A prospective randomized comparison of PEEK cage containing calcium sulphate or demineralized bone matrix with autograft in anterior cervical interbody fusion

Xie, Yubing; Li, Hua; Yuan, Junjie; Fu, Lingjie; Yang, Jianwei; Zhang, Pu

doi:10.1007/s00264-014-2610-9

Cited by 25 publications

(32 citation statements)

References 39 publications

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“…In this study, the bone union rate at 1 year and 2.3 years (range, 2.0-6.0) after surgery was 29% (8/28 segments) and 61% (11/18 segments), respectively. The bone union rate of the present result is relatively lower than that of other studies of ACDF with a PEEKc [8][9][10][11] , but this may have attributed to our strict criteria for bone fusion. In general, it is reported that PEEK has no bone conductivity itself in vitro 6) .…”

Section: Discussioncontrasting

confidence: 83%

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ACDF with a PEEK cage clinically provides a good outcome with minor donor site morbidity despite unsatisfactory radiological findings-A prospective cohort study of a PEEK cage in stand-alone usage-

Okuyama

Miyakoshi

Sasaki

et al. 2017

Spine Surg Relat Res

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Study Design A prospective cohort study was conducted on patients with anterior cervical decompression and fusion (ACDF) with a polyetheretherketone cage (PEEKc). Background Advantages of a PEEKc have been proposed in the study. However, benefits of using a PEEKc in ACDF are still controversial. Objective To investigate the advantages of a PEEKc in ACDF. Materials and Methods A total of 27 patients was enrolled in the study. The mean age of patients was 55±10 years (mean±standard deviation). The mean duration of symptoms was 17±21 months. Surgery was conducted at C3/4 in 1, C4/5 in 3, C5/6 in 11, C6/7 in 9, C7/T1 in 2, and C5/6/7 in 1 patient. The mean follow-up period was 2.1±1.3 years. Clinical outcomes were analyzed by the Japanese Orthopedic Association Scores (JOA scores) and its recovery rate. Perioperative complications were also investigated. Radiologically, studies were conducted on interbody lordotic angle (IBLA), interbody height (IBH), and bone fusion rates. Results The JOA score was 14.7±1.4 preoperatively and 16.3±1.3 at the final follow-up. A significant improvement was observed (p<0.05). The mean recovery rate of JOA scores was 74.0±25.0%. The preoperative IBLA was 0.5±6.1°. The mean IBLA at the final follow-up was 1.9±5.6°. The preoperative IBH was 34.2±3.5 mm. The mean IBH at the final follow-up was 34.3±3.5 mm. No significant improvement in IBLA and IBH was observed. A complete union rate at 1 year and 2.3 years (range, 2.0-6.0) after surgery was 29% (8/28 segments) and 61% (11/18 segments). No major complications were observed. Conclusions Despite an unsatisfactory bone union rate and no significant improvement in IBLA and IBH at the final follow-up, ACDF with a PEEKc clinically provided a stable outcome with less surgical invasion and minor donor-site morbidity.

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Section: Discussioncontrasting

confidence: 83%

“…Despite these biomechanical and surgical advantages of a PEEKc in ACDF, its clinical and radiological benefits are still controversial [7][8][9][10][11] . Therefore, it is necessary to assess whether a PEEKc provides a better clinical and radiological result in ACDF.…”

Section: Introductionmentioning

confidence: 99%

ACDF with a PEEK cage clinically provides a good outcome with minor donor site morbidity despite unsatisfactory radiological findings-A prospective cohort study of a PEEK cage in stand-alone usage-

Okuyama

Miyakoshi

Sasaki

et al. 2017

Spine Surg Relat Res

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“…The Topuz et al study [14] demonstrated a 69.6% fusion rate using DBM, which is twenty percentage points lower than the 89.4% fusion rate for TE. Another study used DBM in conjunction with a synthetic graft material [15], which is a potential confounding factor for accurate data comparison. The use INFUSE® was described in ACDF procedures [16–18].…”

Section: Discussionmentioning

confidence: 99%

“…FDA issued a public health notification of life-threatening cervical swelling (https://wayback.archive-it.org/7993/20170111190511/ http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062000.htm) when INFUSE is used in the cervical spine. Table 3 also shows high fusion rate when autograft is used [15]. However, harvesting of autograft requires a second operative site which is associated with pain and morbidity that includes chronic harvest site pain, infection, increased operative time, and blood loss [19–23].…”

