| Literature DB >> 32707023 |
Amit Jain1, Majd Marrache1, Andrew Harris1, Varun Puvanesarajah1, Brian J Neuman1, Zorica Buser2, Jeffrey C Wang2, S Tim Yoon3, Hans Jörg Meisel4.
Abstract
STUDYEntities:
Keywords: allograft; anterior cervical discectomy and fusion; cervical spine degeneration; fusion rate; interbody device; patient-reported outcome; polyetheretherketone interbody device; structural allograft; systematic review
Year: 2019 PMID: 32707023 PMCID: PMC7383799 DOI: 10.1177/2192568219883256
Source DB: PubMed Journal: Global Spine J ISSN: 2192-5682
Figure 1.Literature search performed using PubMed, Embase, The Cochrane Library, Web of Science, Scopus, ClinicalTrials.gov, and CINAHL Plus databases in October 2018. The purpose was to compare the fusion rates of structural allograft versus polyetheretherketone interbody devices in patients who underwent anterior cervical discectomy and fusion for cervical spine degeneration.
Studies of Fusion Rates in Patients Who Underwent Anterior Cervical Discectomy and Fusion for Cervical Spine Degeneration.
| First Author, Year | Study Characteristics | Outcomes (%) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Design | Study Groups | Sample Size | Mean Age (Years) | Follow-up (Years) | Indications (No. of Patients) | Levels (No. of Patients) | 2-Year Fusion | Reoperation | Subsidence | |
| Feiz-Erfan,[ | RCT | Allograft with vs without platelets | 50 | 46 | 2 | DDD (29); herniated disc (21) | 1 (18); 2 (29) | 85 | 4 | NR |
| Campbell,[ | RCT | Allograft with vs without cervical collar | 257 | 44 | 2 | Radiculopathy or myelopathy | 1 (257) | 96 (braced); 100 (nonbraced) | 0.7 | NR |
| Feng,[ | RCT | PEEK with vs without tricalcium phosphate | 23 | 64 | 2 | Radiculopathy (12); myelopathy (5); radiculomyelopathy (6) | 1 (5); 2 (12); 3 (6) | 98 | NR | 0 |
| Coric,[ | RCT | Allograft vs arthroplasty | 133 | 44 | 2 | Radiculopathy or myelopathy | 1 (133) | 82 | 5 | NR |
| Gornet,[ | RCT | Allograft vs arthroplasty | 188 | 47 | 2 | Radiculopathy or myelopathy | 2 (188) | 82 | 8 | 4 |
| Hisey,[ | RCT | Allograft vs arthroplasty | 81 | 44 | 4 | Radiculopathy or myelopathy | 1 (81) | 94a | NR | NR |
| Mummaneni,[ | RCT | Allograft vs arthroplasty | 265 | 44 | 2 | Radiculopathy or myelopathy | 1 (265) | 98 | 8.6 | NR |
| Suchomel,[ | PC | Allograft vs autograft | NAb | 48 | 2 | Spondylosis and/or cervical disc prolapse/protrusion | 1 or 2 (NAb) | 93 | NR | 0 |
| Zigler,[ | PC | 1- vs 2-level allograft | 186 | 45 | 5 | Radiculopathy or myelopathy | 1 (81); 2 (105) | 89 (1-level); 79 (2-level) | 14 | NR |
| Schlosser,[ | RC | Allograft | 219 | 52 | 6 | Unknown | 1 (80); 2 (57); 3 (53); 4 (29) | 98c | 8 | NR |
| El-Tantawy,[ | PC | 2- vs 3- vs 4-level PEEK implant | 28 | 40 | 2 | Neck pain and radiculopathy | 2 (10); 3 (10); 4 (8) | 93 | 0 | 2 |
| Niu,[ | PC | PEEK vs titanium implant | 25 | 52 | 2 | Radiculopathy or myelopathy | 1 (16); 2 (9) | 100d | 0 | 0 |
| Cabraja,[ | RC | PEEK vs titanium implant | 42 | 58 | 2 | Radiculopathy (34); myelopathy (8) | 1 (42) | 88e | NR | 14 |
| Dufour,[ | RC | PEEK implant | 28 | 48 | 2.7 | Radiculopathy or myelopathy | 1 (19); 2 (9) | 94 | NR | 0 |
Abbreviations: ACDF, anterior cervical discectomy and fusion; DDD, degenerative disc disease; NA, not available; NR, none reported; PC, prospective cohort; PEEK, polyetheretherketone; RC, retrospective cohort; RCT, randomized controlled trial.
a Fusion rate reported at 4 years.
b Eighty patients were included in the study. The number of patients allocated to each group was not reported.
c Fusion rate reported at unknown time period.
d Fusion rate reported at 1 year.
e Fusion rate reported at 2.4 years.
