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Structural Allograft Versus PEEK Implants in Anterior Cervical Discectomy and Fusion: A Systematic Review.

ABSTRACT: STUDY DESIGN:Systematic literature review. OBJECTIVE:Our primary objective was to compare reported fusion rates after anterior cervical discectomy and fusion (ACDF) using structural allograft versus polyetheretherketone (PEEK) interbody devices in patients with cervical spine degeneration. Our secondary objectives were to compare differences in rates of subsidence and reoperation and in patient-reported outcomes between the 2 groups. METHODS:Through a systematic review of the English-language literature using various databases, we identified 4702 articles. After we applied inclusion and exclusion criteria, 14 articles (7 randomized controlled trials, 4 prospective studies, and 3 retrospective studies) reporting fusion rates of structural allograft or PEEK interbody devices were eligible for our analysis. No randomized controlled trials compared outcomes of structural allograft versus PEEK interbody devices. Extracted data included authors, study years, study designs, sample sizes, patient ages, duration of follow-up, types of interbody devices used, fusion rates, definition of fusion, reoperation rates, subsidence rates, and patient-reported outcomes. RESULTS:Fusion rates were 82% to 100% for allograft and 88% to 98% for PEEK interbody devices. The reported data were insufficient to perform meta-analysis. Structural allograft had the highest reported rate of reoperation (14%), and PEEK interbody devices had the highest reported subsidence rate (18%). Patient-reported outcomes improved in both groups. There was insufficient high-quality evidence to compare the associations of various PEEK modifications with fusion rates. CONCLUSION:Fusion rates were similar between structural allograft and PEEK interbody devices when used for ACDF for cervical spine degeneration. Currently, there is insufficient high-quality evidence to assess associations of PEEK modifications with fusion rates. LEVEL OF EVIDENCE:II.

SUBMITTER: Jain A

PROVIDER: S-EPMC7383799 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Structural Allograft Versus PEEK Implants in Anterior Cervical Discectomy and Fusion: A Systematic Review.

Jain Amit A Marrache Majd M Harris Andrew A Puvanesarajah Varun V Neuman Brian J BJ Buser Zorica Z Wang Jeffrey C JC Yoon S Tim ST Meisel Hans Jörg HJ

Global spine journal 20191025 6

<h4>Study design</h4>Systematic literature review.<h4>Objective</h4>Our primary objective was to compare reported fusion rates after anterior cervical discectomy and fusion (ACDF) using structural allograft versus polyetheretherketone (PEEK) interbody devices in patients with cervical spine degeneration. Our secondary objectives were to compare differences in rates of subsidence and reoperation and in patient-reported outcomes between the 2 groups.<h4>Methods</h4>Through a systematic review of t ...[more]

