up examination was performed in 123 patients . Patients in the TTC group experienced a significantly better outcome 6 months after surgery ( 92 % excellent and good results ) compared with those in the MDO and ABG groups ( 72.7 and 66.6 % excellent and good results , respectively ) . Twelve months after surgery there was still a significant difference in outcomes between the TTC group ( 94.4 % excellent and good results ) and the MDO group ( 75.5 % excellent and good results ) . Outcome in patients treated with PMMA was comparable with that in those treated with TCC after 6 ( 91.6 % ) and 12 months ( 87.5 % ) , but no segmental fusion was achieved . Differences compared with MDO and ABG were , however , not significant , which may be related to the smaller number of patients in the PMMA group . CONCLUSIONS Interbody cage-assisted fusion yields a significantly better short- and intermediate-term outcome than MDO in terms of return to work , radicular pain , Odom criteria , and earlier fusion . In addition , the advantages of interbody cages over ABG fusion included better results in terms of return to work , Odom criteria , and earlier fusion after 6 months . These results suggest that interbody cage-assisted fusion is a promising therapeutic option in patients with single-level disc disease . Polymethylmethacrylate seems to be a good alternative to interbody cage fusion but is hindered by the absence of immediate fusion OBJECT The objective of this study was to examine the efficacy and safety of Healos graft carrier with bone marrow aspirate and local autograft compared with the results of allograft in patients with lumbar degenerative scoliosis undergoing posterolateral fusion . METHODS Twenty-eight patients with degenerative scoliosis underwent posterolateral instrumented fusion and decompression . Patients were grouped according to the graft used . Group A consisted of 12 cases in which the authors used a Healos graft carrier , bone marrow aspirate , and local autograft , and Group B consisted of 16 cases in which the authors used cancellous allograft and local autograft . Patients were followed for a minimum of 2 years postoperatively in terms of pain ( visual analog scale ) , function ( Oswestry Disability Index ) , curve magnitude ( Cobb angle ) , and fusion status ( plain and dynamic radiographs ) . The 2 groups did not differ statistically significantly ( p > 0.05 ) in age , sex , smoking habits , magnitude of preoperative visual analog scale score , Oswestry Disability Index score , Cobb angle , or number of levels requiring decompression and fusion . RESULTS The groups had similar ( p > 0.05 ) results in terms of pain , function , curve progression , and fusion rates at the 2-year follow-up examination . Radiographic fusion was achieved in all but 2 cases , 1 in each group , in which the patients were asymptomatic . Patients in the allograft group ( Group B ) showed evidence of fusion earlier than in the Healos group ( p < 0.05 ) . No toxicity from  Healos graft was recorded . CONCLUSIONS The combination of Healos hydroxyapatite sponge and bone marrow aspirate plus local allograft had significantly slower fusion rates but equal clinical outcomes compared with cancellous allograft plus local autograft when used for posterolateral fusion in patients with degenerative lumbar scoliosis Study Design . Retrospective cohort study of 13,927 patients , 820 of whom received iliac crest bone graft ( ICBG ) .  Objective . To compare adverse events , length of stay ( LOS ) , and readmission for patients receiving ICBG with those who did not using multivariate analysis to control for potentially confounding factors . Summary of Background Data . The use of ICBG in spinal fusion has been associated with increased surgical time , LOS , and donor site morbidity . Development of expensive bone graft substitutes has been predicated on these issues . Data on the effect of bone graft harvest on LOS and readmission rate are sparse , and multivariate analysis has not been used to control for confounding factors . Methods . Prospect ively collected data from the American College of Surgeons National Surgical Quality Improvement Project 2010–2012 data base were retrospectively review ed . This includes demographics , comorbidities , surgical data , and hospital and 30-day follow-up outcomes data including adverse events , LOS , and readmission . Results . Only 5.9 % of spinal fusions use ICBG . Bivariate logistic regression ( used for categorical variables ) found the ICBG cohort was more likely to have a postoperative blood transfusion ( 11.6 % vs. 5.5 % , P < 0.001 ) . Bivariate linear