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Feasibility of CaO-SiO2-P2O5-B2O3 Bioactive Glass Ceramic Cage in Anterior Cervical Diskectomy and Fusion.
Park, S, Lee, DH, Seo, J, Kim, KJ, Lee, SK, Park, JH, Cho, JH, Park, JW, Hwang, CJ, Yang, JJ, et al
World neurosurgery. 2020;:e358-e366
Abstract
BACKGROUND CaO-SiO2-P2O5-B2O3 bioactive glass ceramic (BGC) is known to chemically bond with bones by forming a hydroxyapatite layer and inducing osteoblastic differentiation. This study was conducted to compare the clinical outcomes, radiographic outcomes, and safety of a CaO-SiO2-P2O5-B2O3 BGC cage in anterior cervical diskectomy and fusion (ACDF) with those of an allograft interbody spacer. METHODS A total of 63 patients who underwent 2-level ACDF to treat degenerative cervical radiculopathy/myelopathy were reviewed. Results from 26 patients who were recruited prospectively using CaO-SiO2-P2O5-B2O3 BGC as a cage material (BGC group) were compared with a historical control group of 37 patients who underwent surgery using an allograft (allograft group). Fusion rates, subsidence, and adjacent segment degeneration were compared between the groups. Demographic data, fusion rates, visual analog scale (VAS) scores for neck or arm pain, Neck Disability Index (NDI) scores, and complications were also compared. RESULTS Fusion rates were 88.5% when assessed by interspinous motion and 92.3% when assessed by intragraft bone bridging in the BGC group at 12-month follow-up. The neck pain or arm pain VAS scores and NDI scores significantly improved in both groups. No material-related complications were observed in the BGC group, such as graft resorption and breakage. Fusion rates, subsidence, neck pain or arm pain VAS scores, and NDI scores did not significantly differ between the BGC and allograft groups. CONCLUSIONS CaO-SiO2-P2O5-B2O3 BGC cage was effective and safe when used in ACDF, conferring a high fusion rate and favorable clinical outcomes similar to those of the allograft.
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Clinical and radiological results comparison of allograft and polyetheretherketone cage for one to two-level anterior cervical discectomy and fusion: A CONSORT-compliant article.
Yang, S, Yu, Y, Liu, X, Zhang, Z, Hou, T, Xu, J, Wu, W, Luo, F
Medicine. 2019;(45):e17935
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Abstract
BACKGROUND Recently, many kinds of cages for cervical fusion have been developed to avoid the related complications caused by tricortical iliac crest graft. The existing literature has reported the excellent clinical efficacy and superior fusion rate. However, various types of cages have their own disadvantages. Which bone graft material is the best choice for cage with the fewest complications? At present, there is still no conclusion. METHODS By reviewing patients with 1 to 2-level cervical degenerative disease in our hospital with a novel cage made of allograft or polyetheretherketone (PEEK), we evaluated the efficacy and reliability of the new cage in anterior cervical discectomy and fusion (ACDF). From 2015 to 2016, a prospective review of 58 and 49 consecutive cases with spondylotic radiculopathy or myelopathy undergoing ACDF using allograft (group A) and PEEK (group B) cage were performed. The follow-up ranged from 12 to 40 months. Intraoperative index, clinical outcome and complications were recorded. Radiographs evaluated segmental and overall cervical lordosis, the height of the intervertebral space, interbody height ratio (IHR), cage positioning, and fusion state. RESULTS A total of 134 cages were implanted. Compared to preoperatively, the visual analog scale (VAS) and neck disability index (NDI) were reduced postoperatively without any change during the subsequent follow-up in both groups. There was no migration or extrusion of the cages at the latest follow-up. There were 2 and 4 patients suffering dysphagia respectively. In both groups, the intervertebral height, IHR, segmental and overall cervical lordosis were significantly greater than pre-operation (P < .05) and were maintained at the last follow-up, but were not statistically significant (P > .05). The allograft group achieved a fusion rate of 100% (58/58) according to CT scans at 3 months post-operation, while PEEK group was 91.8% (45/49), which reached 95.9% (47/49) at 6 months and 100% at 12 months. In addition, the fusion state was maintained in all patients at the last follow-up. CONCLUSION Our data showed that the new allograft cage is superior to the PEEK cage in providing a high fusion rate and fewer complications after 1-level and 2-level ACDF procedures. It may represent an excellent alternative to other cages.
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Application of New Allogeneic Lumbar Fusion Cage (Biocage) in Single-Segment Lumbar Degenerative Disease: A Prospective Controlled Study with Follow-Up for ≥2 Years.