PMID: 32707023

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Project description:BackgroundAnterior cervical discectomy and fusion is a standard surgical treatment for cervical radiculopathy and myelopathy, but reoperations sometimes are performed to treat complications of fusion such as pseudarthrosis and adjacent-segment degeneration. A cervical disc arthroplasty is designed to preserve motion and avoid the shortcomings of fusion. Available evidence suggests that a cervical disc arthroplasty can provide pain relief and functional improvements similar or superior to an anterior cervical discectomy and fusion. However, there is controversy regarding whether a cervical disc arthroplasty can reduce the frequency of reoperations.Questions/purposesWe performed a meta-analysis of randomized controlled trials (RCTs) to compare cervical disc arthroplasty with anterior cervical discectomy and fusion regarding (1) the overall frequency of reoperation at the index and adjacent levels; (2) the frequency of reoperation at the index level; and (3) the frequency of reoperation at the adjacent levels.MethodsPubMed, EMBASE, and the Cochrane Register of Controlled Trials databases were searched to identify RCTs comparing cervical disc arthroplasty with anterior cervical discectomy and fusion and reporting the frequency of reoperation. We also manually searched the reference lists of articles and reviews for possible relevant studies. Twelve RCTs with a total of 3234 randomized patients were included. Eight types of disc prostheses were used in the included studies. In the anterior cervical discectomy and fusion group, autograft was used in one study and allograft in 11 studies. Nine of 12 studies were industry sponsored. Pooled risk ratio (RR) and associated 95% CI were calculated for the frequency of reoperation using random-effects or fixed-effects models depending on the heterogeneity of the included studies. A funnel plot suggested the possible presence of publication bias in the available pool of studies; that is, the shape of the plot suggests that smaller negative or no-difference studies may have been performed but have not been published, and so were not identified and included in this meta-analysis.ResultsThe overall frequency of reoperation at the index and adjacent levels was lower in the cervical disc arthroplasty group (6%; 108/1762) than in the anterior cervical discectomy and fusion group (12%; 171/1472) (RR, 0.54; 95% CI, 0.36-0.80; p = 0.002). Subgroup analyses were performed according to secondary surgical level. Compared with anterior cervical discectomy and fusion, cervical disc arthroplasty was associated with fewer reoperations at the index level (RR, 0.50; 95% CI, 0.37-0.68; p < 0.001) and adjacent levels (RR, 0.52; 95% CI, 0.37-0.74; p < 0.001).ConclusionsCervical disc arthroplasty is associated with fewer reoperations than anterior cervical discectomy and fusion, indicating that it is a safe and effective alternative to fusion for cervical radiculopathy and myelopathy. However, because of some limitations, these findings should be interpreted with caution. Additional studies are needed.Level of evidenceLevel I, therapeutic study.

Project description:BackgroundCervical disc arthroplasty (CDA) has emerged as an alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of cervical pathologies. Studies are on-going to assess the long term outcomes of CDA. This study assessed the safety and efficacy of the Prestige(®) LP Disc at 84-months follow up.MethodsProspective data from 280 CDA patients with single-level cervical disc disease with radiculopathy or myelopathy were compared with 265 historical control ACDF patients. Clinical and radiographic follow up was completed pre-operatively, intraoperatively, and at intervals up to 84 months.ResultsFollow-up rate was 75.9% for CDA and 70.0% for ACDF patients. Statistical improvements (p < 0.001) in Neck Disability Index (NDI), neck/arm pain, and SF-36 were achieved by 1.5 months in both groups and maintained through 84 months. At 84 months, 86.1% of CDA versus 80.1% of ACDF patients achieved NDI success, (≥15-point improvement over baseline). Mean NDI score improvements exceeded 30 points in both groups. SF-36 PCS/MCS mean improvements were 13.1±11.9/8.2±12.3 points for CDA and 10.7±11.8/8.3±13.6 points for ACDF. Neurological success was 92.8% for CDA and 79.7% for ACDF patients. The rate of Overall Success was 74.9% for CDA and 63.2% for ACDF. At 84 months, 17.5% of CDA and 16.6% of ACDF patients had a possibly implant- or implant-surgical procedure-related adverse event. Eighteen (6.4%) CDA and 29 (10.9%) ACDF patients had a second surgery at the index level. In CDA patients, mean angular motion at the target level was maintained at 24 (7.5°) and 84 (6.9°) months. Bridging bone was reported in 5.9%/9.5%/10.2%/13.0% of CDA patients at 24/36/60/84 months. Change in mean preoperative angulation of the adjacent segment above/below the index level was1.06±4.39/1.25±4.06 for CDA and (-0.23)±5.37/1.25±5.07 for ACDF patients. At 84 months, 90.9% of CDA and 85.6% of ACDF patients were satisfied with the results of their treatment.ConclusionsPrestige LP maintained significantly improved clinical outcomes and segmental motion; statistical superiority of CDA was concluded for overall success. This investigational device exemption study was sponsored by Medtronic Spinal and Biologics, Memphis, TN. Study approved by the Hughston Sports Medicine Center Institutional Review Board on January 7, 2005. Clinical trial registered at clinicaltrials.gov: NCT00667459. All participants signed an informed consent.