regression ( used for continuous variables ) found the ICBG cohort to have an extended operative time ( + 36.0 min , P < 0.001 ) and extended LOS ( + 0.6 d , P < 0.001 ) . Multivariate analyses controlling for comorbidities , demographics , and approach-determined postoperative blood transfusion ( odds ratio , 1.5 ) , extended operative time ( + 22.0 min , P < 0.001 ) , and LOS ( + 0.2 d , P = 0.037 ) to be significantly associated with ICBG use . No other adverse event was significantly associated with ICBG use . Readmission rates were not significantly different . Conclusion . This study used a large national data base cohort and identified increased postoperative blood transfusion , extended operative time , and increased LOS as short-term outcomes associated with ICBG on multivariate analysis . Other short-term morbidities were not significantly associated with ICBG .  Readmission rates were not affected . Level of Evidence : This article introduces the approach of GRADE to rating  quality of evidence .  GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence Study Design . A prospect i ve , r and omized clinical study comparing & bgr;-tricalcium phosphate ( & bgr;-TCP ) with autograft bone graft with follow-up of 3 years . Objective . To determine the efficacy of & bgr;-TCP as a bone graft substitute combined with local autograft obtained from decompression compared with the use of autologous iliac crest bone graft in single-level instrumented posterolateral lumbar fusion . Summary of Background Data . A variety of bone graft substitutes have been used in posterolateral lumbar fusion with different efficacy reported , but no controlled study was conducted on the clinical performance of & bgr;-TCP in instrumented posterolateral lumbar fusion . Methods . Sixty-two patients with symptomatic degenerative lumbar spinal stenosis were treated with single-level instrumented posterolateral lumbar fusion . They were r and omly assigned to fusion with & bgr;-TCP combined with local bone obtained from the decompression ( group A , n = 32 ) or autogenous iliac crest bone graft plus decompression bone ( group B , n = 30 ) . The patients were observed up for 3 years after surgery . The results were assessed clinical ly and radiographically . Results . There were no significant differences in recovery rate of Japanese Orthopedic Association score and SF-36 score at all time intervals . Successful radiographic fusion was documented in all patients in both treatment groups . All patients in group B , however , complained bone graft donor site pain although significant improvement of pain was observed during the follow-up . Conclusion . Instrumented posterolateral fusion with & bgr;-TCP combined with local autograft results in the same radiographic fusion rates and similar improvement of clinical outcomes and life quality compared with autograft alone . The authors therefore recommend the use of & bgr;-TCP as bone graft substitute for instrumented posterolateral fusion of lumbar spine to eliminate the need of bone grafting harvesting from the ilium OBJECTIVE To compare the efficacy of calcium sulfate pellets plus bone obtained from decompression with fresh autologous iliac crest bone in lumbar and lumbosacral spinal fusion with decompression . DESIGN A prospect i ve r and omized clinical trial . SETTING Four tertiary care centres in Halifax , NS . PATIENTS All were consenting , skeletally mature and suffering from degenerative disc disease or spondylolisthesis . The first 40 patients from a single test centre are reported ; 32 of these had completed 1-year follow-up . INTERVENTIONS Posterolateral lumbar or lumbosacral spinal fusion with spinal canal decompression and r and omized placement of test material ( decompression bone plus an equal volume of calcium sulfate pellets ) on one side and control material ( autologous posterior iliac crest bone of equal volume to the test material ) on the contralateral side , which allowed subjects to act as their own control . OUTCOME MEASURES Assessment of bone formation by radiographic evaluation at 6 and 12 months after fusion by an independent musculoskeletal radiologist blinded to the placement of test material . RESULTS At 6 and 12 months after fusion , 78 % and 88 % of patients , respectively , showed bone formation at the test site that was 75 % to 100 % of , equal to or more than that at the control site . Increases in bone formation at 6 and 12 months were almost identical at both sites . Smoking status , patient gender or age , instrumentation used and volume of graft used were not predictive of outcome . CONCLUSIONS Calcium sulfate pellets