Wu, WJ, Li, Y, Hou, TY, Cheng, P, Zhang, ZH, Xu, JZ, Luo, F
World neurosurgery. 2019;:e1309-e1314
Abstract
OBJECTIVE We evaluated the clinical efficacy of the Biocage in lumbar fusion surgery and its safety and effectiveness. METHODS A total of 431 patients with single-segment lumbar degenerative disease diagnosed from January 2013 to December 2016 were considered for the present prospective, nonrandomized, and controlled study; 52 patient met the exclusion criteria and were excluded. The patients were divided into 2 groups according to their cage choice: Biocage (n = 206) and polyether ether ketone (PEEK) cage (n = 173). The patients were followed up for 24-48 months (average, 32). The operative time, blood loss, hospitalization duration, mean intervertebral fusion segment height, height of intervertebral foramen, fusion time, fusion rate, internal fixation failure rate, visual analog scale score, and Oswestry disability index were compared between the 2 groups. RESULTS All the patients underwent surgery successfully. No significant differences were found in gender, age, clinical diagnosis, lesion segment, operative time, blood loss, visual analog scale score, or Oswestry disability index between the 2 groups. No significant differences were found in the fusion rate; however, the Biocage group had a greater fusion rate and shorter fusion time than the PEEK group. During follow-up, the mean intervertebral height recovered significantly in the Biocage group compared with the PPEK group (P < 0.05). The height of the intervertebral foramen was significantly different between the 2 groups, and recovery was better in the Biocage group (P < 0.05). The Cobb angle of fusion segment in both groups improved significantly postoperatively compared with preoperatively (P < 0.05). The improvement in Cobb angle was significantly different between the 2 groups (P < 0.05). CONCLUSIONS The Biocage has excellent clinical efficacy in the treatment of lumbar degenerative disease. Although the Biocage achieved good therapeutic effects, it did not show obvious advantages compared with the PEEK cage. Therefore, the Biocage can only be used as a choice of bone graft materials for lumbar fusion surgery and should not completely replace the PEEK cage.
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The use of beta-tricalcium phosphate and bone marrow aspirate as a bone graft substitute in posterior lumbar interbody fusion.
Thaler, M, Lechner, R, Gstöttner, M, Kobel, C, Bach, C
European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2013;(5):1173-82
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PURPOSE Due to the disadvantages of iliac crest bone and the poor bone quality of autograft gained from decompression surgery, alternative filling materials for posterior lumbar interbody fusion cages have been developed. β-Tricalcium phosphate is widely used in cages. However, data regarding the fusion rate of β-TCP assessed by computer tomography are currently not available. MATERIALS A prospective clinical trial involving 34 patients (56.7 years) was performed: 26 patients were treated with single-level, five patients double-level and three patients triple-level PLIF filled with β-TCP and bone marrow aspirate perfusion, and additional posterior pedicle screw fixation. Fusion was assessed by CT and X-rays 1 year after surgery using a validated fusion scale published previously. Functional status was evaluated with the visual analogue scale and the Oswestry Disability Index before and 1 year after surgery. RESULTS Forty-five levels in 34 patients were evaluated by CT and X-ray with a follow-up period of at least 1 year. Clinically, the average ODI and VAS for leg and back scores improved significantly (P < 0.001). CT assessment revealed solid fusion in 12 levels (26.67%) and indeterminate fusion in 15 levels (34.09%). Inadequate fusion (non-union) was detected in 17 levels (38.63%). CONCLUSION The technique of PLIF using β-TCP yielded a good clinical outcome 1 year after surgery, however, a high rate of pseudoarthrosis was found in this series therefore, we do not recommend β-TCP as a bone graft substitute using the PLIF technique.
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Hybrid grafting using bone marrow aspirate combined with porous β-tricalcium phosphate and trephine bone for lumbar posterolateral spinal fusion: a prospective, comparative study versus local bone grafting.
Yamada, T, Yoshii, T, Sotome, S, Yuasa, M, Kato, T, Arai, Y, Kawabata, S, Tomizawa, S, Sakaki, K, Hirai, T, et al
Spine. 2012;(3):E174-9
Abstract
STUDY DESIGN A prospective, comparative study. OBJECTIVE We developed a hybrid graft (HBG) of porous β-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 standard 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.
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The first clinical trial of beta-calcium pyrophosphate as a novel bone graft extender in instrumented posterolateral lumbar fusion.
Lee, JH, Chang, BS, Jeung, UO, Park, KW, Kim, MS, Lee, CK
Clinics in orthopedic surgery. 2011;(3):238-44
Abstract
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 prospective, 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 randomly 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.