Section: Discussionmentioning

confidence: 99%

Prospective clinical and radiographic evaluation of an allogeneic bone matrix containing stem cells (Trinity Evolution® Viable Cellular Bone Matrix) in patients undergoing two-level anterior cervical discectomy and fusion

et al. 2017

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BackgroundTrinity Evolution® (TE), a viable cellular bone allograft, previously demonstrated high fusion rates and no safety-related concerns after single-level anterior cervical discectomy and fusion (ACDF) procedures. This prospective multicenter clinical study was performed to assess the radiographic and clinical outcomes of TE in subjects undergoing two-level ACDF procedures.MethodsIn a prospective, multicenter study, 40 subjects that presented with symptomatic cervical degeneration at two adjacent vertebral levels underwent instrumented ACDF using TE autograft substitute in a polyetherethereketone (PEEK) cage. At 12 months, radiographic fusion status was evaluated by dynamic motion plain radiographs and thin cut CT with multiplanar reconstruction by a panel that was blinded to clinical outcome. Fusion success was defined by angular motion (≤4°) and the presence of bridging bone across the adjacent vertebral endplates. Clinical pain and function assessments included the Neck Disability Index (NDI), neck and arm pain as evaluated by visual analog scales (VAS), and SF-36 at both 6 and 12 months.ResultsAt both 6 and 12 months, all clinical outcome scores (SF-36, NDI, and VAS pain) improved significantly (p < 0.05) compared to baseline values. There were no adverse events or infections that were attributed to the graft material, no subjects that required revisions, and no significant decreases to mean neurological evaluations at any time as compared to baseline. At 12 months, the per subject and per level fusion rate was 89.4 and 93.4%, respectively. Subgroup analysis of subjects with risk factors for pseudoarthrosis (current or former smokers, diabetic, or obese/extremely obese) compared to those without risk factors demonstrated no significant differences in fusion rates.ConclusionsPatients undergoing two-level ACDF with TE in combination with a PEEK interbody spacer and supplemental anterior fixation had a high rate of fusion success without any serious adverse events related to the graft material.Trial registrationTrinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF) NCT00951938

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“…They found fusion was achieved in 93.5% of patients after a median follow-up of 23 months. In the other 12 articles, the analysis was performed by a clinician, usually a neuro-or orthopaedic surgeon [12,29,35,61,67,69,87,92,96,[109][110][111]. They found fusion was achieved in 85.5% of patients after a median follow-up of 23 months.…”

Section: Methods Of Measuring Bony Fusionmentioning

confidence: 99%

Evaluation of bony fusion after anterior cervical discectomy: a systematic literature review

2018

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Purpose Anterior cervical discectomy and fusion (ACDF) has proven effective in treating radicular arm pain. Post-operatively, cervical spine stability is temporarily challenged, but data on bony fusion and speed of fusion are ambiguous; optimum evaluation method and criteria are debated. Aim To study bony fusion accomplishment and to obtain an overview of methods to evaluate fusion. Methods A literature search was performed in PubMed and Embase. Included studies had to report original data concerning 1-or 2-level ACDF with intervertebral device or bone graft, where bony fusion was assessed using CT scans or X-rays. Results A total of 146 articles comprising 10,208 patients were included. Bony fusion was generally defined as "the presence of trabecular bridging" and/or "the absence of motion". Fusion was accomplished in 90.1% of patients at the final follow-up. No gold standard for assessment could be derived from the results. Addition of plates and/or cages with screws resulted in slightly higher accomplishment of fusion, but differences were not clinically relevant. Eighteen studies correlated clinical outcome with bony fusion, and 3 found a significant correlation between accomplishment and better clinical outcome. Conclusions In approximately 90% of patients, bony fusion is accomplished one year after ACDF. As there is no generally accepted definition of bony fusion, different measuring techniques cannot be compared to a gold standard and it is impossible to determine the most accurate method. Variations in study design hamper conclusions on optimising the rate of bony fusion by choice of material and/or additives. Insufficient attention is paid to correlation between bony fusion and clinical outcome.Graphical abstract These slides can be retrieved from electronic supplementary material.

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A prospective randomized comparison of PEEK cage containing calcium sulphate or demineralized bone matrix with autograft in anterior cervical interbody fusion

Cited by 25 publications

References 39 publications

ACDF with a PEEK cage clinically provides a good outcome with minor donor site morbidity despite unsatisfactory radiological findings-A prospective cohort study of a PEEK cage in stand-alone usage-

ACDF with a PEEK cage clinically provides a good outcome with minor donor site morbidity despite unsatisfactory radiological findings-A prospective cohort study of a PEEK cage in stand-alone usage-

Prospective clinical and radiographic evaluation of an allogeneic bone matrix containing stem cells (Trinity Evolution® Viable Cellular Bone Matrix) in patients undergoing two-level anterior cervical discectomy and fusion

Evaluation of bony fusion after anterior cervical discectomy: a systematic literature review

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