plus decompression bone provided bone formation equivalent to autologous iliac crest bone in a majority of patients . Calcium sulfate pellets plus decompression bone may provide a viable alternative to autologous iliac crest as a graft material for spinal fusion Study Design . A prospect i ve case controlled study to compare the clinical and radiographic performance of Healos soaked in bone marrow aspirate ( BMA ) to iliac crest autograft when used in lumbar spinal fusion . Objective . To evaluate the null hypothesis : Healos used with BMA is not an effective alternative to iliac crest autograft in lumbar spine fusions . Summary of Background Data . Healos ( a Type 1 collagen/hydroxyapatite matrix ) is osteoconductive and when soaked for at least 20 minutes in BMA becomes osteoinductive . It is nontoxic and straightforward to use , avoiding the morbidity of autograft harvest . Animal studies and early clinical series in humans have suggested that Healos and BMA are an effective substitute for autograft in certain circumstances . Methods . From July 2000 , Healos and BMA were used as the graft material , instead of autograft harvested from the iliac crest , in all patients undergoing lumbar spinal fusion . Clinical outcome measures used were the Low Back Outcome Score ( LBOS ) , a Patient Satisfaction Score , and the Prolo Economic Score ( after Schnee ) . St and ing anteroposterior and lateral radiographs were taken at 12- and 24-month follow-up visits . The first 50 cases in this consecutive series were age , sex , and operative intervention matched to historical controls who underwent surgery between 1997 and 2000 and in whom autograft from the iliac crest had been used as the graft material . Surgical outcome data in these patients had also been gathered prospect ively . An independent radiologist , blinded to the graft material , using st and ard plain radiograph criteria for fusion , examined all the radiographs . An independent surgeon assessed clinical outcomes . Results . For posterolateral lumbar fusions , there were equivalent radiologic fusion rates for the 2 groups with no significant difference in the subjective and objective clinical outcomes . The radiologic fusions rate was significantly lower when Healos had been used for lumbar interbody fusions . Clinical outcomes for both groups were similar . There were no lasting complications associated with Healos use compared with a 14 % ; persisting donor site complication rate in the autograft patients . Conclusion . The null hypothesis is only partially correct . Healos and BMA are not inferior to autologous iliac crest bone as a graft material in posterolateral lumbar spine fusions but are radiographically ineffective in lumbar interbody fusions This prospect i ve longitudinal r and omized clinical and radiological study compared the evolution of instrumented posterolateral lumbar and lumbosacral fusion using either coralline hydroxyapatite ( CH ) , or iliac bone graft ( IBG ) or both in three comparable groups , A , B and C , which included 19 , 18 and 20 patients , respectively , who suffered from symptomatic degenerative lumbar spinal stenosis and underwent decompression and fusion . The patients were divided r and omly according to the graft used and the side that it was applied . The spines of group A received autologous IBG bilaterally ; group B , IBG on the left side and hydroxyapatite mixed with local bone and bone marrow on the right side ; group C , hydroxyapatite mixed with local bone and bone marrow bilaterally .  The age of the patients in the groups A , B and C was 61±11 years , 64±8 years and 58±8 years , respectively .  The SF-36 , Oswestry Disability Index ( ODI ) , and Rol and -Morris ( R-M ) surveys were used for subjective evaluation of the result of the surgery and the Visual Analogue Scale ( VAS ) for pain severity . Plain roentgenograms including anteroposterior , lateral and oblique views , and lateral plus frontal bending views of the instrumented spine and CT scan were used to evaluate the evolution of the posterolateral fusion in all groups and sides . Two independent senior orthopaedic radiologists were asked to evaluate first the evolution of the dorsolateral bony fusion 3–48 months postoperatively with the Christiansen ’s radiologic method , and secondly the hydroxyapatite resorption course in the spines of groups B and C. The diagnosis of solid spinal fusion was definitively confirmed with the addition of the bending views , CT scans and self- assessment scores . The intraobserver and interobserver agreement ( r ) for radiological fusion was 0.71 and 0.69 , respectively , and 0.83 