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Anterior cervical discectomy with fusion in patients with cervical disc degeneration: a prospective outcome study of 258 patients (181 fused with autologous bone graft and 77 fused with a PEEK cage).
Lied, B, Roenning, PA, Sundseth, J, Helseth, E
BMC surgery. 2010;:10
Abstract
BACKGROUND Anterior cervical discectomy with fusion (ACDF) is challenging with respect to both patient selection and choice of surgical procedure. The aim of this study was to evaluate the clinical outcome of ACDF, with respect to both patient selection and choice of surgical procedure: fusion with an autologous iliac crest graft (AICG) versus fusion with an artificial cage made of polyetheretherketone (PEEK). METHODS This was a non-randomized prospective single-center outcome study of 258 patients who underwent ACDF for cervical disc degeneration (CDD). Fusion was attained with either tricortical AICG or PEEK cages without additional anterior plating, with treatment selected at surgeon's discretion. Radicular pain, neck-pain, headache and patient satisfaction with the treatment were scored using the visual analogue scale (VAS). RESULTS The median age was 47.5 (28.3-82.8) years, and 44% of patients were female. 59% had single-level ACDF, 40% had two level ACDF and 1% had three-level ACDF. Of the patients, 181 were fused with AICG and 77 with a PEEK-cage. After surgery, the patients showed a significant reduction in radicular pain (DeltaVAS = 3.05), neck pain (DeltaVAS = 2.30) and headache (DeltaVAS = 0.55). Six months after surgery, 48% of patients had returned to work: however 24% were still receiving workers' compensation.Using univariate and multivariate analyses we found that high preoperative pain intensity was significantly associated with a decrease in pain intensity after surgery, for all three pain categories. There were no significant correlations between pain relief and the following patient characteristics: fusion method (AICG or PEEK-cage), sex, age, number of levels fused, disc level fused, previous neck surgery (except for neck pain), previous neck trauma, or preoperative symptom duration. Two hundred out of the 256 (78%) patients evaluated the surgical result as successful. Only 27/256 (11%) classified the surgical result as a failure. Patient satisfaction was significantly associated with pain relief after surgery. CONCLUSIONS ACDF is an effective treatment for radicular pain in selected patients with CDD after six months follow up. Because of similar clinical outcomes and lack of donor site morbidity when using PEEK, we now prefer fusion with PEEK cage to AICG. Lengthy symptom duration was not a negative prognostic marker in our patient population. The number of patients who returned to work 6 months after surgery was lower than expected.
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A level-1 pilot study to evaluate of ultraporous beta-tricalcium phosphate as a graft extender in the posterior correction of adolescent idiopathic scoliosis.
Lerner, T, Bullmann, V, Schulte, TL, Schneider, M, Liljenqvist, U
European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2009;(2):170-9
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The objective of this study is to compare the clinical and radiographic results of ultraporous beta-tricalcium phosphate (beta-TCP) versus autogenous iliac crest bone graft (ICBG), through prospective randomized pilot study (EBM-Level 1), as graft extenders in scoliosis surgery. In the posterior correction of scoliosis, local bone resected as part of the procedure is used as the base bone graft material. Supplemental grafting from the iliac crest is considered the gold-standard in posterior spinal fusion. However, autograft is not available in unlimited quantities, and bone harvesting is a source of significant morbidity. Ultraporous beta-TCP might be a substitute for ICBG in these patients and thus eliminate donor site morbidity. A total of 40 patients with adolescent idiopathic scoliosis (AIS) were randomized into two treatment groups and underwent corrective posterior instrumentation. In 20 patients, ICBG harvesting was performed whereas the other half received beta-TCP (VITOSS) to augment the local bone graft. If thoracoplasty was performed, the resected rib bone was added in both groups. Patients were observed clinically and radiographically for a minimum of 20 months postoperatively, with a mean follow-up of 4 years. Overall pain and pain specific to the back and donor site were assessed using a visual analog scale (VAS). As a result, both groups were comparable with respect to the age at the time of surgery, gender ratio, preoperative deformity, and hence length of instrumentation. There was no significant difference in blood loss and operative time. In nine patients of the beta-TCP group and eight patients of the ICBG group, thoracoplasty was performed resulting in a rib graft of on average 7.9 g in both groups. Average curve correction was 61.7% in the beta-TCP group and 61.2% in the ICBG group at hospital discharge (P=0.313) and 57.2 and 54.3%, respectively, at follow-up (P=0.109). Loss of curve correction amounted on average 2.6 degrees in the beta-TCP group and 4.2 degrees in the comparison group (P=0.033). In the ICBG group, four patients still reported donor site pain of on average 2/10 on the VAS at last follow-up. One patient in the beta-TCP group was diagnosed with a pseudarthrosis at the caudal end of the instrumentation. Revision surgery demonstrated solid bone formation directly above the pseudarthrosis with no histological evidence of beta-TCP in the biopsy taken. In conclusion, the use of beta-TCP instead of ICBG as extenders of local bone graft yielded equivalent results in the posterior correction of AIS. The promising early results of this pilot study support that beta-TCP appears to be an effective bone substitute in scoliosis surgery avoiding harvesting of pelvic bone and the associated morbidity.