Definitions of Fusion in Studies of Structural Allograft and PEEK Interbody Devices in Patients With Cervical Spine Degeneration Who Underwent Anterior Cervical Discectomy and Fusion.
| First Author, Year | Definition of Fusion |
|---|---|
| Feiz-Erfan,[ | Absence of major angular motion (≤2°) on flexion/extension radiographs and <50% lucency at each potential fusion surface. |
| Campbell,[ | “The presence of bridging trabecular bone as evidenced by continuous bony connection of the vertebral bodies above and below in at least one of the following areas: lateral, anterior, posterior, and/or through the allograft ring implant; angulation of less than 4° on flexion-extension radiographs; and absence of radiolucency covering more than 50% of either the superior or inferior surface of the graft.” |
| Feng,[ | “1) rotation <4° and <1.25 mm translation with the absence of motion adjacent to interspinous processes (>3 mm) in the flexion-extension view and (2) the presence of continuous trabecular bone bridging was revealed by CT scan in at least one of the following locations: anterior, within, or posterior to the PEEK cage.” |
| Coric,[ | “1) bridging trabecular bone; 2) angular motion less than 5°; 3) translational motion less than 3 mm; and 4) less than 50% radiolucency along the bone-implant interface.” |
| Gornet,[ | “1) angulation ≤4°, 2) bridging bone as a continuous bony connection with the vertebral bodies above and below, and 3) no radiolucency covering more than 50% of either the superior or inferior surface of the graft.” |
| Hisey,[ | “Bridging bone across the disk space, <2 degrees angular motion measured from flexion to extension, and <50% radiolucent lines at the graft vertebral endplate interfaces.” |
| Mummaneni,[ | “1) bone spanning the two VBs in the treated segment; 2) less than 4° of motion on dynamic radiographs; and 3) radiolucencies covering no more than 50% of the implant surface.” |
| Suchomel,[ | According to criteria of Brown et al[ |
| Zigler,[ | Unknown |
| Schlosser,[ | No radiolucency within the construct and no evidence of instrumentation failure. |
| Niu,[ | “Lack of a radiolucent line between the cage and endplate as well as the lack of translation or angulation change in the lateral cervical flexion-extension radiographs at the 1-year follow-up.” |
| Cabraja,[ | “Movement of less than 2° was measured, and by the absence of motion between the spinous processes on lateral flexion-extension radiographs.” |
| El-Tantawy,[ | “…continuity of the trabeculae between end-plates with the absence of lucency at the cage/end-plate interface. This was confirmed by stability on dynamic views (not more than 2 mm widening of the inter-spinous distance) or by CT in suspected fusions.” |
| Dufour,[ | On CT scan, “excellent fusion,” bone continuity on ≥1 image in both planes; “good fusion,” bone continuity on ≥1 image in 1 plane; “no fusion,” no visible bone continuity in any plane. |
Abbreviations: CT, computed tomography; PEEK, polyetheretherketone; VB, vertebral body.
Power Calculation, Sample Size, and Reporting of Patients Lost to Follow-up.
| First Author, Year | OCEBM Level of Evidence | Who Assessed Fusion | Power Calculation and Sample Size | Follow-up Rate, % (Follow-up duration, y) |
|---|---|---|---|---|
| Feiz-Erfan,[ | II | Physician not in study | NR | 85 (2) |
| Campbell,[ | I | Physician not in study | NR | NR |
| Feng,[ | II | 2 Blinded physicians | NR | NR |
| Coric,[ | II | Physician not in study | NR | 87 (2) |
| Gornet,[ | I | Physician not in study | Reported | 85 (2) |
| Hisey,[ | II | Physician not in study | Reported | 79 (4) |
| Mummaneni,[ | II | Physician not in study | NR | 75 (2) |
| Suchomel,[ | III | Treating surgeon and independent radiologist | NR | 99 (2) |
| Zigler,[ | III | Physician not in study | NR | 1-level: 82 (5); 2-level: 90 (5) |
| Schlosser,[ | IV | Physician not in study | NR | 94 (2) |
| Niu,[ | IV | Physician not in study | NR | NR |
| Cabraja,[ | IV | NR | NR | NR |
| El-Tantawy,[ | IV | NR | NR | 100 (2) |
| Dufour,[ | IV | NR | NR | 100 (1) |
Abbreviations: NR, not reported; OCEBM, Oxford Centre for Evidence-Based Medicine.