and 0.76 for evaluation of CH resorption . T12−S1 lordosis and segmental angulation did not change postoperatively . There was no radiological evidence for non-union on the plain roentgenograms and CT scans . Radiological fusion was achieved 1 year postoperatively and was observed in all groups and vertebral segments . Six months postoperatively there was an obvious resorption of hydroxyapatite granules at the intertransverse intersegmental spaces in the right side of the spines of group B and both sides of group C. The resorption of hydroxyapatite was completed 1 year postoperatively . Bone bridging started in the third month postoperatively in all instrumented spines and all levels posteriorly as well as between the transverse processes in the spines of the group A and on the left side of the spines of group B where IBG was applied . SF-36 , ODI , and R-M score improved postoperatively in a similar way in all groups . There was one pedicle screw breakage at the lowermost instrumented level in group A and two in group C without radiologically visible pseudarthrosis , which were considered as having non-union . Operative time and blood loss were less in the patients of group C , while donor site complaints were observed in the patients of the groups A and B only . This study showed that autologous IBG remains the “ gold st and ard ” for achieving solid posterior instrumented lumbar fusion , to which each new graft should be compared . The incorporation of coralline hydroxyapatite mixed with local bone and bone marrow needs adequate bleeding bone surface . Subsequently , hydroxyapatite was proven in this series to not be appropriate for intertransverse posterolateral fusion , because the host bone in this area is little . However , the use of hydroxyapatite over the decorticated laminae that represents a wide host area was followed by solid dorsal fusion within the expected time Background We previously reported a retrospective analysis of radiographic changes in instrumented posterolateral fusion mass ( PLF ) established using a mixture of local autologous bone and beta tricalcium phosphate ( b-TCP ) in lumbar spinal fusion surgery . Here , we report a prospect i ve study to compare the use of local bone and a mixture of local bone and b-TCP in PLF in degenerative spinal surgery . Methods Radiological changes in the PLF mass in 42 patients were analyzed for 12 months . All patients had degenerative lumbar spinal disease and underwent instrumented fusion .  Local autologous bone was used for PLF on the left side , and a mixture of local autologous bone and b-TCP was used for PLF on the right side . Lumbar spinal anterior-posterior ( AP ) images were performed immediately postoperative and at 1 , 3 , 6 , and 12 months . Computed tomography ( CT ) was also done immediately postoperative and at 12 months . Fusion rate , radiodensity , and the dimensions of the PLF mass bilaterally on the AP X-ray were compared . The change in volume in both fusion bridges in the CT image was also compared . Results The overall fusion rates were 31/42 ( 73.8 % ) and 24/42 ( 57.1 % ) on the left and right sides , respectively . The decrease in radiodensity at 1 month postoperative was significantly greater on the left side than on the right side ( from 0.79 to 0.74 versus from 0.81 to 0.78 ; p = 0.002 ) . The mean immediate postoperative volume on the left side measured with CT was 5.1 cc ( 95 % CI , 4.94–5.34 ) and on the right side was 5.2 cc ( 95 % CI , 4.97–5.37 ) . The mean volume at 12 months had decreased to 2.2 cc ( 95 % CI , 1.85–2.64 ) on the left side and 1.87 cc ( 95 % CI , 1.48–2.67 ) on the right side . The volume decrease on the right side was statistically greater than on the left side ( p = 0.048 ) . Conclusions Based on the changes in radiodensity and fusion rate during follow-up , local bone seems to undergo earlier resorption and stabilization than the mixture of local bone and b-TCP BACKGROUND We evaluated the fusion efficacy and clinical outcomes of a cage containing a biphasic calcium phosphate ceramic ( Triosite ) in treating cervical spondylosis . METHODS We r and omly divided 100 patients with cervical spondylosis undergoing anterior discectomy with interbody polyetheretherketone ( PEEK ) fusion into 2 groups in the past 2 years : group A ( n = 50 ) , PEEK cage containing a biphasic calcium phosphate ceramic ( Triosite ) , and group B ( n = 50 ) , PEEK cage containing an autogenous iliac bone graft . We compared the fusion rate , fusion time , spinal curvature , and neuroforamen size between the 2 groups . We also compared excess operation time , excess blood loss , hospital