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Beta tricalcium phosphate: observation of use in 100 posterolateral lumbar instrumented fusions.
Epstein, NE
The spine journal : official journal of the North American Spine Society. 2009;(8):630-8
Abstract
BACKGROUND Beta tricalcium phosphate (B-TCP) is increasingly used to supplement lamina autograft to perform posterolateral lumbar-instrumented arthrodesis. PURPOSE To determine the radiographic arthrodesis and pseudarthrosis rates after multisegment lumbar laminectomies and one- or two-segment posterolateral instrumented fusion using lamina autograft and an artificial bone graft expander B-TCP (Vitoss; Orthovita, Malvern, PA, USA). STUDY DESIGN/SETTING To document radiographic arthrodesis/pseudarthrosis rates using lamina autograft and B-TCP. PATIENT SAMPLE One hundred patients with lumbar spinal stenosis underwent multisegment laminectomies (average 3.6 segments) and one- (78 patients) or two- (22 patients) segment posterolateral instrumented arthrodesis. OUTCOME MEASURES Two-year postoperative outcomes were assessed using Short-Form 36 questionnaires. METHODS The arthrodesis mass consisted of lamina autograft and B-TCP. Two independent neuroradiologists, using both dynamic X-rays and 2D-CT studies performed 3, 4.5, 6, and up to 12 months postoperatively, documented radiographic arthrodesis progression. RESULTS One-segment arthrodesis was performed in 79 patients; 74 (93.7%) were radiographically fused "early" (6.5 postoperative months), 2 (2.5%) fused "late" (6.5-12 months), and 3 (3.8%) exhibited pseudarthrosis. Two-segment arthrodesis was performed in 21 patients; 14 (66.7%) radiographically fused "early," 5 (23.8%) fused "late," and 2 (9.5%) exhibited pseudarthrosis. Although chi-square analyses revealed a significant increase in the number of "late" radiographic fusions occurring for patients undergoing two-level arthrodesis, no significant difference in radiographic pseudarthrosis rates was noted between the two patient populations. In both groups, Short-Form 36 questionnaires revealed nearly comparable maximal improvement on seven of eight Health Scales by the second postoperative year. CONCLUSIONS At 6.5 months after multisegment lumbar laminectomies with posterolateral instrumented lumbar arthrodesis using lamina autograft/B-TCP, more one-segment (93.7%) versus two-segment (66.7%) radiographic arthrodesis occurred. By 1 year after operation, there was no significant difference in fusion rates between one- and two-segment radiographic arthrodeses.
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Posterior lumbar interbody fusion using rhBMP-2.
Meisel, HJ, Schnöring, M, Hohaus, C, Minkus, Y, Beier, A, Ganey, T, Mansmann, U
European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2008;(12):1735-44
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The use of biological technologies for the treatment of degenerative spinal diseases has undergone rapid clinical and scientific development. BMP strategies have gained wide support for an inherent potential to improve the ossification process. It has been extensively studied in combination with various techniques for spinal stabilisation from both anterior and posterior approach. We studied the fusion process after implantation of rhBMP-2 in 17 patients with degenerative lumbar spine diseases in combination with dorsal fixation with pedicle screws and poly-ether-ether-ketone (PEEK) interbody cages. We used 12 mg rhBMP-2 carried by collagen sponge, 6 mg in every cage. Patient follow up consisted of pre-operative radiographic and clinical evaluation. Similar post-operative evaluations were performed at 3 and 6 months. Clinical assessment demonstrated clear improvement in all patients despite evidence of vertebral endplate osteoclastic activity in the 3-month radiographs. The 6-month radiograph, however, confirmed evidence of fusion, and no untoward results or outcomes were noted. While previous studies have shown exclusively positive results in both fusion rates and process, our study demonstrated an intermediate morphology at 3 months during the ossification process using Induct Os in combination with peek-cages using a PLIF-technique. The transient resorption of bone surrounding the peek cage did not result in subsidence, pain or complication, and fusion was reached in all cases within a 6-month-controlled evaluation. Although there was no negative influence on clinical outcome, the potential for osteoclastic or metabolic resorption bears watching during the post-surgical follow up.