Project description:BackgroundAdult spinal deformity, especially sagittal imbalance, is affecting health-related quality-of-life (HRQOL) scores. There is a lack of emphasis in the comparison of cervical sagittal parameters in patients with degenerative cervical spondylolisthesis and degenerative cervical kyphosis. The aim of study is to determine the preoperative and postoperative cervical sagittal parameters in myeloradiculopathic patients with degenerative cervical spondylolisthesis and degenerative cervical kyphosis treated by anterior cervical discectomy and fusion (ACDF).MethodsA retrospective medical records and radiographic study of 30 adult patients were reviewed. Fifteen patients with degenerative cervical spondylolisthesis and 15 patients with degenerative cervical kyphosis have been performed ACDF from 2010-2020. We measured the preoperative and postoperative cervical sagittal parameters: C0-C2 angle, C1-C2 angle, C2-C7 angle, C2-C7 sagittal vertical axis (SVA), T1 slope, neck tilt angle and thoracic inlet angle. Minimum follow-up period was at least 2 years.ResultsPatients in degenerative cervical kyphosis group have C2-C7 angle less than degenerative cervical spondylolisthesis group (-14.88±7.32 vs. 9.60±13.60), leading to increase the mismatch between T1 slope and C2-C7 angle in kyphotic group and hyperlordosis of C0-C2 angle and C1-C2 angle (31.13±7.68, 37.88±5.08) compare with spondylolisthesis group (13±10.20, 24.60±10.70). Whereas patients with degenerative cervical spondylolisthesis have C2-C7 SVA (33.22±13.92) more than kyphosis group (13.70±13.60). After surgery, there is significant increase of the C2-C7 angle in the kyphosis group compare before and after surgery (-14.88±7.32 vs. 4.10±11.80). While the spondylolisthesis group has no significantly different parameters compare to before surgery. However, the postoperative cervical sagittal parameters of all patients are within the normal thresholds (T1-Slope minus C2-C7 lordosis <15° and C2-C7 SVA <40 mm).ConclusionsThe study demonstrates the difference of sagittal parameters between degenerative cervical spondylolisthesis and kyphosis before and after surgery. ACDF not only provides neural decompressive procedure, but also corrects the regional cervical sagittal parameters.

Project description:Study designSystematic review.ObjectiveTo compare the effectiveness and safety between iliac crest bone graft (ICBG), non-ICBG autologous bone, and allograft in cervical spine fusion. To avoid problems at the donor site, various allograft materials have been used as a substitute for autograft. However, there are still questions as to the comparative effectiveness and safety of cadaver allograft compared with autologous ICBG.MethodsA systematic search of multiple major medical reference databases was conducted to identify studies evaluating spinal fusion in patients with cervical degenerative disk disease using ICBG compared with non-ICBG autograft or allograft or non-ICBG autograft compared with allograft in the cervical spine. Radiographic fusion, patient-reported outcomes, and functional outcomes were the primary outcomes of interest. Adverse events were evaluated for safety.ResultsThe search identified 13 comparative studies that met our inclusion criteria: 2 prospective cohort studies and 11 retrospective cohort studies. Twelve cohort studies compared allograft with ICBG autograft during anterior cervical fusion and demonstrated with a low evidence level of support that there are no differences in fusion percentages, pain scores, or functional results. There was insufficient evidence comparing patients receiving allograft with non-ICBG autograft for fusion, pain, revision, and functional and safety outcomes. No publications directly comparing non-ICBG autograft with ICBG were found.ConclusionAlthough the available literature suggests ICBG and allograft may have similar effectiveness in terms of fusion rates, pain scores, and functional outcomes following anterior cervical fusion, there are too many limitations in the available literature to draw any significant conclusions. No individual study provided greater than class III evidence, and when evaluating the overall body of literature, no conclusion had better than low evidence support. A prospective randomized trial with adequate sample size to compare fusion rates, efficacy measures, costs, and safety is warranted.

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Structural Allograft Versus PEEK Implants in Anterior Cervical Discectomy and Fusion: A Systematic Review.

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Structural Allograft Versus PEEK Implants in Anterior Cervical Discectomy and Fusion: A Systematic Review.

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