stay , complications , and neurological recovery status between the groups . RESULTS The fusion rates were 57 % , 67 % , 77 % , 82 % , 92 % , and 100 % in group A and 81 % , 86 % , 95 % , 95 % 100 % , and 100 % in group B in the first 6 postoperative months . The fusion rate in group A was significantly lower than that in group B in the first 5 months after the procedure ( P < .05 and P < .01 , respectively ) , but the fusion rate reached 100 % in both groups by the sixth month . Within the first 6 months , as the fusion level increased , the fusion rates reduced and time to fusion was delayed in both groups . There were no donor site complications in group A. However , 3 patients ( 6 % ) from group B experienced complications ( 1 , wound infection ; 1 , numbness of thigh ; and 1 , subcutaneous hematoma ) ( P < .001 ) . The hospital stay was shorter in group A ( 4.43 + /- 2.36 days ) than in group B ( 7.00 + /- 3.77 days ) ( P = .001 ) . The mean excessive blood loss and excessive operative time for an iliac bone graft in group B were 15 + /- 5 mL and 10 + /- 6 minutes . There was no statistical significance in spinal curve correction , neuroforamen enlargement , and neurological recovery . CONCLUSIONS A cage containing a biphasic calcium phosphate ceramic result ed in complete fusion by the sixth postoperative month , although the fusion rate was lower than that in a cage containing an autograft during the first 5 months after the operation and the time to fusion was delayed . Using a cage containing a biphasic calcium phosphate ceramic leads to a shorter hospital stay , less blood loss , shorter operative time , and no donor site complications . It seemed to be a good substitute for cervical spondylotic fusion Study Design Prospect i ve , matched , and controlled study . Objective To evaluate the efficacy of hydroxyapatite-bioactive glass ceramic composite ( Chitra-HABg ) as a st and -alone graft substitute in promoting posterolateral fusion in the lumbar spine as compared with autologous bone . Background The use of ceramics as st and -alone graft substitutes in posterolateral fusion remains controversial . The Chitra-HABg is a new composite that has undergone clinical trials in various orthopedic applications with excellent clinical and radiologic outcomes . Methods Twenty-four patients underwent instrumented posterolateral fusion , with Chitra-HABg laid on the left intertransverse bed and autogenous graft on the right side . The primary outcome measure was radiologic consolidation of the graft , and secondary outcome measures were the work status and the Modified Oswestry Disability index . The McNamara and Student χ2 test were applied for statistical analysis . Results Although the study was prematurely terminated owing to the high incidence of resorption of Chitra-HABg , 22 of the 24 subjects were followed-up for a minimum of 1 year . At the end of 1-year , excellent radiologic outcome was seen on the right side ( autogenous graft ) in all the cases , whereas 95 % ( 21/22 ) of the cases had poor consolidation on the left side ( Chitra-HABg ) . The clinical outcome was rated as good in 16/22 ( 73 % ) patients , fair in 5 , and poor in only 1 patient , but this had no statistically significant association with the consolidation of the fusion mass . Conclusions This study clearly demonstrates that hydroxyapatite-bioactive glass ceramic composites ( Chitra-HABg ) has no role as st and -alone bone graft substitutes in posterolateral fusion of the lumbar spine , as the composite undergoes resorption without the formation of bridging callus . Level of Evidence Level 1 OBJECT The purpose of this study was to evaluate the effectiveness of coralline hydroxyapatite ( CHA ) and laminectomy-derived bone as an adjuvant graft material when combined with autogenous iliac bone graft ( AIBG ) in posterolateral fusion ( PLF ) . METHODS This prospect i ve , case-control study involved 58 patients who underwent lumbar instrumentation-augmented PLF for degenerative spinal stenosis-induced segmental instability between July 2000 and June 2001 . The patients were divided into three groups . Laminectomy bone and AIBG were placed in the right intertransverse process space in Group 1 ( 20 patients ) , CHA and AIBG were placed in Group 2 ( 19 patients ) , and laminectomy bone and CHA were placed in Group 3 ( 19 patients ) . Pure autogenous iliac cancellous bone graft was placed in the left intertransverse process space in all three groups of patients . Successful fusion was determined by two spine surgeons after examining the plain , anteroposterior , bilateral oblique , and lateral flexion-extension radiographs . If the examiners did not agree on fusion status , fine-cut computerized tomography scans of the fusion mass were used to make the final decision . The chi-square test was used to compare the fusion rate at different time intervals among the three groups . CONCLUSIONS Pure AIBG placed in left intertransverse process space was associated with the best fusion rate . After 6 months , CHA produced a comparable result to laminectomy-derived bone when combined with AIBG . When laminectomy bone was mixed with CHA , the combination failed to yield a satisfactory fusion rate ( 57.9 % ) even 1 year after surgery if no AIBG was added Study Design . A prospect i ve , comparative study . Objective . We developed a hybrid graft ( HBG ) of porous & bgr;-tricalcium phosphate ceramics/percutaneously harvested bone sticks/autologous bone marrow aspirate for lumbar posterolateral fusion ( PLF ) . The aim of this study was to investigate the efficacy of the HBG as a substitute for conventional corticocancellous iliac autografts . Summary of Background Data . Iliac crest bone graft ( ICBG ) has been traditionally used as the golden st and ard for lumbar spinal fusion . The significant complication rate associated with harvesting corticocancellous ICBG , however , has encouraged development of alternative graft substitutes . Methods . From September 2005 , 61 consecutive patients underwent decompressive laminotomy and 1-level instrumented PLF .  Each patient in this study had the constructs of the HBG placed on 1 side of the intertransverse process gutter . An autologous local bone graft ( LBG ) harvested during decompressive laminotomy was placed on the other side as a control . Radiographic evaluation was performed at 6 months , 1 year after surgery , and subsequently on an annual basis . The fusion statuses on either side of vertebra were compared . Results . The flexion-extension motion in the dynamic x-rays at the target level decreased over time . Only 1 case exhibited over 5 ° of angular motion 2 years after surgery . In the evaluation of fusion status , the fusion rate for the HBG side ( 68.9 % at 6 months , 83.6 % at 1 year , 93.5 % at 2 years ) was higher than that for the LBG side ( 49.2 % at 6 months , 75.4 % at 1 year , 89.1 % at 2 years ) with a significant difference at 6 months after surgery . No significant complications at the donor site were found postoperatively . Conclusion . The HBG promoted posterolateral spinal fusion without significant donor site morbidity . Because of its efficacy and safety , this hybrid construct seems promising as an alternative to conventional iliac bone grafts for lumbar spinal fusion Study Design . A prospect i ve clinical study . Objective . To evaluate whether the fusion rate of autogenous laminectomy bone chips and calcium sulfate pellets could be augmented by bone marrow aspirate ( BMA ) in one-level lumbar posterolateral fusion . Summary of Background Data . An in vivo animal study has indicated that BMA augments spinal arthrodesis . Methods . Forty-three patients undergoing surgery for instrumented one-level fusion with decompression were divided into 2 groups . Autologous iliac crest bone graft ( ICBG ) was placed in 1 posterolateral gutter ( control ) , while on the other side ( test ) , an equal quantity of laminectomy bone chips mixed with BMA while harvesting the iliac bone graft ( group 1 ) or an equal quantity of calcium sulfate pellets soaked in BMA ( group 2 ) was placed . Radiographic assessment was performed every 3 months ( 3–12 months ) and then annually . The statuses of fusion on either side of the vertebra were compared . Results . For the 21 patients in group 1 , 18 ( 85.7 % ) exhibited bone fusion on the test side , and 19 ( 90.5 % ) presented evidence of fusion on the control side . Thus , the test side with laminectomy bone chips and BMA achieved a fusion rate similar to that on the control side ( P > 0.05 ) . For the 22 patients in group 2 , 20 ( 90.9 % ) exhibited bone fusion on the control side whereas only 10 ( 45.5 % ) demonstrated complete fusion on the test side ( P < 0.05 ) , where calcium sulfate and BMA was applied . Conclusion . ICBG performs as expected with high fusion rates and laminectomy bone with BMA performs equally as well . Osteoset is significantly inferior to ICBG despite the addition of BMA , which is osteoinductive and has improved fusion rates and osteogenesis in other models
The purpose of this review was to compare the efficacy and safety of synthetic bone graft substitutes versus autograft or allograft for the treatment of lumbar and cervical spinal degenerative diseases .